FDA Approves First Test to ID Potential Risk of Opioid Addiction

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Dec. 21, 2023 -- The FDA has approved the first test that uses DNA to assess if people might have a higher risk of becoming addicted to opioids.

The prescription-only test, called AvertD, is designed to be used before opioids taken by mouth are given for acute pain – for example, before patients undergo a planned surgery. It’s meant for adults who have not used oral opioid painkillers in the past. And it’s not meant for patients experiencing chronic pain, the FDA said.

“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,” said Jeff Shuren, MD, of the FDA in a statement. “This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics.”

A DNA sample is collected by swabbing the cheek. The test then looks at a range of genetic variants that might be linked to a higher risk of developing opioid use disorder, Reuters reported.

“The addictive potential of the painkillers has fueled an opioid epidemic that has caused more than half a million overdose deaths in the United States over a period spanning more than two decades,” Reuters wrote.

The primary risks associated with AvertD are false negative and false positive results, Shuren said. “The risks of false negative and false positive results can be mitigated, in part, through accurate, transparent product labeling and a health care provider training program.”