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The FDA "Review Complete" letter indicated that the application is approvable pending the completion of product labeling.
The Urine HIV-1 Western Blot is a urine confirmation test manufactured in Rockville, Md., by Cambridge Biotech Corp., a wholly owned subsidiary of bioMerieux Vitek Inc. (St. Louis, Mo.) under a license from Calypte. Cambridge Biotech became the first company to produce an FDA-licensed confirmation test for blood samples over a decade ago.
The FDA's "Review Complete" announcement for the Urine HIV-1 confirmation test will permit the test to be marketed as soon as the product's labeling is finalized. "We are working closely with the FDA to complete the process as quickly as possible," said Rebecca Leaper, Vice President of Operations at Cambridge Biotech.
As with blood samples, urine HIV testing in the U.S. requires two levels of testing: the first level is performed with the Calypte HIV-1 Urine EIA screening test for HIV antibodies. Those specimens which are repeatedly reactive in the Calypte HIV-1 Urine screening test must then be tested with a confirmation test.
"While we can't be certain about timing of final product approval, we believe that this decision by the FDA signals that a safer more cost-effective way of testing for HIV-1 should soon become widely accessible," said Jack Davis, president and CEO of Calypte Biomedical Corp.
"We expect that many people who have declined blood HIV tests in the past will come forward for testing and counseling now that it can be done so painlessly and conveniently. More widespread and earlier testing, combined with more timely treatment of those found to be HIV-infected, can have a significant beneficial impact in reducing the spread and increasing the disease-free period of this disease," Davis said.
Seradyn Inc. (Indianapolis) is the U.S. distributor for Calypte's HIV-1 Urine screening test, which is marketed under the tradename Sentinel(TM). Seradyn will also be a distributor for the Cambridge HIV-1 Urine confirmation test.
The HIV-1 Urine testing system has a high level of accuracy and urine is easier and safer to collect than blood. The urine of HIV-infected people, like their blood, contains the antibodies to HIV which are a response to infection, but unlike blood, urine does not appear to harbor the infectious virus itself.
"We believe that urine sampling is an attractive option to blood sampling in many medical settings, including STD Clinics, anonymous HIV Clinics, hospitals, and doctors' offices. We have also received keen interest in the Urine HIV test from institutional testing sites, such as prisons," said Dwaine Ogden, vice president of sales and marketing for Seradyn. "The availability of a Urine HIV-1 confirmation test, once approved, will make the urine sampling option all the more attractive, and we anticipate a major surge of interest as a result."
Calypte Biomedical Corp. is an Alameda, Calif.-based health care company dedicated to the development and commercialization of urine-based diagnostic products and services for HIV-1, sexually transmitted diseases and other chronic illnesses.
This release contains forward-looking statements relating to Calypte Biomedical and the Calypte Urine test for HIV-1. These forward-looking statements contain risks and uncertainties, which could cause actual results to differ materially from those projected. These and other risks relating to Calypte Biomedical are set forth in "Risk Factors" in the company's prospectus filed with the Securities and Exchange Commission on July 29, 1996, as supplemented on Aug. 7, 1996.
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CONTACT: Calypte Biomedical Corp. Jack Davis, 510/814-8500 (President/CEO) John DiPietro, 510/814-8500 (CFO) or Seradyn Inc. Dwaine Ogden, 317/266-2935 or Cambridge Biotech Corp. Rebecca Leaper, 301/251-0800 (VP Operations) Brian Armstrong, 314/731-8500 (VP Finance)
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