FDA approves DNA test to assess risk for developing opioid use disorder
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Key takeaways:
- AvertD is the first test approved by the FDA to evaluate an elevated risk for developing opioid use disorder.
- The test is meant to be used before a patient’s first exposure to oral opioid medication.
The FDA has approved AvertD, the first DNA test to identify an elevated risk for developing opioid use disorder, according to a press release.
The AvertD (AutoGenomics, Inc.) test is for patients 18 years or older who are being considered for a 4-to-30-day prescription for the treatment of acute pain, the FDA said. The prescription-only genetic laboratory test is meant to be used before the first exposure to oral opioid medication among patients who have consented and have no prior use of oral opioid analgesics.
According to the release, after a health care provider collects DNA with an oral swab of the cheek, the test will determine if a patient has a combination of genetic variants that may be associated with an elevated risk for developing opioid use disorder. However, the results from the test should be used in conjunction with a complete clinical evaluation and risk assessment and should not be the only factor for treatment decisions. For patients with acute pain who are concerned about using opioids to manage pain, the AvertD test may better inform their treatment decision, the FDA said. The test is not intended for use among patients seeking treatment for chronic pain.
According to the release, the primary risks associated with the test are both false negative results and false positive results. While these risks are usually associated with an in vitro diagnostic test, they can be mitigated “through accurate, transparent product labeling and a health care provider training program,” the FDA said.
The approval of AvertD requires AutoGenomics, Inc. to provide training for health care providers to ensure that the test is used appropriately, as well as conduct a large post-market study to assess its performance among patients.