New Test Identifies Who's at Risk for Opioid Use Disorder

The FDA recently approved the AvertD test, which can help healthcare providers determine if a person is at high risk of opioid use disorder before prescribing opioids.

On December 19, the FDA announced the approval of AvertD, a test developed by AutoGenomics, Inc. that uses DNA from a cheek swab to detect genetic variants linked to opioid use disorder (OUD). This testing could help doctors and patients make decisions on whether opioids are an appropriate choice for pain management.

The new test is intended for people 18 years or older with acute pain who are considering a 4 to 30-day prescription for opioids.

However, the FDA says the AvertD test is not for people who have taken opioids in the past or those with chronic pain.

Doctors can administer the test by swabbing the inside of a person's cheek. Once healthcare providers receive the results, they can work with the patient to make more informed decisions about whether to move forward with opioid treatment.

The FDA approval will require AutoGenomic, Inc. to provide training to healthcare providers and conduct a substantial post-market study examining the device's performance.

In addition, risks associated with the new test include the potential for false positive or false negative results. In the case of a false positive, where a person tests positive for OUD genetic risks but does not have them, the individual might not receive the medications needed to treat their acute pain.

On the other hand, a false negative, where a person tests negative for OUD genetic risks but actually possesses those gene variants, could result in physicians prescribing opioids to an at-risk individual.

Despite the uncertainty surrounding these benefits and risks, the FDA says the approval may make a positive impact on the ongoing opioid crisis, currently one of the most profound public health issues in the United States.

The agency previously approved other devices to combat the misuse of opioids, including an over-the-counter Narcan nasal spray. Narcan reverses the dangerous effects of an opioid overdose. In addition, healthcare providers can prescribe a new FDA-approved medication called buprenorphine (Brixadi) to treat OUD.

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