Calypte und die Zeit nach AIDS2004 in Bangkok

 

aber sei dir sicher, einige der neuen hier werden dich später mal dafür steinigen, dass du ihnen nur rosarotgefärbte kacke erzählst.

und zwar mit recht.  

"initial" field tests bedeutet nicht die ersten Tests von vielen, sondern "anfänglich" in dem Sinne, dass wenn die Ergenbisse gut sind (und das sind sie!) normalerweise die Produktion folgt.

So wie "Initialzündung". Und dann gehts ab !  

auch andere haben schon oft genug versucht mit Dir sachlich zu diskutieren.
Aber seit fast nem Jahr kommt von Dir immer nur der gleiche Schrott ! Sachliche Fakten kannst Du in diesem Thread von sämtlichen Teilnehmern und auch von mir sehr, sehr viele nachlesen. Nur von Dir immer die gleiche langweillige Aussage. Gääähhhn...

Propagiere Du einfach weiter Deine IFEX = 0,90 bis Ende Mai, Juni, Juli... aber bitte im w.o.-Board !  

leider der wahrheit, auch wenn ihr sie nicht hören wollt.

ihr könnt noch so víel fakten über aids in das board stellen, dadurch wird caly nicht besser, aber das zählt bei euch nicht. ihr sülzt euch eure wahrheit schön.

dann sage mir mal bitte, wann caly seine neuen rapid-tests auf den markt bringt(der im übrigen blut-basiert ist)?

was sagst du denn zu den anderen bluttests, die schon auf dem markt sind, die eine infektion innerhalb von 10 min. nachweisen, wie z.b. der von trinity?

welche großaufträge hat caly denn bisher mit seinen tollen produkten an alnd gezogen? kooperationen in afrika und asien existieren doch schon seit 1-2 jahren????

warum ist denn calys urintest nicht der absolute renner und verkauft sich millionenfach??? könnte es sein, dass das daran liegt, das er nur HIV-1 feststellen kann?

wenn schon nicht dir mein lieber kade, aber einigen neuen hier sollten diese fakten sehr wohl zu denken geben.

und jetzt komme mir bitte nicht wieder mit polemik oder phrasendrescherei, mit der du deine elende pusherei verteidigtst!!!
 

 

damit die Amis unseren Kursen hinterher laufen *ggg*

Prost jölölü  

was haltet ihr von einer Schlichtung!
Habe zufällig euren Streit auch im WO Board gelesen.
Kade ist überzeugt von Caly. OK
Joelu warnt vor Caly. OK
Zwei verschiedene Meinungen.
Wo ist das Problem?
Ich denke ,der Eine braucht den Anderen nicht zu
kritisieren und zu belehren.
Jeder soll doch das Tun was er für richtig hält. Ok
Was haltet ihr davon.
 

rennt mir denn Joelö von w.o. bis in diesen thread hinterher ? Will also ich meine Ruhe oder er seine ?  

 

Ich persönlich hab meine Meinung über jöelu geäusert.
Ich denke das wir Ihn ignorieren sollten.
Ignoranz wäre die beste Bestrafung für jöelu

Gruß

C.O  

Ich denke die Aussage vom Dr. Maanen ist für uns allen verständlich.
Wenn er schon sehr zufrieden ist mit der präsentation und vom Publikum,wird das schon seinen Grund haben.

"Wir haben eine erfolgreiche Sitzung auf der XV Internationalen AIDS-Konferenz in Bangkok, Thailand in dieser Woche, die Ergebnisse unserer Feldversuche unserer Studien von Thailand präsentierend, die 1,000 Themen überdecken," sagte Dr Richard George, der Präsident von Calypte und Geschaftsführer.




" Ich bin mit der Leistung dieser Feinproben in ihrem anfänglichen praktischen Versuch sehr zufrieden. Die Leistung des Bluts schneller Test ist auf einem Durchschnitt mit den besten schnellen Labor-HIV-Antikörper-Tests zurzeit auf dem Markt. Der Calypte prüft diesen Test nichtangreifende alternative Flüssigkeiten gezeigt Leistung vergleichbar mit oder lieber als andere solche zurzeit vorhandene Feinproben. Wenn auch wir andere Gültigkeitserklärungsstudien entweder im Fortschritt oder während dessen haben und wir fortsetzen, diese Feinproben zu verbessern, macht diese Studie unsere Entscheidung gültig zu beginnen zu verfertigen und Kommerzialisierung dieser Feinproben für den internationalen Markt. Wir glauben die Verfügbarkeit von diesen sichere, genaue und wirtschaftliche Feinproben werden die Annahme der HIV-Prüfung vergrößern und werden zu mehr Menschen führen, die ihren HIV-Status wissen{kennen} und in Behandlungsprogramme eingeschrieben werden. "



Ich bin zuversichtlich was Großaufträge anbelangt .

Gruß

C.O  

finde es gut das joelu auch kritische Punkte postet.
Er wird dabei ja nicht beleidigent und ich halte seine Einwände für Informativ!
Abschliessend bleibt zu sagen das ich es gut finde wenn weiterhin sowohl posetive als auch negative Punkte zur Aktie hier gepostet werden!


Gruss Pate


 

und entscheiden muss jede(r) für sich. aber nur postive (oder nur negative) meinungen tolerieren...ist sehr blauäugig. fakt ist: erst wenn offizielle erfolge/misserfolge bekanntgegeben werden...passiert was.

gruss

forsale
 

blind ihren herdenführern folgen, sondern, dass einige das geschehen, die news und den kursverlauf kritisch betrachten.

schön, dass wenigstens einige hier die augen offen halten. das werden die sein, die am ehesten die notbremse ziehen werden.

glückwunsch!  

forsale usw.
In diesem Thread sind ALLE Meinungen zu Calypte erwünscht - auch die negativen. Ich habe hier weder und werde auch niemanden blöd antexten, bloß weil er von Calypte nichts hält - joelu ausgenommen. Ich hatte zusammen mit anderen im w.o.-Board vor ca. einem Jahr begonnen viele Infos zu Calypte zu posten- wie hier auch. Und hier sind, wie ihr wisst einige Infos zu Calypte von mir zu finden (von Euch natürlich auch).

Ich schreibe hier nicht den ganzen Tag wie toll doch Calypte sei oder denke mir irgendwelche Push-Geschichten aus, sondern poste hier Infos, die ich im www finde- ich nenne sie mal Daten, Fakten und Analysen. Ebenso Realtime-Kurse aus den USA.
Aber damals im w.o.-board kam dann irgendwann ein gewisser joelu, der allen die was positives zu Calypte schrieben vorwarf elende Pusher zu sein. Mit den immer gleichen Sprüchen provozierte er nicht nur mich. Er will uns alle vor Calypte retten- und das jeden Tag. Ist ja irgendwann dann mal ok und genug. Wir haben alle selbst ein Hirn, dachte ich zumindest.
Früher oder später mußte die Sache eskalieren, was dann ja auch geschah. Neben wenigen sachlichen Infos, gab es fast nur noch dumme Sprüche von allen Seiten (auch von meiner). Irgendwann hat man halt keinen Bock mehr Infos oder News zu posten, wenn man dafür immer angegriffen wird (mit immer gleichen Aussagen). Deshalb entschied ich mich nach fast 4 Jahren w.o.-Mitgliedschaft meine Motivation ins ariva-board einzubringen und habe unteranderem auch joelu geschrieben, dass ich keinen Bock mehr auf ihn und sein Kindergarten-Kram habe (könnt Ihr alles in w.o. fast ein Jahr rückwirkend nachlesen).
So, und nun ?! Er meldet sich hier an, folgt mir also um mich weiter vollzutexten und schreibt hier dann auch noch, dass er sachliche Diskussionen und Antworten von mir ihm gegenüber wünscht ! Was soll ich dazu noch sagen ?!

Ich hoffe, Ihr versteht was ich meine.

Meine Motivation hier täglich zusammen mit Euch zu posten ist ganz einfach "der Spaß an der Freude". Ich habe hier nie versucht jemanden dazu zu bewegen Calypte zu kaufen. Aus Info-Postings sollte jeder seine eigenen Schlüße ziehen ! Mehr nicht. Ich habe auch meine gesunde Vorsicht Calypte gegenüber und sage bestimmt nicht, dass alles toll ist was die machen. Aber ich rechne mir zukünftig trotzdem viel für Caly aus.

