NEW YORK (GenomeWeb) – Molecular diagnostics firm Admera Health announced today that it has received approval from the New York State Clinical Laboratory Evaluation Program for its 50-gene PGxOne Plus pharmacogenomics test.
PGxOne Plus uses next-generation sequencing technology to interrogate genes with the aim of predicting how patients will respond to drug therapy in cardiology, psychiatry, pain management, and oncology, among other areas. Reports sent to clinicians include information on whether specific drugs should be avoided, alternative treatments, and dosage adjustments.
The panel originally interrogated 25 genes, but Admera said it recently updated the assay to include an additional 25 genes, bringing the number of drugs it considers to more than 220.
"This approval is a major milestone for Admera and exemplifies our aptitude to deliver molecular diagnostics that meet the highest quality standards," said Admera President and CEO Guanghui Hu in a statement. "We are pleased to be able to offer New York residents clinical PGx testing. Results can guide effective treatment decisions, potentially reducing adverse drug events and trial-and-error drug selection and dosing. Furthermore, our report provides valuable information about harmful drug-drug, drug-food, drug-alcohol and drug-laboratory test interactions."
The company has plans to seek approval for the test in all 50 states, Hu added.
In March 2015, Admera received approval from the New Jersey Department of Health for use of the PGxOne Plus in the clinic.