The US Food and Drug Administration has approved the AvertD test by AutoGenomics, Inc., a genetic laboratory test for patients aged 18 and older to assess an individual’s risk for developing Opioid Use Disorder (OUD). AvertD is a prescription test for patients who may require an opioid prescription for the treatment of acute pain for a period of 4 to 30 days, such as during surgical procedures. The tests should be limited to patients who consent and have not previously consumed opioid analgesics. The FDA has provided guidelines for the use of AvertD test results, emphasizing that they should not be used in isolation but as part of the overall clinical assessment process. Patients being treated for chronic pain should be excluded from the test. The FDA also emphasizes the use of test results to address concerns of patients who may have reservations about using opioid analgesics.
The AvertD test must be conducted by a healthcare provider, who collects a DNA sample by swabbing the patient’s cheek. Subsequently, a combination of genetic variants associated with an increased risk of developing OUD is examined to determine the patient’s susceptibility to potential drug abuse.
In ongoing efforts to combat the drug overdose crisis and substance use disorder, this is the first FDA-approved test of its kind for OUD. In addition to this, the FDA also approved the first over-the-counter Naloxone nasal spray in March 2023 and subsequently the first generic over-the-counter Naloxone nasal spray in July 2023. The FDA also issued draft guidelines on „Clinical Considerations for Device Studies to Treat Opioid Use Disorder“ in July 2023.
AutoGenomics, Inc. is expected to provide training to healthcare providers to ensure the proper use of the test and conduct a large post-market study to assess the test’s performance in patients. According to the FDA, AutoGenomics, Inc. worked with the FDA to modify their original test based on FDA input and develop the currently approved version of the AvertD test.
The main risks associated with AvertD include false negative and false positive results. A false negative result could lead to a false sense of security in a patient at high risk of OUD, while a false positive result could lead to inadequate pain treatment due to opioid avoidance. To mitigate these risks, accurate and transparent product labeling and a healthcare provider training program are essential. „It is crucial for users of the test (healthcare providers and patients) to understand how to interpret the test result and use it as part of a comprehensive clinical assessment and risk evaluation, not in isolation,“ noted the FDA in their press release.