Einen Wert wie Calypte kann man in Deutschland definitiv nicht pushen- weshalb wird man hier also regelmäßig von joelu als "elender Pusher" bezeichnet ?!

Leute, ich will genauso wie Ihr hier meinen Spaß haben und habe keinen Bock auf erneute Dispute mit joelu wie im w.o.-board. Ansonsten spar ich mir zukünftig die Zeit, die ich hier bisher gerne mit Euch verbrachte. Andere kritische Meinungen zu Caly sind hier aber jederzeit erwünscht !


Deshalb joelü: Bitte bleibe bei w.o. Es hat keinen Sinn mit Dir eine weitere Diskussion anzufangen. Ich finde es beinahe lächerlich, dass Du mir hierher folgst. Du mußt niemanden retten - glaub´s mir bitte ! Und denke daran: Wer deinen Tipps bisher folgte, machte bis auf wenige Ausnahmen deutliche Verluste !(auch in w.o.- nachzulesen)

Sorry, aber das mußte ich jetzt einfach mal loswerden...

Grüße an alle (sogar an jeölu)

Kade_I
;-)  

Informal Inquiry by SEC

By letter dated July 14,  2004,  the SEC  Division of  Enforcement  notified the
Company that the matter has been  terminated and that no enforcement  action has
been recommended by the Commission at this time.

Na also ;-)  

für mich sind das "erste bzw. anfängliche" Tests in dem Sinne, das sie zwar erfolgreich waren, allerdings müssen weitere Tests folgen bzw. wird das Produkt verbessert.

Ansonsten wird generell eine Markteinführung angestrebt, lt. CEO.
Ob das langfristig zum Erfolg führt, wird sich zeigen. Derzeit würde ich eher nur traden als Caly als Langzeitinvestment anzusehen.






 

Kam gestern nachbörslich raus. Stehen viele interessante Infos inside !
Übrigens auch die Info, dass die SEC-Untersuchung abgeschlossen ist, stammt aus diesem Filling.
Auch im Raging-Bull-Board wird das filling äußerst positiv aufgenommen.

Grüße
Kade_I  

Du schreibst "für mich sind das "erste bzw. anfängliche" Tests in dem Sinne, das sie zwar erfolgreich waren, allerdings müssen weitere Tests folgen bzw. wird das Produkt verbessert"

First Phase of field trials, ... Second Phase ... "we believe that we have finalized our
blood rapid test." (siehe unten)

Testphasen des Blood-Rapid-Tests sind laut Calypte also abgeschlossen, Test ist fertig !
Der Rapid-Urin-Test wird noch weiter entwickelt.

We have already  conducted  in-house trials of our development stage blood, oral
fluid and urine rapid tests and have conducted field  evaluations in Thailand to
validate the performance of these products.  Through the validation process, any
enhancements  necessary  and/or desired in the performance of the rapid tests in
the field are worked on in the  laboratory.  The  reworked  rapid tests are then
returned to the field for further  evaluation.  This  process is  iterative  and
precedes  the  larger  clinical  trials  that will be  required  for  regulatory
approval in many  countries  prior to bringing  the  products to market.  In our
first phase of field  trials,  we tested our  development-stage  blood and urine
rapid  tests.  These  studies  identified  certain   refinements  that  we  have
implemented.  We have subsequently conducted a second phase of field trials that
included our developmental stage blood, oral fluid and urine rapid tests.

We began the second phase of external validation trials of our blood, oral fluid
and  urine  rapid  HIV  antibody  assays  in April  2004 at the  Thai Red  Cross
Anonymous HIV Clinic in Bangkok,  Thailand.  We completed this  prospective  and
random  study in June 2004 and  provided  the  results  to  delegates  of the XV
International  AIDS  Conference  held July 11-16,  2004 in  Bangkok.  This study
tested  a total  of 1023  subjects,  392  seropositive  subjects,  including  37
seropositive  subjects receiving  anti-retroviral  therapy, and 631 seronegative
subjects.  The true antibody  status of these subjects was determined by testing
of a blood  sample  using the  standard  testing  method  routinely  used by the
Anonymous  Clinic  for  diagnostic  testing.  Our  blood  rapid  test  was  100%
concordant  with the results of the standard  blood  tests.  Our oral fluid test
demonstrated  99.5%  sensitivity  (390 of 392 subjects).  The two false negative
results  were  from two  known  positive  subjects  who were on  anti-retroviral
therapy.  These patients are known to have diminished  antibody levels and would
not normally be seeking HIV  diagnostic  testing.  The  specificity  of the oral
fluid test was 100%. Our rapid urine assay was found to be 99.0%  sensitive (388
of 392 subjects) and 100% specific. Our rapid blood, oral fluid, and urine tests
correctly identified 1023 of 1023 subjects,  1021 of 1023 subjects,  and 1019 of
1023 subjects for an overall accuracy of 100%, 99.8%, and 99.6%, respectively.

Based on our field study results to-date,  we believe that we have finalized our
blood  rapid test.  We are making  plans to conduct a formal  clinical  trial in
China using the blood test, as well as our oral fluid and urine rapid tests.  We
expect that  clinical  trial to be  completed in the third  quarter of 2004.  We
believe that we have  successfully  field tested and are now finalizing our oral
fluid test. We plan to initiate manufacturing of the oral fluid test in Thailand
shortly  following the start-up of blood test  manufacturing.  We are continuing
the development process for our urine rapid test. Urine contains a lesser amount
of antibody than either blood or oral fluid,  making the the  identification  of
those  individuals  with low  levels  of  antibodies,  especially  those who are
receiving  anti-retroviral  therapy, even more difficult.  While we believe that
the results to date are acceptable,  we are continuing the iterative development
process and are evaluating other  alternatives for our urine test, some of which
we may  choose to test in new  field  trials.  If the  results  of those  trials
demonstrate  improved  accuracy versus the current  version,  we would conduct a
separate clinical trial using the revised test format.  While we expect that our
efforts  will result in a finalized  version of the urine test no later than the
third  quarter  of 2004,  there can be no  assurance  that we will  successfully
manufacture  or  commercialize  a urine  rapid test,  or our other rapid  tests,
within that timeframe, or at all.

Our urine test  development  efforts  have  identified  certain  unique  product
properties  and  processes  that  we plan  to  protect.  We  believe  that  this
intellectual  property is significant  as it may result in a blocking  patent to
those who may  consider  urine  testing by  protecting  a key step  necessary in
achieving the highest levels of specificity.

As  mentioned  above,  we plan to  initially  manufacture  our  rapid  tests  in
Thailand.  In  preparation  for  our  first  foreign  manufacturing   technology
transfer,  we announced on May 11, 2004 that we have  finalized a  non-exclusive
contract  manufacturing  agreement with Thailand-based Pacific Biotech Co., Ltd.
to act as our initial  international  manufacturer for our HIV-1/2 blood,  serum
and plasma rapid  tests.  Manufacturing  will be located at the Pacific  Biotech
facility in Phetchaboon,  Thailand. We have commenced the technology transfer of
the blood rapid test with the objective of completing our first pilot production
lots in the third quarter of 2004.  Further,  on May 13, 2004, we announced that
we have selected Beijing Tiantan  Biological  Products Co, Ltd.  ("BTBP") as our
manufacturing  partner for the  production  of our rapid tests in China.  On the
basis of a memorandum of understanding  between the parties,  BTBP has commenced
the construction of a manufacturing site in China where the HIV rapid tests will
be produced.

aus dem am 16.07.04 erschienen Filling !
 

