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Calypte Receives FDA Approvals on Revised Labeling for Urine Screeningand Supplemental Tests; Provides Opportunity for Increased MarketingOpportunities
ALAMEDA, Calif., May 23, 2003 (BUSINESS WIRE) -- Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA approved serum HIV-1 antibody Western blot supplemental test, announced that it has received several recent FDA approvals for revisions to the product labeling for its Calypte HIV-1 Urine EIA screening test and its Cambridge Biotech HIV-1 Urine Western Blot supplemental test. These two products are used in the current FDA-accepted HIV testing algorithm where a reactive screening test result is followed up with a supplemental assay for confirmation of the screening result.
"When the HIV-1 Urine EIA screening test was approved by FDA in 1996, there was no approved urine supplemental test," said Don Kafader, Calypte Biomedical`s Director of Regulatory Affairs. "As a result, certain limitations were noted in the product`s package insert. Many of these limitations remained in place after the subsequent 1998 FDA approval allowing urine samples to be tested with the Cambridge Biotech HIV-1 Western Blot.
"Now that urine HIV testing has been around for several years, the medical and laboratory professions and the FDA are more comfortable with the technology and with the performance of the overall urine testing algorithm. These recent FDA approvals now allow us to remove many of the limitations and restrictions imposed at the time of the original approvals."
The company is currently in the process of implementing the new product package inserts, the Subject Information Brochure and other associated labeling materials. "We believe that the FDA`s action is very significant in that it should facilitate our ability to market our tests to clinics and testing centers throughout the U.S.," stated Nancy Katz, Calypte`s President and Chief Executive Officer. "It has been one of our continuing goals to provide products that allow more people to be tested in easier, less painful ways. FDA`s recent approvals to revise our product labeling to encourage broader use of our products facilitates our ability to accomplish this critical goal."
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