Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.