...vom user NewKidOnTheBlog
Die letzte Volition PM ist ein Knaller http://ir.volitionrx.com/press-releases/detail/582/data-pres
NAMUR, Belgium, Oct. 11, 2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced that research presented at the European Society for Medical Oncology Congress (ESMO) shows that Volition's novel blood test for colorectal cancer combined with the conventional faecal immunochemical screening test has the potential to offer up to a 25% reduction in colonoscopies while maintaining almost 97% detection of colorectal cancer when combined with the faecal immunochemical test (FIT) score. Dr. Marielle Herzog, Volition's lead scientist for Nucleosomics®, presented a poster on the results from the first 2000 of the (1)8000 FIT positive patients in this study. This prospective screening study, conducted in conjunction with Hvidovre Hospital, University of Copenhagen, aims to discover the ability of the Nu.QTM Colorectal Cancer Screening Triage Test (blood test) to (2) identify patients with a false positive on their FIT, in order to reduce the total number of colonoscopy referrals. (3) Less than 10% of people with a positive FIT score have colorectal cancer; a positive FIT score is not a diagnostic for cancer but means simply that blood has been found in the stool. This means that there are a significant number of unnecessary, expensive and invasive colonoscopies performed, placing a burden on both the patient and healthcare system. The combination of FIT test and the Nu.QTM Triage Test in the study identified nearly 97% of colorectal cancers in FIT positive subjects. By utilizing this regimen, screening programs could reduce the number of unnecessary colonoscopies performed and more importantly, for the same number of colonoscopies potentially increase screening subject throughput by up to 33%, which could result in a net increase in total CRC cases detected by up to 29%. Please note that the Poster and Presentation from ESMO are available in the Technology section of the Volition website. Currently in Denmark, around 20,000 people have a positive faecal test for colorectal cancer each year. All of them are referred for a colonoscopy, however, statistics demonstrate that only approximately 1,000 of them have cancer and require urgent diagnosis. The lead author of the study, Dr. Marielle Herzog, commented: (4) "False positives add to an already long waiting list and delays diagnosis for patients who have cancer and need swift treatment. By undertaking this simple, cost effective blood test in people with a positive faecal test, we can help prevent unneeded referrals for colonoscopy with a small reduction in cancer detection and potentially reduce the colonoscopy waiting time for those at high risk of cancer." (5) Volition plans initially to focus the launch of its Nu.QTM Colorectal Cancer Screening Triage Test in the EU member states, which have an aggregate screening age population of approximately 148 million patients. There are organized colorectal cancer screening programs in 14 of the 28 EU states with a further 10 states offering some form of public or privately accessible screening. Louise Day, Chief Marketing and Communications Officer said, "The introduction of Nu.QTM to help physicians decide whether patients need to go on to have a colonoscopy has the potential to significantly alleviate some of the capacity pressures within healthcare systems. Our hope is that more people will be able to be screened and more colorectal cancer cases identified early. The poster presented at ESMO this week has generated a lot of interest and discussion. We expect to receive CE Marking for this test later this year and aim to market it throughout Europe in 2017." Meine Kommentare zu den Filetstuecken ! (1) 8000 FIT Positiven in einer prospektiven Studie in Denmark. Wenn man eine FIT Spezifizitaet von 95% in der Durschnittsrisiko Bevoelkerung annimmt (das ist sogar die Untergrenze) heisst das, dass mindestens 160 000 Personen den Test gemacht haben. Wenn man sich den Original Poster durchliest erfaehrt man, dass die FIT Positiven alle aus dem daenischen Screening Progam stammen. Von den 8000 liegen aktuell 1907 komplette Daten vor, sprich sind anschliessend zur Darmspiegelung gegangen. (2) identify patients with a false positive on their FIT, in order to reduce the total number of colonoscopy referrals. Damit wird zum esten mal deutlich was man mit dieser Studie ueberhaupt beabsichtigt: man will weniger Darmspiegelungen durchfuehren !!!!! (3) Less than 10% of people with a positive FIT score have colorectal cancer Unter der 1907 Darmspiegelungen gab's 118 Krebsfaelle und 989 Adenome, darunter waren wiedrum 252 Adenome mit erhoeten Risiko (high risk adenome). Die uebrigen 800 waren komplett symptomfrei. Bei insgesamt 1107 sprich knapp 60% hat es sich also gelohnt die Darmspieglung durchzufuehren. Die angegebene 10% ist kliniisch gesehen schlicht und ergreiffend irrefuehrend und fahrlaessig. (4) False positives add to an already long waiting list. Da haben wir die Erklaerung: es gibt in Daenemark nicht genug Darmspiegelungen Kapazitaeten um die sehr ueberschaubaren 3 bis 5% FIT Falschpositiven zuegig zu bahandeln (5) Volition plans initially to focus the launch of its Nu.QTM Colorectal Cancer Screening Triage Test in the EU member states. Ist ja klar ! Da es von diesem Test immer noch keine soliden Performance Daten in einer echten prospektiven Screening Kohorte gibt (Spaezifizitaet geschaetzt auf unter 80% bei einer vergleichbaren Sensitivitaet wie EpiProColon), ist es unvorstellbar den Test in den USA zu vermarkten. Ein Triage Test fuer den die Zielgruppe die FIT positiven sind ? Das ist ja vielleicht in Europa vorstellbar (Prioritaet= weniger Kosten) aber in USA ? Das Ziel ist die Screening Rate zu erhoehen, also mehr Leute zum Screening zu motivieren !!! Im direkten Vergleich in den USA: EpiProColon: PMA Zulassung und Marktpotential =33% der Bevoelkerung 50 und darueber, sprich knapp 30mio US Amerikaner Volition: keine US prospektive Studie in der Zielgruppe (Zeit und Geld wie wir wissen), Marktpotential = 5% der 10m jaehrlich durchgefuehrten US FIT Tests, sprich 0,5mio Amerikaner also weniger als 2% vom potentiellen Epi Markt Und das Ding hat eine MK von USD 118m verglichen mit EUR 108m fuer Epi. Ich lach mich tot !
EPIGENOMICS N Helden | wallstreet-online.de - Vollständige Diskussion unter:
http://www.wallstreet-online.de/diskussion/...50/epigenomics-n-helden |
Thread abonnieren