Incidence  Tests.  On April 12, 2004, we announced  that the Centers for Disease
Control and Prevention ("CDC") had granted us a worldwide, non-exclusive license
enabling  us to use  technologies  developed  by  the  CDC  to  manufacture  and
commercialize  a  serum  enzyme  immunoassay  (HIV  1-EIA)  that  can be used to
estimate  the  proportion  of HIV  infections  that are  recently  acquired in a
population  (infections occurring in the last 6-8 months). This laboratory assay
can be used to identify those regions and the  populations  within those regions
where  HIV  transmission  is  occurring  most  recently.   Once  our  production
capabilities are in place, the CDC will no longer supply this product. We expect
to have this product available for international distribution in the second half
of 2004.  On April 14,  2004,  we  announced  that we had  executed  a CRADA - a
Cooperative  Research  and  Development   Agreement  -  with  the  CDC  for  the
development of a new HIV rapid blood assay. Like current rapid test assays,  the
proposed device will be for diagnostic use to detect HIV antibodies, but it will
also be used to determine the proportion of HIV-1  infections that have occurred
in the last six months.  The purpose of the test is to provide a simplified  and
rapid format that can be performed in resource poor settings and remote outreach
locations for diagnostic and surveillance purposes.

 

die Aüsserungen von joelu nicht ignorieren sondern hinterfragen und zwar indem ihr euch mal selber schlau macht. Schaut nach in den Fillings und den PR`s, immer gab es Invests und ausserbörsliche Aktivitäten, immer wieder gerade in dem Hype gab es Infos und PR`s aber nichts hat gefruchtet.....

Jeder ist seines Glückes Schmied!

Leute wacht auf und lest mal mit klaren Augen die Fillings und PR`S!!!

@Lucky
die Abzocke war da als jede Woche eine PR rauskam und der Kurs getrieben wurde...d.y.o.r.!



Jovi  

 

Additionally, the Board of Directors has directed management to implement the
American Stock Exchange corporate governance standards (SR-AMEX-2003-65)
approved by the Commission on December 1, 2003  

Tonnenweise Risk-Factors zu Calypte. Dass auch keiner sagen kann, die Betrachtung von Calypte ist nur einseitig !


RISK FACTORS

In addition to the other information in this Prospectus,  Calypte has identified
a number of risk factors that the Company faces.  These  factors,  among others,
may cause actual results,  events or performance to differ materially from those
expressed in any forward-looking  statements made in this Prospectus or in other
filings with the  Securities  and Exchange  Commission  or in press  releases or
other public  disclosures.  Investors  should be aware of the existence of these
factors and should  consider them  carefully in evaluating  our business  before
purchasing the shares offered in this Prospectus.

                   Risks Related to Our Financial Condition

If We are Unable to Obtain Additional Financing When and If Required We May Have
to  Significantly  Curtail the Scope of Our  Operations  and Alter Our  Business
Model.

We believe that the aggregate of approximately  $10.2 million of net proceeds of
our 2004 private  placements and the availability of approximately  $3.6 million
of  borrowing  capability  from 9%  promissory  notes that we may issue  through
December  31, 2004 under the terms of the amended Marr Credit  Facility  will be
adequate to sustain our operations at expected  levels through 2004.  There can,
however,  be no assurance that such resources will be adequate.  Further,  there
can be no assurance  that we will be able to achieve  expanded  acceptance of or
realize  significant  revenues  from our  current  or  potential  new  products,
including our rapid tests, or that we will achieve  significant  improvements in
the  efficiency  of  our  manufacturing  processes.  In  addition,  there  is no
assurance that we will achieve or sustain  profitability  or positive cash flows
in the future. In the absence of adequate resources from current working capital
and existing financing, we would need to raise additional capital to sustain our
operations.  In that case,  we would or might be required to consider  strategic
opportunities,   including  merger,  consolidation,  sale  or  other  comparable
transaction,  to sustain our operations. We do not currently have any agreements
in place with  respect to any such  strategic  opportunity,  and there can be no
assurance that any such opportunity will be available to us on acceptable terms,
or at all. If  additional  financing is not  available to us when required or is
not available to us on acceptable  terms, or we are unable to arrange a suitable
strategic  opportunity,  we will be in significant financial jeopardy and we may
be unable to continue our operations at current levels,  or at all. The terms of
a  subsequent  financing  may involve a change of control,  require  stockholder
approval,  and/or trigger anti-dilution protection clauses contained in existing
financing  agreements that would result in substantial  dilution to our existing
stockholders  or might  require  us to pledge  the  rights to our  products  for
collateral security for the issuance of a convertible debt security.


                                      5



Our Financial  Condition has  Adversely  Affected Our Ability to Pay  Suppliers,
Service  Providers  and  Licensors  on a Timely Basis Which May  Jeopardize  Our
Ability to Continue Our Operations and to Maintain  License Rights  Necessary to
Continue Shipments and Sales of Our Products.

As of March 31, 2004 our accounts  payable  totaled $2.0 million,  of which $1.5
million  was  over  sixty  days  old.  We  currently  have  primarily  cash-only
arrangements  with suppliers and certain  arrangements  require that we pay down
certain outstanding  amounts due when we make a current payment.  These past due
payments  vary  monthly   depending  on  the  items  purchased  and  range  from
approximately  $50,000  to  $200,000  per  month.  As of March 31,  2004 we have
accrued an aggregate of  approximately  $551,000 in royalty  obligations  to our
patent licensors,  of which  approximately  $387,000 were past due. The licenses
attributable to past due royalty payments relate to technology  utilized in both
our urine EIA screening test and our supplemental urine and serum tests. Because
of the  interdependence  of the screening and supplemental  tests in our testing
algorithm,  the  inability  to use any one of the  patents  could  result in the
disruption of the revenue stream from all of our products. While at this time we
are current  with our payment  plans for past-due  amounts,  if we are unable to
maintain  sufficient  working capital,  our ability to make payments on past due
negotiated royalty obligations,  make timely payments to our critical suppliers,
service providers and to licensors of intellectual property used in our products
will be  jeopardized  and we may be  unable  to  obtain  critical  supplies  and
services and to maintain  licenses  necessary for us to continue to manufacture,
ship and sell our products. Additionally,  certain vendors and service providers
with whom we have not  currently  arranged  payment  plans have or may choose to
bring legal action against us to recover amounts they deem due and owing.  While
we may dispute these claims,  should a creditor  prevail,  we may be required to
pay all amounts due to the creditor.  If the working capital that will enable us
to make the required  payment is not available when required,  we will be placed
in  significant  financial  jeopardy  and we  may  be  unable  to  continue  our
operations at current levels, or at all.

We Have Incurred Losses in the Past and We Expect to Incur Losses in the Future.

We have incurred  losses in each year since our inception.  Our net loss for the
quarter  ended March 31, 2004 was $4.0  million and for the year ended  December
31,  2003 was $26.5  million and our  accumulated  deficit at March 31, 2004 was
$131.9 million.  We expect  operating losses to continue during 2004 and perhaps
beyond,  as we complete  the  development  and begin  commercializing  our rapid
tests, complete our manufacturing  restructuring and consolidation,  and conduct
additional research and development for product improvements and clinical trials
on potential new products.

An Economic Downturn or Terrorist Attacks May Adversely Affect Our Business.

Changes in economic conditions could adversely affect our business. For example,
in a difficult  economic  environment,  customers  may be unwilling or unable to
invest in new  diagnostic  products,  may elect to  reduce  the  amount of their
purchases or may perform less HIV testing.  A weakening  business  climate could
also  cause  longer  sales  cycles  and slower  growth,  and could  expose us to
increased  business or credit risk in dealing with customers  adversely affected
by economic conditions.

Terrorist attacks and subsequent  governmental  responses to these attacks could
cause further  economic  instability or lead to further acts of terrorism in the
United  States and  elsewhere.  These actions could  adversely  affect  economic
conditions  outside  the  United  States  and  reduce  demand  for our  products
internationally. Terrorist attacks could also cause regulatory agencies, such as
the FDA or agencies that perform similar functions outside the United States, to
focus their  resources  on vaccines  or other  products  intended to address the
threat of  biological or chemical  warfare.  This  diversion of resources  could
delay our ability to obtain regulatory approvals required to manufacture, market
or sell our products in the United States and other countries.


                                      6





               Risks Related to the Market for Our Common Stock

The Price of Our Common Stock Has Been Highly  Volatile  Due to Several  Factors
Which Will Continue to Affect the Price of Our Stock.

