BD Receives Clearance and CLIA Waiver for Influenza Test
Becton Dickinson received FDA clearance and a CLIA waiver for its new Veritor System for rapid detection of influenza A+B. The test system, which combines BD's nano detection particle and adaptive read technology, includes a digital read out of results and reports performance measured against polymerase chain reaction results.
Herceptin Test Approved
FDA approved Dako's companion diagnostic test for determining which breast cancer patients may benefit from treatment with Herceptin (trastuzumab). The firm's HER2 CISH pharmDx Kit measures copies of the HER2 gene in formalin-fixed, paraffin-embedded breast cancer tissue specimens using a chromogenic in situ method.
Meridian Bio's C. difficile Test Cleared
Meridian Bioscience received FDA clearance to market its Clostridium difficile assay. The ImmunoCard C. difficile GDH assay detects the C. difficile common antigen glutamate dehyrogenase, which is present in both toxigenic and non-toxigenic strains of the bacteria. The test can be used to identify patients suspected of being infected with the bacterium.
Staphylococcus Test Gets Nod
FDA cleared Nanosphere's Verigene Staphylococcus Blood Culture Nucleic Acid Test for market. The BC-S test is designed to detect Staphylococcus aureus, Staphylococcus epidermis, and the mecA gene, which confers resistance to the antibiotic methycillin/oxacillin. The test provides species and resistance detection from two types of gram-positive blood culture bottles in 2.5 hours, helping to guide appropriate antibiotic therapy for patients.
Clearance for Quidel's MDx Assays
Quidel received FDA clearance to market two of its molecular tests, one for detection of human metapneumovirus and the other for influenza A and B. The Quidel Molecular hMPV Assay and the Quidel Molecular Influenza A+B Assay are polymerase chain reaction-based tests designed to be used with the Applied Biosystems 7500 Fast DX thermocycler.