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Calypte Biomedical Submits Investigational Device Exemption Application for HIV-1 Rapid Blood Test
ALAMEDA, Calif., Nov. 6 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CYPT), the developer and marketer of the only two FDA approved HIV-1 antibody tests for use with urine samples, announced today that it is submitting an application with the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) for its HIV-1 lateral flow antibody Rapid Blood Test to be performed on whole blood. This represents the Company's first application in connection with several rapid HIV diagnostic tests the Company has under development. The Company expects to submit a similar application for its urine-based HIV-1 Rapid Test sometime next year.
"This application represents an important step in our attempt to penetrate the U.S. market for our suite of Rapid Test products," said Tony Cataldo, Calypte Biomedical's Chairman. "While we believe that near-term international opportunities for our Urine-based Rapid Test (once approved/commercially viable) will drive revenue growth, ultimately we feel that the North American market will represent a potential for substantial commercial opportunity for our Urine-based Rapid Test. We believe our ability to market a blood-based Rapid Test product will raise awareness among the U.S. medical community for our suite of Rapid Test products and ultimately shorten the sales cycle for our urine-based HIV product. In addition, we anticipate that there will be opportunities to cross-sell our blood related testing products to the medical community, as it acts as an excellent confirmatory test for urine."
Under federal regulations, the FDA can authorize the use of an investigational test in the treatment of patients with serious or life-threatening conditions when no comparable or satisfactory alternative exists. The Company believes that its HIV-1 Rapid Blood Test may be cheaper than similar products currently being marketed in the U.S.
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