Our common  stock has traded as low as $0.11 per share and as high as $1.799 per
share in the twelve  months  ended March 31,  2004.  We believe that some of the
factors leading to the volatility include:

o    price and volume  fluctuations  in the stock  market at large  which do not
    relate to our operating performance;

o    fluctuations in our operating results;

o    concerns about our ability to finance our continuing operations;

o    financing  arrangements  which may  require the  issuance of a  significant
    number of shares in relation to the number of shares currently outstanding;

o    announcements of technological  innovations or new products which we or our
    competitors make;

o    FDA, SEC and international regulatory actions;

o    availability of  reimbursement  for use of our products from private health
    insurers,   governmental  health   administration   authorities  and  other
    third-party payors;

o    developments with respect to patents or proprietary rights;

o    public concern as to the safety of products that we or others develop;

o    changes in health care policy in the United States or abroad;

o    changes in stock market analysts'  recommendations regarding Calypte, other
    medical products companies or the medical product industry generally;

o    fluctuations in market demand for and supply of our products;

o    certain world  conditions,  such as SARS, an economic downturn or terrorist
    attacks; and

o    anti-American sentiment in certain international markets.


Our  Registration  of a  Significant  Amount  of Our  Outstanding  Stock and the
Availability of a Significant Number of Shares Eligible for Future Sale May Have
a Negative Effect on the Trading Price of Our Stock.

At June 30, 2004,  investors in our common stock held  approximately  71 million
shares of restricted stock, of which  approximately  41.0 million shares related
to acquisitions of our common stock by Marr  Technologies BV ("Marr" or "MTBV"),
the  provider  of our  9%  promissory  note  credit  facility  and  our  largest
stockholder,  through their participation in private placements in 2003 and 2004
and conversion of debentures. Approximately 15.75 million additional shares were
related  to  issuances  of  restricted  shares  of our  common  stock  to  other
participants in our May 2004 private placement;  another 11.6 million restricted
shares  were  related  to  issuances  pursuant  to  our  convertible  notes  and
debentures and an additional 2.6 million shares were related to issuances  under
contracts  and  agreements  under  which we have  received  goods and  services.
Further,  in the  May  2004  private  placement  we  issued  warrants  that  are
immediately  exercisable  or exercisable on 61 days' notice that could result in
the issuance of an  additional  8.8 million  shares.  Additionally,  we could be
required  to issue  approximately  2.9 million  additional  shares of our common
stock if the holders of currently outstanding  convertible debentures or various
warrant holders elected to convert the remaining  principal and accrued interest
of their  debentures  or exercise  their  outstanding  warrants.  We  registered
essentially all of the outstanding restricted shares as of June 30, 2004 and the
shares  underlying  the  outstanding  convertible  debentures  and warrants in a
registration  statement that became effective on July 8, 2004.  Although certain
of the Marr agreements  require that Marr hold approximately 28.2 million of its
its shares for one year following their  purchase,  essentially all of the other
shares  are now  freely  tradable  or  would be so upon  the  conversion  of the
debentures or exercise of the warrants.  Futhermore,  investors in our July 2004
private  placement  currently  hold  approximately  3.7  million  shares  of our
restricted stock and immediately  exercisable warrants to purchase an additional
2.6 million  shares.  We are  including  the  outstanding  shares and the shares
underlying the warrants in this registration  statement.  If investors holding a
significant  number of freely  tradable  shares  decided to sell them in a short
period of time, such sales could contribute significant downward pressure on the
trading price of our stock.  Such sales might also inhibit our ability to obtain
future equity or equity-related financing on acceptable terms.


                                      7



From inception through July 14, 2004, we have issued approximately 168.0 million
shares of our common stock and raised  approximately $140 million.  At a Special
Meeting of  Stockholders  on February 14,  2003,  our  stockholders  approved an
increase in the number of authorized  shares of the Company's  common stock from
200  million  to 800  million.  Although  we have no plans to do so, at July 15,
2004, we have the ability,  without further  stockholder  approval,  to issue in
excess of 500  million  shares of our common  stock for  financing  or for other
purposes.  The perceived  risk of dilution  from this amount of  authorized  but
unissued  stock may cause our existing  stockholders  and other  holders to sell
their shares of stock,  which would contribute to a decrease in our stock price.
In this regard,  significant downward pressure on the trading price of our stock
may  also  cause  investors  to  engage  in short  sales,  which  would  further
contribute to significant downward pressure on the trading price of our stock.


Our Issuance of Warrants,  Options and Stock Grants to Consultants  for Services
and the  Granting of  Registration  Rights for the  Underlying  Shares of Common
Stock May Have a Negative Effect on the Trading Price of Our Common Stock.

As we  continue  to look for ways to  minimize  our use of cash while  obtaining
required services, we have issued and may continue to issue warrants and options
at or below the current  market  price or make  additional  stock bonus  grants.
During  2003,  we issued  warrants,  options  and stock  bonuses for nearly 19.8
million  shares,  including  approximately  10.0  million  shares from  employee
benefit  plans and the 2003  Non-Qualified  Stock  Option  Plan,  in payment for
consulting  services.  In the first  quarter  of 2004,  we issued  approximately
596,000 additional shares in payment for consulting services. In addition to the
potential  dilutive  effect of a large number of shares and a low exercise price
for the warrants and options,  there is the potential that a large number of the
underlying  shares may be sold on the open market at any given time, which could
place downward pressure on the trading price of our common stock.


Our Stockholders May Experience  Substantial  Dilution as a Result of Our Recent
PIPE  Financings  and the  Anti-Dilution  Provisions  Contained  Therein or as a
Result of Future Financings.

The current market price of our common stock and the price at which investors in
the May 2004 PIPE and the July 2004 PIPE purchased shares of our common stock is
significantly  higher than the book value of our common stock. Had the 2004 PIPE
transactions  occurred in aggregate as of March 31, 2004,  the  investors  would
have invested,  net of fees, an amount equal to  approximately  $12.3 million in
excess of our total  stockholders'  equity as of that  date,  but would own only
approximately 16% of our outstanding common stock.

Although we believe that we have  sufficient  funds to continue  our  operations
through 2004, we may need to arrange additional financing to fund our operations
in 2005 or thereafter. There can be no assurance that additional financing would
be  available,  or it if is  available,  that it would be on  acceptable  terms.
Additionally,  the shares issued pursuant to the May 2004 PIPE and the July 2004
PIPE and the related warrants for each have an  anti-dilution  feature that will
require us to issue  additional  shares to the PIPE  investors  and modify their
outstanding  warrants if we subsequently  issue additional equity at a per share
price of less than  $0.40 for a period of one year from the  respective  closing
dates, except under the provisions of previously  outstanding  convertible debt,
option plans, or option or warrant agreements.  If we find it necessary to issue
additional  common stock to fund our  operations  in the year  following the May
2004  PIPE and the July  2004  PIPE,  all of our  stockholders  will  experience
dilution;  if the terms of the potential future financing  require that we issue
shares of our common  stock at a price of less than $0.40 per share,  holders of
our  common  stock  prior  to  the  2004  PIPEs  will  experience  even  greater
proportional dilution.


Our  Common  Stock is  Subject  to the  "Penny  Stock"  Rules of the SEC and the
Trading Market In Our  Securities is Limited,  Which Makes  Transactions  in Our
Stock Cumbersome and May Reduce the Value of an Investment in Our Stock.


                                      8



Shares of our common stock are "penny  stocks" as defined in the  Exchange  Act,
which are traded in the Over-The-Counter  Market on the OTC Bulletin Board. As a
result,  investors may find it more  difficult to dispose of or obtain  accurate
quotations  as to the price of the shares of the common  stock being  registered
hereby. In addition, the "penny stock" rules adopted by the Commission under the
Exchange  Act  subject  the sale of the  shares of our  common  stock to certain
regulations  which impose sales practice  requirements  on  broker/dealers.  For
example,  brokers/dealers  selling such securities  must, prior to effecting the
transaction, provide their customers with a document that discloses the risks of
investing in such securities. Included in this documents are the following:

o    the bid and offer price quotes in and for the "penny stock", and the number
    of shares to which the quoted prices apply.

o    the brokerage firm's compensation for the trade.

o    the  compensation  received by the  brokerage  firm's  sales person for the
    trade.

In addition, the brokerage firm must send the investor:

o    a monthly  account  statement  that gives an  estimate of the value of each
    "penny stock" in the investor's account.

o    a written  statement of the investor's  financial  situation and investment
    goals.

