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NYDOH Approves AltheaDx's PGx Test Suite

NEW YORK (GenomeWeb) – AltheaDx's suite of pharmacogenetic tests, called IDgenetix, has been approved by the New York Department of Health, enabling the molecular diagnostics firm to sell the tests in all 50 US states.

AltheaDx performs all its tests out of its CLIA-certified San Diego laboratory, which in July also received accreditation from the College of American Pathologists.

The firm's IDgenetix tests gauge variations in CYP450 genes and determine whether patients are extensive, poor, intermediate, or ultra-rapid metabolizers. The tests produce a color-coded report for doctors indicating which drugs can be "used as directed" and which require caution or increased monitoring. The report also provides gene-specific results to the doctor to help them with therapeutic decisions for a number of cardiology, psychiatry, and pain management conditions.

The NYSDOH has one of the highest bars among state health departments for ensuring the safety and efficacy CLIA lab tests. During the review process, the NYSDOH looked over AltheaDx's test validation data, requisition forms, reports, as well as lab procedures and manuals. "The process also included an on-site inspection of the AltheaDx laboratory, which was completed with no deficiencies," the company said.