FDA Greenlights Pioneering Test for Detecting Increased Risk of Opioid Use Disorder

The U.S. Food and Drug Administration has granted approval for the AutoGenomics, Inc. AvertD test, marking a significant milestone as the first test utilizing DNA to assess the elevated risk of developing opioid use disorder (OUD). Positioned for use in clinical evaluations, the prescription-use-only genetic laboratory test is designed for patients aged 18 and above who are being considered for a 4-30 day prescription of oral opioid pain medications to address acute pain, such as those anticipating a planned surgical procedure.

Administered by healthcare providers, the AvertD test involves swabbing the patient's cheek to collect a DNA sample. This genetic information is then analyzed to identify any combination of genetic variants associated with a heightened risk of OUD. Notably, the test is exclusively intended for patients who consent to the assessment and have no prior history of oral opioid analgesic use. It is emphasized that the AvertD test should be a component of a comprehensive clinical evaluation and risk assessment, not a standalone factor for treatment decisions. Specifically excluded from its intended use are patients undergoing chronic pain treatment. The approval of AvertD represents a valuable tool to assist patients, particularly those concerned about opioid treatment for acute pain, in making more informed decisions.

SOURCE: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-approves-first-test-help-identify-elevated-risk-developing-opioid-use-disorder 

CREDITS: U.S. FOOD AND DRUG ADMINISTRATION