Legal remedies,  which may be available to you as an investor in "penny stocks",
are as follows:

o    if "penny  stock" is sold to you in violation of your rights  listed above,
    or other federal or states  securities laws, you may be able to cancel your
    purchase and get your money back.

o    if the stocks are sold in a fraudulent  manner,  you may be able to sue the
    persons and firms that caused the fraud for damages.

o    if you have  signed  an  arbitration  agreement,  however,  you may have to
    pursue your claim through arbitration.

If the person  purchasing  the  securities  is someone  other than an accredited
investor or an established customer of the broker/dealer, the broker/dealer must
also  approve  the  potential   customer's  account  by  obtaining   information
concerning  the  customer's  financial  situation,   investment  experience  and
investment objectives.  The broker/dealer must also make a determination whether
the  transaction  is suitable  for the  customer  and whether the  customer  has
sufficient  knowledge  and  experience  in  financial  matters to be  reasonably
expected  to  be  capable  of  evaluating  the  risk  of  transactions  in  such
securities.  Accordingly,  the  Commission's  rules  may  limit  the  number  of
potential purchasers of the shares of our common stock.

Resale restrictions on transferring "penny stocks" are sometimes imposed by some
states,  which may make  transaction  in our stock more difficult and may reduce
the value of the investment.  Various state securities laws pose restrictions on
transferring  "penny stocks" and as a result,  investors in our common stock may
have the ability to sell their shares of our common stock impaired.


                         Risks Related to Our Business

We May Be  Unsuccessful  in  Implementing  Our  Consolidation,  Development  and
Marketing Plans as Anticipated.

We are in the process of consolidating our manufacturing  facilities in a single
facility at our Rockville, Maryland location. In addition to internal validation
and comparability  studies that we conduct in conjunction with our manufacturing
consolidation,  the  FDA  must  approve  our  facility  changes  and  urine  EIA
manufacturing  operations in Rockville before we will be permitted to sell urine
EIA tests manufactured at that facility in the US. If the consolidation does not
proceed as planned,  or if the FDA does not approve the facility  changes on the
timeline  anticipated,  the  anticipated  cost  reductions  as well as increased
efficiencies may not occur.  There can be no assurance that we will successfully
complete the  development  and  commercialization  of our rapid tests  currently
under development,  or that our international  marketing efforts with respect to
these tests will result in significant additional sales. Additionally, there can
be no assurance  that we will be able to  successfully  negotiate  government or
private-sector  contracts  for  mass-testing  applications.   Consequently,  our
current financial  resources and available  financing may be inadequate,  and we
may  have to seek  additional  financing,  which  may  not be  available  on the
timetable  required  or on  acceptable  terms,  or we may  have to  curtail  our
operations, or both.


                                      9



In conjunction with our manufacturing  consolidation,  we expect that we will be
unable to  produce  our  HIV-1  Urine  EIA  product  for sale in the US until we
complete the required  validation  and  comparability  studies at our  Rockville
facility  that will be  necessary  for FDA  review and  approval.  We expect FDA
review and approval of our Rockville  facility to be completed  during the first
quarter of 2005. We believe we have manufactured  sufficient  inventories of our
HIV 1 Urine EIA test to continue to satisfy expected  customer orders during the
transition period. We have considered  historical sales levels and the length of
time  required  to  complete  the  consolidation  and  obtain  FDA  approval  in
determining  the amount of inventory  required to bridge the transition  period.
Demand could  significantly  exceed  historical  levels,  and  consolidation  of
operations or FDA approval  could take longer than  expected.  If one or more of
these events  occur,  then our  transition  inventory  may not be  sufficient to
supply customer  orders and we may lose business that we may find difficult,  or
impossible,  to replace.  Alternatively,  demand could fall significantly  below
historical levels, in which case we will have built excess inventory that we may
have to dispose of at additional cost, or at a loss.

Our Customers May Not Be Able to Satisfy Their  Contractual  Obligations  and We
May Not Be Able to Deliver Our Products as a Result of the Impact of  Conditions
Such as Severe Acute Respiratory Syndrome ("SARS") or Other World Events.

Our expected  first quarter 2003  shipment of urine HIV  screening  tests to our
distributor  in the  People's  Republic  Of China  was  delayed  until the third
quarter of 2003 in part as a result of the impact of the SARS  outbreak  in that
country.  Our distributor has reported that both potential  patients and medical
personnel were  reluctant to visit or report for work at hospitals,  clinics and
other sites for fear of contracting or spreading  SARS and,  consequently,  both
diagnostic   and   therapeutic   procedures   were   postponed.    Additionally,
governmentally-imposed  facility closures and quarantine  restrictions disrupted
the ability of the  distributor to receive and  distribute  our HIV tests.  This
situation may recur.

Our business model and future revenue forecasts call for a significant expansion
of sales in the People's  Republic of China as well as in Russia and Africa upon
successful  completion of the rapid product evaluation and regulatory  approval.
Should conditions beyond our control,  such as SARS, redirect attention from the
worldwide  HIV/AIDS  epidemic,  our customers' ability to meet their contractual
purchase obligations or our ability to supply product internationally for either
evaluation or commercial  use may prevent us from achieving the revenues we have
projected.  As a result,  we may have to seek additional  financing  beyond that
which we have projected, which may not be available on the timetable required or
on acceptable terms that are not substantially dilutive to our stockholders,  or
we may have to curtail our operations, or both.

Our Quarterly  Results May Fluctuate  Due to Certain  Regulatory,  Marketing and
Competitive Factors Over Which We Have Little or No Control.

The  factors  listed  below,  some of which we  cannot  control,  may  cause our
revenues and results of operations to fluctuate significantly:

o    actions  taken by the FDA or  foreign  regulatory  bodies  relating  to our
    existing  products or products we are  currently  developing  or seeking to
    develop;

o    the extent to which our  current  or  proposed  new  products  gain  market
    acceptance;

o    the timing and size of purchases by our laboratory customers,  distributors
    or joint venture partners;

o    introductions of alternative means for testing for HIV by competitors;

o    changes in the way requlatory  authorities evaluate HIV testing,  including
    supplemental testing of the domestic blood supply; and

o    customer  concerns  about the  stability of our business  which could cause
    them to seek alternatives to our product.

Our Research,  Development and Commercialization  Efforts May Not Succeed or Our
Competitors  May  Develop  and   Commercialize   More  Effective  or  Successful
Diagnostic Products.

In order to remain competitive,  we must regularly commit substantial  resources
to research and development and the commercialization of new products.


                                      10



The research and development  process  generally  takes a significant  amount of
time and money from  inception to  commercial  product  launch.  This process is
conducted in various stages.  During each stage there is a substantial risk that
we will not achieve our goals on a timely  basis,  or at all, and we may have to
abandon a product in which we have invested substantial amounts of money.

During the year ended  December  31, 2003 and in the first  quarter of 2004,  we
incurred  $1.5  million  and  $0.5  million,   respectively,   in  research  and
development  expenses.  We expect to incur even more significant  costs from our
research and development activities in the future.

A primary  focus of our  efforts  has been,  and is  expected to continue to be,
rapid HIV tests, which are currently under development. However, there can be no
assurance  that we will  succeed in our research  and  development  efforts with
respect to rapid tests or other technologies or products.

Successful  products require significant  development and investment,  including
testing,  to  demonstrate  their  cost-effectiveness  or other benefits prior to
commercialization. In addition, regulatory approval must be obtained before most
products may be sold.  Additional  development efforts on these products will be
required   before  any  regulatory   authority  will  review  them.   Regulatory
authorities  may not approve these  products for  commercial  sale. In addition,
even if a product is  developed  and all  applicable  regulatory  approvals  are
obtained,  there may be little or no market for the product, or we may be unable
to obtain  the  requisite  licenses  to sell the  product  or to  qualify  for a
government  tender,  which are often requirements in third world countries where
the  greatest  need  and  largest  market  for HIV  diagnostic  testing  exists.
Accordingly,  if we fail to  develop  commercially  successful  products,  or if
competitors  develop more  effective  products or a greater number of successful
new products,  or there are  governmental  limitations  affecting our ability to
sell our  products,  customers  may  decide  to use  products  developed  by our
competitors.  This would result in a loss of revenues and  adversely  affect our
results of operations, cash flows and business.

