NEW YORK — Solvd Health said on Monday that it has received CE marking for its genetic risk assessment test for opioid use disorder.
According to the Carlsbad, California-based company, the test analyzes a cheek swab sample for 15 genetic variants that have been implicated in the brain's reward pathway and can help guide the use of oral opioids for acute pain.
"Any time prescription opioids are used to manage pain, there is a risk of addiction," Solvd CEO Keri Donaldson said in a statement. "Knowing a patient's risk prior to opioid exposure gives clinicians and patients the data they need to make more informed decisions."
Solvd said the test is currently under review by the US Food and Drug Administration, which granted it a breakthrough device designation in 2018.