American Association for Clinical Chemistry
Better health through laboratory medicine
February 2011 Clinical Laboratory News: News from the FDA

News from the FDA

Gen-Probe’s Human Adenovirus Test Cleared

FDA has cleared Gen-Probe’s Prodesse ProAdeno + assay for market. Designed for the qualitative detection of human adenovirus, the test uses real-time polymerase chain reaction to detect human adenovirus DNA in nasopharyngeal specimens obtained from individuals showing signs and symptoms of acute respiratory infection.

Celera Submits KIF6 Test for FDA Approval

Celera Corporation has filed for FDA approval to market its KIF6 Genotyping Assay, a new molecular in vitro diagnostic (IVD) test designed to detect a coronary heart disease risk marker. Celera submitted the premarket approval application for the test to operate on Abbott’s m2000 molecular diagnostics instrument system. The company’s Berkeley HeartLab business currently offers a KIF6 test in the U.S. as a laboratory-developed test.

Extended Shelf Life Approved for OraSure’s HIV Test

OraSure Technologies has received FDA approval to extend the shelf life of its OraQuick HIV test from 18 to 24 months. The company said the move followed improved production of the product, which detects HIV in oral fluid and blood samples.