The FDA has approved the AvertD test, a groundbreaking tool designed to identify the risk of opioid addiction. This test, available by prescription for individuals aged 18 and above, involves a cheek swab to analyze 15 genetic markers associated with the brain’s reward pathways. Administered by healthcare providers, the AvertD test aims to assess a patient’s likelihood of developing opioid use disorder, particularly in the context of acute pain management following procedures like surgery. It is not intended for those undergoing chronic pain treatment.
Dr. Keri Donaldson, CEO of SOLVD Health, the company behind the test, emphasized its potential to enhance risk assessments before prescribing oral opioids. The personalized genetic information obtained from the test can assist physicians in making more informed decisions about opioid prescriptions.
However, the FDA acknowledged potential risks, such as false negatives, which could provide a false sense of security for patients at increased risk of opioid addiction, and false positives, leading to suboptimal pain management. To address these concerns, the FDA emphasized the importance of accurate product labeling, a healthcare provider training program, and the integration of test results into a comprehensive clinical evaluation and risk assessment.
The approval of the AvertD test coincides with the ongoing opioid crisis in the United States. With drug overdose deaths, especially opioid-related, on the rise, the test is seen as a crucial tool to curb addiction risks associated with opioid prescriptions. Physicians will undergo training on proper test administration and interpretation, and a postmarket study will be conducted to assess the test’s effectiveness.