We Have Limited Experience Selling and Marketing Our HIV-1 Urine ELISA Tests and
No Experience Marketing a Rapid Test.

Our  urine-based  ELISA products  incorporate a unique method of determining the
presence of HIV antibodies and we have limited experience  marketing and selling
them either  domestically  or  internationally.  Further,  we have no experience
marketing  and  selling  blood or oral fluid  products.  Our  company's  success
depends upon alliances with  third-party  international  distributors  and joint
venture partners and upon our ability to penetrate  expanded markets.  There can
be no assurance that:

o    our international  distributors and joint ventures will successfully market
    our products;

o    our domestic selling efforts will be effective;

o    we will obtain any expanded degree of market  acceptance among  physicians,
    patients or health care payors;  or others in the medical or public  health
    community,  including governments and humanitarian funding sources critical
    in may  international  markets,  which are essential for  acceptance of our
    products; or

o    if our  relationships  with  distributors  terminate,  we  will  be able to
    establish  relationships with other distributors on satisfactory  terms, if
    at all.

We have had FDA  approval  to market  our  current  urine  HIV-1  screening  and
supplemental  tests in the United States and have been marketing  these products
since  1998.  We have not yet  introduced  either an HIV-1/2  product or a rapid
point of care  test,  both of which are  necessary  in many  areas of the world.
Further,  we have not achieved  significant  market penetration with our current
ELISA tests  within  domestic or  international  markets.  A  disruption  in our
distribution,  sales or marketing  network  could reduce our sales  revenues and
cause  us to  either  cease  operations  or  expend  more  resources  on  market
penetration  efforts than are available to us without  affecting  other parts of
our business.

We Currently  Depend Upon the Viability of Three  Primary  Products -- Our HIV-1
Urine-Based Screening Test and Our Urine and Blood Based Supplemental Tests.


                                      11



Our HIV-1  urine-based  screening  test and urine and  blood-based  supplemental
tests are our  current  products.  Our sales of these  products  for the quarter
ended March,  2004 increased by 24% compared to the  comparable  period in 2003.
There can be no  assurance,  however,  that such a trend will continue and, even
with the increase,  we still incurred a loss from operations for the quarter. If
we cannot  profitably  introduce  new  products  on a timely  basis and if these
products  and our  screening  and  supplemental  tests  fail to  achieve  market
acceptance or generate significant revenues, we may have to cease operations.

We May Not be Able to Successfully  Develop and Market New Products That We Plan
to Introduce.

We plan to develop other urine-based diagnostic products including rapid HIV-1/2
screening tests,  tests for other infectious  diseases or health  conditions and
serum-based  and oral-fluid  based rapid HIV-1/2  screening  tests.  We are also
transfering  technology  from the  Centers for  Disease  Control and  Prevention
("CDC") for an HIV ELISA incidence test and plan to develop, along with the CDC,
a blood-based rapid HIV test for diagnostic and surveillance purposes. There are
numerous  developmental and regulatory issues that may preclude the introduction
of these  products into  commercial  sale. If we are unable to  demonstrate  the
feasibility  of  these  products,   successfully  transfer  the  technology  for
commercial-scale  manufacturing to either internal,  joint venture or outsourced
manufacturers  or meet  regulatory  requirements  or  resolve  potential  patent
licensing or  government  distribution  licensing  requirements  with respect to
their  marketing,  we may have to abandon them and alter our business plan. Such
modifications to our business plan will likely delay  achievement of sustainable
cash flow from product sales and profitability. As a result, we may have to seek
additional financing, which may not be available on the timetable required or on
acceptable terms, or we may have to curtail our operations, or both.


A Market for Our Products May Not Develop.

Our future  success  will depend,  in part,  on the market  acceptance,  and the
timing of such acceptance, of new products such as our developmental stage rapid
HIV tests and  other new  products  or  technologies  that may be  developed  or
acquired.  To achieve  market  acceptance,  we must make  substantial  marketing
efforts and spend significant funds to inform potential customers and the public
of the perceived benefits of these products.  We currently have limited evidence
on which to evaluate the market reaction to products that may be developed,  and
there can be no assurance  that any products will obtain market  acceptance  and
fill the market need that is perceived to exist.


Our Success Depends on Our Ability to Protect Our Proprietary Technology.

The  diagnostics  test  industry  places  considerable  importance  on obtaining
patent,  trademark,  and trade secret protection,  as well as other intellectual
property  rights,  for new  technologies,  products and  processes.  Our success
depends,  in part, on our ability to develop and maintain a strong  intellectual
property  portfolio or obtain licenses to patents for products and  technologies
both in the United States and in other countries.

As  appropriate,  we  intend  to file  patent  applications  and  obtain  patent
protection for our proprietary technology. These patent applications and patents
will cover, as applicable,  compositions of matter for our products,  methods of
making those products,  methods of using those products,  and apparatus relating
to the use or manufacture of those products. We will also rely on trade secrets,
know-how, and continuing  technological  advancements to protect our proprietary
technology.  There is,  however,  no  assurance  that we will be  successful  in
obtaining any patent protection.

We have entered,  and will continue to enter,  into  confidentiality  agreements
with our employees,  consultants,  advisors and  collaborators.  However,  these
parties may not honor these  agreements  and we may not be able to  successfully
protect  our  rights to  unpatented  trade  secrets  and  know-how.  Others  may
independently  develop  substantially  equivalent  proprietary  information  and
techniques or otherwise gain access to our trade secrets and know-how.

Many of our  employees,  including  scientific and  management  personnel,  were
previously employed by competing companies. Although we encourage and expect all
of  our  employees  to  abide  by any  confidentiality  agreement  with a  prior
employer,  competing  companies may allege trade secret  violations  and similar
claims against us.

We may collaborate with  universities and  governmental  research  organizations
which,  as a  result,  may  acquire  part of the  rights  to any  inventions  or
technical information derived from collaboration with them.


                                      12



We may incur substantial costs and be required to expend  substantial  resources
in asserting or protecting our  intellectual  property  rights,  or in defending
suits against us related to intellectual  property  rights.  Disputes  regarding
intellectual  property rights could  substantially  delay product development or
commercialization  activities.  Disputes regarding  intellectual property rights
might  include  state,  federal or foreign  court  litigation  as well as patent
interference,  patent  reexamination,  patent reissue,  or trademark  opposition
proceedings  in the United  States Patent and  Trademark  Office.  Opposition or
revocation  proceedings  could be  instituted  in a foreign  patent  office.  An
adverse decision in any proceeding regarding  intellectual property rights could
result in the loss or  limitation  of our rights to a patent,  an  invention  or
trademark.

We are Dependent Upon Patents,  Licenses and Other Proprietary Rights From Third
Parties.

To facilitate  development  and  commercialization  of a proprietary  technology
base, we may need to obtain licenses to patents or other proprietary rights from
other parties.  Obtaining and maintaining  such licenses may require the payment
of substantial  amounts. In addition,  we currently have the right to use patent
and  proprietary  rights which are material to the  manufacture  and sale of our
HIV-1  urine-based  screening  test  under  licensing  agreements  with New York
University,  Cambridge Biotech  Corporation and the Texas A&M University System.
We also have the right to use  patent and  proprietary  rights  material  to the
manufacture  and sale of our HIV-1  serum- and  urine-based  supplemental  tests
under a licensing  agreement with National Institutes of Health. We will require
license  agreements  from certain of these  parties or other patent  holders for
technologies  used in our rapid tests and other  potential new  products.  As of
March 31, 2004 we had accrued an aggregate of approximately $387,000 in past due
royalty  obligations  to our  patent  licensors.  In  the  event  our  financial
condition  inhibits  our ability to pay royalty  payments  due under our license
agreements,  our rights to use those  licenses could be jeopardized in the event
of a default in payment of  royalties.  Specifically,  during the 2003  calendar
year and the first quarter of 2004, revenues subject to the New York University,
Cambridge  Biotech and Texas A&M license  agreements  were $2.0 million and $0.6
million, respectively, and revenues subject to the National Institutes of Health
agreement  were $1.3 million and $0.4 million in calendar  2003 and in the first
quarter of 2004,  respectively.  The loss of any of the foregoing licenses could
have a  materially  adverse  effect on our  ability to  continue  to produce our
products since the license agreements provide necessary proprietary processes or
components for the manufacture of our products.

