NEW YORK – Solvd Health said last week that it has received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) for its San Diego-based laboratory.
The approval allows the lab to offer to run its AvertD test, a pharmacogenomic assay intended to help guide the prescription of opioid medications, for residents of New York. The test targets 15 common genetic alterations that may be linked to a patient's susceptibility to opioid use disorder.
New York state maintains stricter standards for laboratory-developed tests than many other US states, requiring more rigorous validation data.
"Securing New York state approval is a pivotal step in our mission to expand access to genetic testing that can help address the opioid crisis," Solvd Health Founder and CEO Keri Donaldson said in a statement.
Solvd's AvertD test is approved by the US Food and Drug Administration but faced backlash from a coalition of geneticists, addiction experts, psychiatrists, and public health researchers earlier this year. The group requested that the FDA revoke its approval and that the US Centers for Medicare and Medicaid Services deny coverage of the test.
In letters to the agency, this coalition argued that prevailing clinical evidence suggests that even whole-genome sequencing, let alone a test comprising only 15 variants, cannot predict opioid use disorder in a clinically meaningful way.
Solvd said it has been conducting prospective post-market studies to further evaluate AvertD’s performance in real-world settings.