American Association for Clinical Chemistry
Better health through laboratory medicine
July 2008 Clinical Laboratory News: News from the FDA

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July 2008: Volume 34, Number 7


ParagonDx Gets Clearance for Warfarin Sensitivity Genotyping Kit


ParagonDx announced FDA clearance for its rapid genotyping assay that detects the presence of variations in the genes CYP2C9 and VKORC1, information physicians can use to identify patients who are at greater risk for warfarin sensitivity. The test can be completed within 1-hour and was FDA cleared using the Cepheid SmartCycler Dx platform.


FDA Clears Invitrogen Transplant Compatibility Test System


Invitrogen announced FDA clearance for its DynaChip Antibody Analysis System, the only automated chip-based system for HLA antibody detection and identification. Providing fully integrated instrumentation, reagents, and software, the system is composed of a processor for automated assay processing, a protein array that allows testing of multiple antibodies at the same time, and interpretation software for automated analysis.


AMBC’s Rapid TOX Cup Cleared


American Bio Medica announced FDA clearance of its Rapid TOX Cup drug screen system, an all-inclusive DOA cup platform. Available with multiple assay combinations according to customer requirements, the Rapid TOX Cup does not require any manipulation of the device and includes a temperature strip affixed to the cup to ensure specimen integrity. Results can be photocopied for recordkeeping, and the all-in-one design allows collection, testing, and shipment for confirmation.


FDA Drops Backup Testing Requirement for Prodesse’s ProFlu+


Prodesse announced that the FDA okayed changing the package insert for the ProFlu+ molecular respiratory viruses test to remove the recommendation that negative results for flu A and B be confirmed by culture. The agency first cleared the test in January. So far this is the only molecular test for respiratory viruses for which the FDA has decided that no backup testing is needed. The FDA also allowed Prodesse to add the bioMérieux NucliSENS easyMAG automated nucleic acid extraction system as an acceptable extraction method for the ProFlu+ test.


FDA Clears Access Toxo IgG Assay


Beckman Coulter announced the clearance of its Access Toxo IgG assay, a paramagnetic-particle, chemiluminescent immunoassay for the quantitative and qualitative determination of IgG antibodies to Toxoplasma gondii in human serum using the company’s Access immunoassay instruments. The test is cleared as an aid in the diagnosis of Toxoplasma gondii infection and may be used to assess the immune status of pregnant women. It’s not cleared for screening blood or plasma donors in the U.S.