The Sales  Potential  for the Rapid  Test  Products  We Are  Developing  Will be
Affected by Our Ability to Obtain Certain Licenses.

There are two primary  factors that will affect the specific  countries in which
we will be able to sell our  rapid  HIV tests  that are  under  development  and
therefore the overall sales potential of the tests. One factor is whether we can
arrange a sublicense or distribution  agreement related to patents for detection
of the HIV-2  virus.  HIV-2 is a type of the HIV virus  estimated to represent a
small  fraction  of the  known  HIV  cases  worldwide.  Nevertheless,  HIV-2  is
considered to be an important  component in the testing  regimen for HIV in many
markets.  Access to a license for one or more HIV-2  patents may be necessary to
sell HIV-2 tests in countries where such patents are in force, or to manufacture
in  countries  where  such  patents  are in force and then sell into  non-patent
markets.

Another  factor that may affect the specific  countries in which we will be able
to sell  our  rapid  HIV-1 or HIV-2  tests,  and  therefore  the  overall  sales
potential,  concerns  whether  we  can  arrange  a  sublicense  or  distribution
agreement  related to any patents  which claim  lateral  flow assay  methods and
devices covering the our rapid HIV tests or their use. Our  developmental  stage
tests are lateral flow assay devices that test for specific  antibodies or other
substances.  There are numerous patents in the United States and other countries
which claim  lateral flow assay  methods and devices.  Some of these patents may
broadly cover the technology used in our rapid test products and are in force in
the United  States and other  countries.  We may not be able to make or sell our
rapid test products in countries where these patents are in force.

In the event  that it is  determined  that a license is  required  and it is not
possible to negotiate a license agreement under a necessary patent,  our ability
to manufacture  and sell our rapid  products may be delayed or limited.  In such
case,  we may be able to modify our rapid tests such that a license would not be
necessary.  However,  this alternative may not be possible,  or, if feasible, it
could  delay or limit our ability to sell our rapid test  products,  which would
adversely affect our results of operations, cash flows and business.


                                      13



We Rely on Sole  Source  Suppliers  that We Cannot  Quickly  Replace for Certain
Components Critical to the Manufacture of Our Products.

Among the critical items we purchase from  qualified  sole source  suppliers are
various conjugates,  fetal bovine serum, and HIV-positive and HIV-negative urine
samples.  Any delay or  interruption in the supply of these or other sole source
components could have a material adverse effect on us by significantly impairing
our ability to manufacture products in sufficient quantities, particularly as we
increase  our  manufacturing  activities  in support  of  commercial  sales.  In
addition,  if our  financial  condition  reduces our ability to pay for critical
components on a timely basis,  our suppliers may delay or cease selling critical
components  to us,  which  could also  impair our  ability  to  manufacture.  We
typically do not have long-term supply agreements with these suppliers,  instead
using  purchase  orders to  arrange  for our  purchases  of  materials,  so that
suppliers  could delay or decline to ship  components  until  payment is made in
advance or on a COD basis.

We Have Limited  Experience in Manufacturing  Our Products and Little Experience
in Manufacturing Our Products In Commercial Quantities.

Turnover among our  manufacturing  personnel as a result of our consolidation of
the operations into our Rockville  facility has  necessitated  the hiring of new
manufacturing  personnel.  Such turnover has, in the past,  resulted in material
production difficulties including problems involving:

o    scaling up production of new products;

o    developing market acceptance for new product;

o    production yields;

o    quality control and assurance;

o    raw material supply; and

o    shortages of qualified personnel.

The current consolidation of manufacturing operations to our Rockville facility,
technology transfer and manufacturing  transitions and scale-ups in which we may
engage in the future could affect our ability to meet increases in demand should
our  products  gain market  acceptance  and could impede the growth of our sales
revenues.

In an Effort  to Scale Up Our  Manufacturing  Capacity  Quickly,  We May  Engage
Contract  Manufacturers  to Produce Some of Our  Products,  Including  Our Rapid
Tests Currently Under Development.

Outsourcing some of our  manufacturing  processes to contract  manufacturers may
permit us to expand our  manufacturing  capacity more  quickly,  but it may also
subject us to problems in such areas as:


o    lack of technical knowledge regarding regulated procedures;

o    uncertain or unreliable production yields;

o    maintaining quality control and assurance;

o    regulatory  compliance,  since most rapid test manufacturers do not produce
    products that are as stringently controlled as HIV diagnostics; and

o    Misappropriation   of  intellectual   property,   particularly  in  foreign
    countries where patent  protection is less stringent,  and depending on the
    extent of manufacturing processes that are outsourced.

The  Success  of Our Plans to Enter  International  Markets  May Be  Limited  or
Disrupted  Due to Risks  Related to  International  Trade and  Marketing and the
Capabilities of Our Distributors, Manufacturers and Joint Venture Partners.

Following the  anticipated  completion of the development of our rapid tests, we
believe that sales to  international  distributors  and/or joint  ventures  will
generate a significant  portion of our revenues for the next several  years.  We
believe  that our  urine and oral  fluid-based  tests  can  provide  significant
benefits in countries that do not have the facilities or personnel to safely and
effectively  collect and test blood  samples.  However,  sales to  international


                                      14



customers accounted for only 5% of our revenue in our fiscal year ended December
31,  2003 and less  than 1% of our  revenue  in the  first  quarter  of 2004.  A
majority  of the  companies  with which we compete in the sale of HIV  screening
tests actively market their diagnostic products outside of the U.S. In addition,
as regulatory requirements for HIV screening tests outside the United States are
less demanding than those of the FDA, we compete with our EIA products against a
much wider range of competitors that may not be FDA approved. Manufacturers from
Japan,  Canada,  Europe,  and Australia offer a number of HIV screening tests in
those markets  including  HIV-1/2  tests,  rapid tests and other non-EIA  format
tests,  which  are not  approved  for sale in the U.S.  market.  There can be no
assurance that our products will compete  effectively  against these products in
foreign markets, or that these competing products will not achieve FDA approval.
The following risks may limit or disrupt our international sales:

o    the imposition of government controls (regulatory approval);

o    export license requirements;

o    domestic license requirements;

o    political instability;

o    trade restrictions;

o    changes in tariffs;

o    difficulties   in  managing   international   operations   (difficulty   in
    establishing  a  relationship  with a foreign  distributor,  joint  venture
    partner, or contract manufacturer with the financial and logistical ability
    to maintain quality control of product);

o    the ability to secure licenses for intellectual property or technology that
    are  necessary  to  manufacture  or  sell  our  products  in  the  selected
    countries;

o    fluctuations in foreign currency exchanges rates;

o    the  financial  stability of our  distributors  and/or  their  expertise in
    obtaining local country regulatory approvals;

o    the  financial  capabilities  of potential  customers  in  lesser-developed
    countries or, alternatively,  our inability to obtain approvals which would
    enable such countries access to outside financing, such as the World Bank;

o    the ability of our distributors to successfully sell into their contractual
    market territory or to successfully cover their entire territory;

o    the  possibility   that  a  distributor  may  be  unable  to  meet  minimum
    contractual commitments;

o    establishing market awareness; and

o    external  conditions such as regional  conflicts or health crises resulting
    from SARS.

Some of our distributors have limited international marketing experience.  There
can be no assurance that these distributors will be able to successfully  market
our  products in foreign  markets.  Any such  failure  will delay or disrupt our
plans to expand the Company's business.

The Chinese  Government Could Change Its Policies Toward Private  Enterprises or
Even  Nationalize or Expropoiate  Them,  Which Could Result in the Total Loss of
Business in That Country.

We have established a joint venture in China and are currently  planning to sell
both our existing  products and our rapid products  currently under  development
through  it.  Our  business  in  China  is  subject  to  political  or  economic
uncertainties  and may be adversely  affected by political,  economic and social
developments in China. Over the past decade,  the Chinese government has pursued
economic  reform  policies,  including  the  encouragement  of private  economic
activity  and greater  economic  decentralization.  The Chinese  government  may
choose to end these policies or alter them  significantly  to our detriment with
little, if any, prior notice.

