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FDA Clears Illumina's Tests for Thrombosis

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Illumina said after the close of the market Tuesday that it has received 510(k) clearance from the US Food and Drug Administration for its VeraCode Genotyping Test for Factor V mutation (Leiden) and Factor II mutation (prothrombin).

The test is comprised of Illumina's VeraCode digital microbead technology, which it acquired through the purchase of CyVera in 2004, as well as proprietary assay chemistry. The VeraCode technology is the basis for Illumina's BeadXpress system, a platform for research and clinical development applications.

The BeadXpress system is FDA-approved for in vitro diagnostic use only with the VeraCode Genotyping Test for Factor V and Factor II. Factor V is the most common genetic defect for inherited thrombosis, and Factor II is the second-most common. Two weeks ago, Illumina receive a separate clearance from FDA for the BeadXpress system.

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