The first-ever DNA test to help determine if someone has a greater risk of developing opioid use disorder was approved by the Food and Drug Administration (FDA) this week.
The FDA approved the AutoGenomics AvertD test for use among adults who are considering treating acute pain with short-term prescription of opioid pain medicine, such as after a planned surgery.
The test is not intended to be used by patients being treated for chronic pain. The information from the test may help patients make better informed decisions, the FDA said. The agency stressed the information should be used as part of a complete clinical evaluation and risk assessment and shouldn’t be used alone to make treatment decisions.
The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder.
“The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“This approval represents another step forward in the FDA’s efforts to prevent new cases of [opioid use disorder], support the treatment of those with the disorder and decrease the misuse of opioid analgesics.”
The FDA’s approval comes after an agency advisory panel last year overwhelmingly rejected an earlier version of the test based on safety and efficacy data.
Shuren said the agency worked with the manufacturer as it modified its test and subsequently submitted a different application under a stricter approval pathway for the new test.
As part of the approval, the manufacturer must provide training to health care providers to help ensure appropriate use of the test, conduct a large post-market study assessing device performance in patients and submit regular progress reports to the FDA.
The primary risks associated with AvertD — as with any diagnostic test — are false results. False negatives could lead to a “false sense of security” for someone who may have an increased risk of opioid use disorder, while false positives could lead to inadequate pain management treatment, the FDA said.
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