CALY. FDA approval today. ALAMEDA, Calif.--(BUSINESS WIRE)--November 18, 1999--
New Indication Provides Same-Day Results
Calypte Biomedical Corporation (Nasdaq: CALY) announced today that the U.S. Food and Drug Administration (FDA) approved a "Day Assay" license supplement to its "Cambridge Biotech" Human Immunodeficiency Virus Type 1 (HIV-1) Western Blot test that confirms the presence of antibodies to HIV-1 in serum samples. The approval of the "Day Assay" format supplement means that Calypte Biomedical's "Cambridge Biotech" HIV-1 Western Blot assay can now be used in either a "Day Assay" (5-hour) format or the existing "overnight" format.
"The FDA approval of Calypte's HIV-1 serum supplemental test is a victory for customers who want to obtain the results of their HIV tests as soon as possible," said Nancy Katz, President and COO of Calypte. "Calypte's Western Blot HIV-1 supplemental test is the premier serum-based confirmatory test on the market today. With today's approval of this time-saving assay, we are enhancing our goal of addressing the spread of HIV infection by providing a faster, accurate testing alternative."
"We believe that today's approval will enhance the demand for Calypte's serum-based HIV screening tests," Ms. Katz continued. "By providing patients with flexible testing options and diagnostic schedules, we will enable our primary customers - diagnostic and blood screening laboratories - to better meet the needs of their patients."
In September 1999, Carter-Wallace, Inc. (NYSE: CAR) signed a definitive distribution agreement to have exclusive U.S. sales and marketing rights for Calypte's urine HIV testing products in the hospital, public health and reference lab markets, and co-exclusive rights for the serum-based testing products. Carter-Wallace distributes Calypte's three FDA-approved products, which include: 1) the urine HIV-1 screening test; 2) the urine HIV-1 supplemental Western Blot test; and, 3) the serum HIV-1 supplemental Western Blot test.
In August 1999, Calypte announced that it had signed agreements with four distributors to distribute its urine HIV-1 screening EIA and Western Blot supplemental tests to 13 countries throughout the Middle East, Eastern Europe and Asia.
Calypte Biomedical is a manufacturer of HIV-related diagnostic tests. These tests include a serum Western Blot supplemental test and the only two FDA-licensed HIV-1 antibody tests that can be used on urine samples. Urine testing is non-invasive, less costly and does not require sample storage. In addition, a trained health care worker is not needed for sample collection and urine testing is safer than blood tests because it avoids risks of accidental needle sticks.
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding market adoption of the HIV-1 urine testing system and the serum Western Blot test and statements regarding marketing and distribution arrangements and plans. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including the Company's ability, directly or through third parties, to successfully manufacture and market the HIV-1 urine testing system and the serum Western Blot test and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect the occurrence of unanticipated events. Factors which may impact the Company's success are more fully discussed in the Company's most recent periodic reports on Forms 10-K and 10-Q.
CONTACT:
Nancy Katz, President
510-749-5100
-or-
ave Collins, CEO
510-749-5100
KEYWORD: CALIFORNIA
BW1172 NOV 18,1999
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