Skip to main content
Premium Trial:

Request an Annual Quote

AutoGenomics Gets FDA OK for Warfarin MDx Assay

NEW YORK (GenomeWeb News) – AutoGenomics today announced that it has received US Food and Drug Administration clearance to market its Infiniti 2C9-VKORC1 Multiplex Assay for warfarin sensitivity.
 
The Carlsbad, Calif.-based firm becomes the second firm to gain FDA clearance for a molecular-based assay for warfarin. In September, the agency approved Nanosphere’s Verigene Warfarin Metabolism Nucleic Acid Test, which runs on that company’s Verigene platform.
 
Autogenomics received FDA clearance last May for its Infiniti Analyzer as a stand-alone instrument for multiplexed assays. The firm also holds FDA clearance for its Infiniti Factor II and Factor V assays for diagnosing thrombophilia.
 
In August, FDA updated labeling for warfarin with information explaining that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug.
 
The agency, however, stopped short of requiring physicians in the label to genetically test their patients, noting that additional outcomes studies needed to be done.
 
 

The Scan

Shape of Them All

According to BBC News, researchers have developed a protein structure database that includes much of the human proteome.

For Flu and More

The Wall Street Journal reports that several vaccine developers are working on mRNA-based vaccines for influenza.

To Boost Women

China's Ministry of Science and Technology aims to boost the number of female researchers through a new policy, reports the South China Morning Post.

Science Papers Describe Approach to Predict Chemotherapeutic Response, Role of Transcriptional Noise

In Science this week: neural network to predict chemotherapeutic response in cancer patients, and more.