The FDA approved the first test that uses DNA to identify whether adults have an elevated risk of developing opioid use disorder (OUD), the agency said Tuesday.
The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. It is not intended for patients being treated for chronic pain, the agency said.
“AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA granted approval of AvertD, a prescription-use-only genetic laboratory test, to AutoGenomics, a unit of SOLVD Health. In October 2022, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.
The earlier AvertD version detected the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. At the advisory committee meeting, SOLVD presented results of an observational study that demonstrated a sensitivity of 82.76% and a specificity of 79.23% for detecting OUD.
Following the advisory committee meeting, the FDA worked with AutoGenomics as it revised its test. The company subsequently submitted a premarket approval application for the modified test.
The test involves swabbing a patient’s cheek to collect a DNA sample. As part of the approval order, AutoGenomics must provide training to healthcare providers to help ensure the test is being used appropriately. The company also must conduct a large post-marketing study to assess AvertD’s performance in patients and regularly report the study’s progress to the FDA.
The primary risks associated with AvertD are false-negative and false-positive results, the FDA noted. A false-negative result could lead to a false sense of security for a patient who has an increased risk of OUD; a false-positive result could lead to inadequate pain management.
“The risks of false-negative and false-positive results can be mitigated, in part, through accurate, transparent product labeling and a healthcare provider training program,” the FDA said. “It is critical that users of the test (healthcare providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.”
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