Admera Health Receives CLEP Approval for Pharmacogenomics Test
News Nov 10, 2016
Admera Health has announced that it has received New York State Clinical Laboratory Evaluation Program (CLEP) approval for its 25 gene PGxOne™ Plus pharmacogenomics (PGx) test. “This approval is a major milestone for Admera and exemplifies our aptitude to deliver molecular diagnostics that meet the highest quality standards,” said Guanghui Hu, PhD, President and CEO of Admera Health.
“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.”
PGxOne™ Plus leverages Next Generation Sequencing (NGS) technology to interrogate 25 genes with associated PGx information. Test results help predict how patients will respond to drug therapy for several therapeutic areas including, but not limited to, cardiology, psychiatry, pain management, and oncology.
Examples of recommendations provided in the report are: consider alternatives when specific drugs should be avoided, adjust dose, use with caution, or normal response expected. Recently, Admera updated the PGxOne™ Plus panel to include an additional 25 genes, bringing the number of drugs whose metabolism is affected to over 220.
Dr. Hu went on to elaborate, “This is our first step in providing NGS-based molecular diagnostics solutions in New York. We are forging ahead with plans to have our recently updated 50 gene PGxOne™ Plus panel available there, making it available in all 50 states.” In addition to PGx testing, Admera Health offers clinical testing for the risk assessment and diagnosis of inherited cardiovascular diseases and cancer tumor profiling to guide selection of targeted therapies.
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