State Nod Marks Another Win for ‘Precision Medication’

An accomplished Long Island biotech with a penchant for polymerase chain reaction-based DNA technologies has earned state approvals for a cutting-edge pharmacogenomic testing service.

Pharmacogenomics, the study of how a person’s unique genes affect his or her individual response to drugs, is at the heart of personalized therapeutics, which eschews one-size-fits-all treatments and, according to some scientists, represents a path to healthcare’s most effective future.

Among the innovators traveling that path is Stony Brook-based Applied DNA Sciences, with a nod to the New York State Department of Health.

The Health Department has approved Applied DNA’s TR8 PGx pharmacogenomic testing service, which is designed to analyze 120 genetic variants across 30-plus genes to inform healthcare providers how a patient might respond to a wide range of medications – common drugs, groundbreaking experimental pharmaceuticals and other treatments for a wide variety of conditions.

Working off a simple cheek swab, the noninvasive technology aims to give healthcare providers more personalized details about a patient’s likely response to a particular prescription, avoiding new problems and improving healthcare efficacy across the board.

Counting New York Department of Health standards among “the most rigorous in the country,” Applied DNA Sciences President and CEO James Hayward applauded a big win for pharmacogenomics in general and “a significant regulatory milestone for [our] company.”

“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,” Hayward said June 13.

Wasting little time on that promise, Applied DNA announced June 18 that Applied DNA Clinical Labs, the mothership’s molecular diagnostics-focused subsidiary, had reached an agreement with Canadian health-tech developer GenXys Health Care Systems to use GenXys’ proprietary suite of clinical-decision support software for “interpretation and reporting” of TR8 PGx testing.

“We believe that GenXys offers best-in-class PGx clinical integration services,” Hayward noted in the partnership announcement. “We are excited to partner with GenXys as our go-to-market partner for our TR8 PGx test.”

With multiple studies suggesting that PGx-guided “precision prescribing” can improve patient compliance and pharmaceutical outcomes while cutting down adverse reactions and rehospitalizations, the TR8 PGx field trials – which will focus exclusively on patients in New York State, with upwards of 180 tests performed per day – mark a huge advance toward a healthier future for patients suffering from cardiovascular, oncology, psychiatric and other conditions, according to Hayward.

“Launching this testing service delivers on our commitment to advance personalized medicine through cost-effective and scalable genetic testing for improved patient outcomes and reduced healthcare costs,” the CEO added. “We are pleased to bring to New Yorkers PGx testing, which we believe holds the enormous potential to help them live their healthiest lives.”