Logo

AutoGenomics Files Infiniti Warfarin-Metabolism Assay With FDA for 510(k) Clearance

Dec 11, 2006
NEW YORK (GenomeWeb News) — AutoGenomics today said it has filed one of its Infiniti assays with the US Food and Drug Administration for 510(k) pre-market review.
 
AGI said it expects to receive 510(k) approval around the middle of 2007. Until that approval comes through, the company said, customers may use a self-validation process.
 
The assay is designed to spot genetic variants of an enzyme linked to the therapeutic use of the common anti-coagulant warfarin.
 
The company said it has finished a multi-center clinical study of how genetic variations within the enzyme CYP450 2C9/VKORC1 can affect a person’s ability to metabolize warfarin.
 
The company said it submitted the assay in October 2006.

Breaking News
The Scan

Purnell Choppin Dies

Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.

Effectiveness May Decline, Data From Israel Suggests

The New York Times reports that new Israeli data suggests a decline in Pfizer-BioNTech SARS-CoV-2 vaccine effectiveness against Delta variant infection, though protection against severe disease remains high.

To See Future Risk

Slate looks into the use of polygenic risk scores in embryo screening.

PLOS Papers on Methicillin-Resistant Staphylococcus, Bone Marrow Smear Sequencing, More

In PLOS this week: genomic analysis of methicillin-resistant Staphylococcus pseudintermedius, archived bone marrow sequencing, and more.