=84 Biopool International Inc., of Ventura, Calif., received FDA 510(k)=20clearance to market the Chromolize tPA Assay Kit, which measures=20the level of tissue plasminogen activator in blood. Measurements of=20tPA correlate with the ability to break down blood clots.
=84 Calypte Biomedical Corp., of Berkeley, Calif., received FDA=20approval to market its diagnostic test for detecting antibodies to HIV-1 in urine. The product is named Calypte HIV-1 Urine EIA or=20Sentinel HIV-1 Urine EIA. It is the first urine-based test for detecting =
=84 Cytogen Corp., of Princeton, N.J., signed a definitive agreement=20with C.R. Bard Inc., of Murray Hill, N.J., for ProstaScint, a=20monoclonal antibody labeled with indium-111 for diagnosing=20prostate cancer. The initial agreement is for 10 years. An FDA=20advisory committee recommended approval of ProstaScint for use, in=20conjunction with other diagnostic information, in patients for whom=20there is a high suspicion of occult metastatic disease.
=84 Igen Inc., of Gaithersburg, Md., and partner Boehringer Mannheim,=20of Mannheim, Germany, received FDA clearance for the Elecsys=202010 System, the first in a series of systems for the=20immunodiagnostics market. Immunoassays offered with the initial=20test menu include those for use in endocrinology and cardiac=20assessments, as well as for diagnosis of anemic and cancerous=20conditions. Mannheim has introduced the product to the European=20clinical research market. U.S. launch is expected in the fourth=20quarter.
=84 Trinity Biotech plc, of Dublin, Ireland, launched new one-step tests =
for HIV and hepatitis B. The diagnostics _ called Uni-Gold HIV and=20Uni-Gold Hepatitis B _ require only a drop of whole blood, serum or=20plasma to determine the HIV or hepatitis B status of a patient.
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