February 17, 2024

FDA Approves First Test to Help Identify Risks of Developing Opioid Use Disorder

As reported on the Healthesystems MedMonitor website in late 2023, the FDA approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD).

As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain.

The test is not intended to be used in patients being treated for chronic pain.

The AvertD test is a prescription-use only genetic laboratory test to be used only with patients aged 18 and older who consent to the test and have no prior use of oral opioid analgesics. 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 OUD.

Information gathered from this test should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions.

As part of the approval order, AutoGenomic, Inc. must provide training to health care providers to help ensure appropriate use of the test and conduct a large post-market study assessing device performance in patients, regularly reporting progress made toward completion of that study to the FDA.

The primary risks associated with AvertD, as with any in vitro diagnostic test, are false negative and false positive results. A false negative result could lead to a false sense of security for a patient who is at increased risk of OUD, and/or a health care provider considering prescribing an opioid analgesic which could result in a provider prescribing an opioid analgesic to a patient to whom they would otherwise not do so.

The risks of a false positive result (i.e., incorrectly identifying an individual as having a higher risk of OUD) include inadequate pain management due to avoidance of opioids, which may prevent patients from receiving optimal medical care to treat their acute pain.

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