US FDA approves first test to identify opioid use addiction risk

The United States Food and Drug Administration (FDA) said on Tuesday that it has approved the first test to determine whether some individuals are at risk of opioid addiction.

SOLVD Health, a privately held company, created the AvertD test. The FDA approved AutoGenomics, a unit that SOLVD acquired in 2019.

AvertD is meant to be used prior to the initial use of oral opioid painkillers in individuals who are being considered for a 4 to 30 day prescription for the management of acute pain, such as those undergoing a planned surgical procedure.

It is a prescription-only genetic laboratory test for people 18 and older who have never used oral opioid medications.

The test involves swabbing the cheek of a patient to collect a DNA sample that is then used to determine if there is a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder.

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.

AvertD is not intended to be used in patients being treated for chronic pain, the FDA said.

An advisory panel to the health regulator in October last year had convened to discuss an earlier version of the test.