Solvd Health Pharmacogenomics Test Gets NYS Department of Health Approval

Original from: genomeweb

Solvd Health said Wednesday that its pharmacogenomics (PGx) test PreScript has received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP).

The approval enables San Diego-based Solvd Health to offer its PGx testing services to healthcare providers and patients in New York state.

PreScript uses a cheek swab sample to analyze 14 genetic variants that impact how a person's body metabolizes medication, according to the company's website. Providers receive a detailed report that indicates how an individual will respond to the medications they are currently prescribed, as well as any medications being considered for future use, the company said.

"Approval from the New York State Department of Health underscores our commitment to delivering actionable insights that transform healthcare," Solvd Health Founder and President Keri Donaldson said in a statement. "Pharmacogenomics is a cornerstone of personalized medicine, and this clearance allows us to expand access to tools that help clinicians make safer, more effective prescribing decisions."

The approval comes about a year after Solvd received NYS DOH CLEP approval for its San Diego-based laboratory, allowing it to offer its AvertD PGx assay to help guide the prescription of opioid medications. AvertD also previously received US Food and Drug Administration approval, a decision that has faced backlash from industry stakeholders, who argued that clinical evidence for the assay was lacking.

Source: Solvd Health Pharmacogenomics Test Gets NYS Department of Health Approval