NEW YORK – Applied DNA Sciences on Thursday said that the New York State Department of Health has approved its TR8 PGx pharmacogenomic testing service.
Applied DNA's clinical laboratory subsidiary, Applied DNA Clinical Labs, will launch the PGx testing service to guide healthcare providers prescribing cardiovascular, oncology, psychiatric, infectious disease, and pain management medications informed by genetics. The TR8 test, based on a cheek swab sample, analyzes 120 genetic targets across more than 30 genes.
The service will be available by prescription and initially target patients in New York state.
Stony Brook, New York-based Applied DNA is in discussions to provide the PGx testing services to enterprise customers, healthcare networks, and concierge physician practices.
"We believe New York State is a greenfield market for PGx testing, and we are actively recruiting testing volume through partnerships with employers, healthcare systems, and large-scale enterprises to establish market share," Applied DNA President and CEO James Hayward said in a statement.
Applied DNA Clinical Labs is a CLIA-certified clinical laboratory. TR8 is a laboratory-developed test and has not been cleared by the US Food and Drug Administration.