A coalition of scientists, doctors and public health experts is urging the Food and Drug Administration (FDA) to revoke its controversial approval of a DNA test claiming to predict genetic susceptibility to opioid addiction.
In December, the FDA greenlit AvertD, a prescription-only genetic lab test designed for patients aged 18 and above to be administered before doctors prescribe opioid pain medications.
However, the medical group has sent a letter to the FDA expressing concern, asserting that the approval was a misstep that jeopardizes patient safety. The 31 experts in genetics, addiction, and pharmacology argue that the scientific evidence supporting AvertD’s ability to predict genetic risk for opioid use disorder (OUD) is insufficient. They also highlight that the test relies on an approach abandoned by mainstream genetics.
“The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids,” the group writes.
Additionally, the coalition warns that patients who test positive could also face adverse consequences, as doctors may refrain from prescribing opioids even when they are medically warranted.
According to NBC News, the FDA’s approval of AvertD also went against the recommendation of its own independent advisory committee, which voted against approval in 2022. The committee raised concerns about the test’s accuracy in identifying people at risk for opioid addiction and its potential to contribute to overprescribing.
Despite the concerns raised, the FDA has declined to comment on the letter, according to The Washington Post. However, a spokesperson said that the agency found reasonable assurance of the test’s safety and effectiveness, citing the “urgent need for medical devices that can positively impact the overdose crisis.”