FDA Clears Genomic Test for Thrombosis

Personalized medicine on the move again, one more test with DNA to check for inherited thrombosis. BD

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.