Changes in policies,  laws and  regulations  or in their  interpretation  or the
imposition of taxation,  restrictions  on currency  conversion,  restrictions or
devaluations  of currency,  nationalization  or other  expropriation  of private
enterprises  could  have a material  adverse  effect on our  business  in China.
Nationalization  or expropriation  could result in the total loss of business in
China.


                                      15



We Face Intense  Competition in the Medical Diagnostic Products Market and Rapid
Technological Advances by Competitors.

Competition  in our  diagnostic  market is intense and we expect it to increase.
The marketplace  where we sell our products is divided into two categories:  (i)
screening,  and  (ii)  supplemental  testing.  Within  the  United  States,  our
competitors   for  screening   tests   include  a  number  of   well-established
manufacturers of HIV tests using blood samples, plus at least one system for the
detection  of HIV  antibodies  using oral  fluid  samples.  In the  supplemental
testing category of the market, we offer the only FDA approved  urine-based test
as  well as a  blood-based  test.  One  other  company  offers  an FDA  approved
supplemental  blood test. In addition to our urine and blood-based  confirmation
test, there is also an oral mucosal transidate  (saliva) based supplemental test
to complement  the  oral-fluid  screening  test.  Many of our  competitors  have
significantly  greater financial,  marketing and distribution  resources than we
do. Our  competitors  may succeed in  developing or marketing  technologies  and
products  that are more  effective  than ours,  including  several  recently-FDA
approved rapid blood tests. In addition, as the anticipated acceptance for urine
testing  grows,  we may  experience  competition  from  companies in areas where
intellectual  property  rights  may  not be as  stringent  as in the  US.  These
developments   could   render  our   technologies   or   products   obsolete  or
noncompetitive  or  otherwise  affect our ability to  increase  or maintain  our
products' market share.

Our Research and  Development  of HIV Urine Tests Involves the Controlled Use of
Hazardous Materials.

There can be no assurance that the Company's safety  procedures for handling and
disposing  of  hazardous  materials  such as azide will comply  with  applicable
regulations.  For example,  azide, when present in high  concentrations  and not
diluted with water, can have an explosive reaction.  Azide is a chemical used as
a  preservative  in our  kits.  In  addition,  we cannot  eliminate  the risk of
accidental  contamination or injury from these materials.  We may be held liable
for  damages  from such an  accident  and that  liability  could have a material
adverse effect on the Company.

We May Not Be Able to Retain Our Key  Executives  and Research  and  Development
Personnel.

As a small  company,  our success  depends on the  services of key  employees in
executive and research and  development  positions.  The loss of the services of
one or more of such employees could have a material adverse effect on us.

As a Small  Manufacturer  of  Medical  Diagnostic  Products,  We Are  Exposed to
Product  Liability and Recall Risks For Which  Insurance  Coverage is Expensive,
Limited and Potentially Inadequate.

We  manufacture  medical  diagnostic  products,  which  subjects  us to risks of
product liability claims or product recalls,  particularly in the event of false
positive or false negative  reports.  A product  recall or a successful  product
liability  claim or claims  that  exceed  our  insurance  coverage  could have a
material  adverse effect on us. We maintain a $10,000,000  claims made policy of
product liability insurance.  However, product liability insurance is expensive.
In the future we may not be able to obtain  coverage on acceptable  terms, if at
all.  Moreover,  our  insurance  coverage  may not  adequately  protect  us from
liability  that we incur in  connection  with  clinical  trials  or sales of our
products.

Our Charter Documents May Inhibit a Takeover.

Certain provisions of our Certificate of Incorporation and Bylaws could:

o    discourage potential  acquisition  proposals (i.e.  shareholder rights plan
    also known as a "poison pill");

o    delay or prevent a change in control of Calypte;

o    diminish  stockholders'  opportunities  to participate in tender offers for
    our common stock,  including tender offers at prices above the then-current
    market price;

o    inhibit increases in the market price of our common stock that could result
    from takeover attempts; or

o    grant to the  Board  of  Directors  the  discretionary  right to  designate
    specific  rights and  preferences of preferred  stock greater than those of
    our common stock.

We Have  Adopted  a  Stockholder  Rights  Plan  That Has  Certain  Anti-takeover
Effects.


                                      16



On December  15, 1998,  the Board of  Directors  of Calypte  declared a dividend
distribution   of  one  preferred   share  purchase  right  ("Right")  for  each
outstanding  share of common stock of the  Company.  The dividend was payable to
the  stockholders  of record on  January  5, 1999 with  respect to each share of
common stock issued thereafter until a subsequent "distribution date" defined in
a Rights  Agreement  and, in certain  circumstances,  with  respect to shares of
common stock issued after the Distribution Date.

The Rights have certain anti-takeover effects. The Rights will cause substantial
dilution  to a person or group that  attempts  to acquire  the  Company  without
conditioning  the offer on the Rights being redeemed or a substantial  number of
Rights being acquired.  However, the Rights should not interfere with any tender
offer,  or merger,  which is approved  by the Company  because the Rights do not
become  exercisable  in the event of an offer or other  acquisition  exempted by
Calypte's Board of Directors.

Our Board of  Directors  has Certain  Discretionary  Rights With  Respect to Our
Preferred   Shares  That  May   Adversely   Effect  the  Rights  of  our  Common
Stockholders.

Our Board may, without shareholder  approval,  designate and issue our preferred
stock in one or more series.  Additionally,  our Board may  designate the rights
and  preferences  of each series of preferred  stock it designates  which may be
greater  than the rights of our common  stock.  Potential  effects on our common
stock may include among other things:

o    restricting dividends;

o    dilution of voting power;

o    impairment of liquidation rights; and

o    delay or preventing a change in control of the Company.

Additionally,  following  the 1:30 reverse split of our common stock that became
effective in May 2003, we currently have over 500 million shares of common stock
that could be issued without further stockholder approval. Although there are no
current  plans to issue such a large number of shares,  the  dilution  resulting
from such issuance could also adversely  affect the rights of our current common
stockholders.

             Risks Related to Regulatory Approvals and Clearances

The Time  Needed to Obtain  Regulatory  Approvals  and  Respond  to  Changes  in
Regulatory Requirements Could Adversely Affect Our Business.

Our  proposed and existing  products  are subject to  regulation  by the FDA and
other governmental or public health agencies.  In particular,  we are subject to
strict  governmental  controls  on  the  development,   manufacture,   labeling,
distribution and marketing of our products.  In addition,  we are often required
to obtain approval or registration with foreign governments or regulatory bodies
before we can import and sell our products in foreign countries.

The process of obtaining  required  approvals or clearances from governmental or
public  health  agencies can involve  lengthy and detailed  laboratory  testing,
human clinical  trials,  sampling  activities  and other costly,  time-consuming
procedures.  The  submission of an  application  to the FDA or other  regulatory
authority  does not guarantee  that an approval or clearance to market a product
will be received.  Each authority may impose its own  requirements  and delay or
refuse to grant  approval or clearance,  even though a product has been approved
in another country or by another agency.

Moreover, the approval or clearance process for a new product can be complex and
lengthy.  This time span  increases our costs to develop new products as well as
the risk that we will not succeed in  introducing  or selling them in the United
States or other countries.

Newly  promulgated  or  changed  regulations  could  also  require us to undergo
additional trials or procedures,  or could make it impractical or impossible for
us to market our products for certain uses, in certain markets, or at all.


                                      17




Failure to Comply With FDA or Similar  International  Regulatory Bodies or Other
Requirements  May Require Us to Suspend  Production of Our Products  Which Could
Result in a Loss of Revenues.

We can manufacture and sell products, both in the United States and abroad, only
if we comply with  regulations  of government  agencies such as the FDA. We have
implemented quality assurance and other systems that are intended to comply with
applicable regulations in the United States.

Although  we  believe  that  we have  adequate  processes  in  place  to  ensure
compliance with these requirements, the FDA could force us to stop manufacturing
our  products if it  concludes  that we are out of  compliance  with  applicable
regulations.  The FDA could  also  require us to recall  products  if we fail to
comply with applicable  regulations,  which could force us to stop manufacturing
such  products.  We will face similar risks when we establish our  international
manufacturing operations.