Originally Published IVD Technology
March 2004
INDUSTRY NEWS
NotableFDA cleared a test kit to be used along with culture-based testing for Bacillus anthracis (anthrax). The approved assay, the Redline Alert test by
Tetracore (Gaithersburg, MD), can be performed in 15 minutes, as compared with other FDA-approved tests that must be run overnight. Although a positive result means that it is likely that the test subject has been infected with anthrax, a negative result cannot rule out anthrax. FDA recommends that backup, confirmatory testing be performed alongside the Redline Alert test.
FDA also approved two tests for blood clotting abnormalities. These are the first FDA-approved DNA-based laboratory tests for an inherited disorder. The test kits, the Factor V Leiden kit and Factor II (prothrombin) G20210A kit, are manufactured by Roche Diagnostics (Indianapolis). The tests will be used to identify the Factor V Leiden or Factor II genetic abnormality in patients with a personal or family history of abnormal blood clots.
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