FDA approves first genetic test to assess opioid addiction risk using DNA sample

• The U.S. Food and Drug Administration has approved the first test for assessing the risk of opioid use addiction in specific individuals.
• It is a prescription-use only genetic laboratory test intended for patients 18 years and older who have not previously used oral opioid painkillers.
• The test involves swabbing the patient’s cheek to collect a DNA sample, which is then analyzed to identify genetic variants linked to addiction.

The U.S. Food and Drug Administration (FDA) said on Tuesday it has approved the first test to assess if there is a risk of opioid use addiction in certain individuals.

The test, AvertD, is developed by privately held SOLVD Health. The FDA granted the approval to AutoGenomics, a unit that SOLVD acquired in 2019.

AvertD is intended to be used before the first use of oral opioid painkillers in those who are being considered for a 4 to 30 days prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure.

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It is a prescription-use only genetic laboratory test for patients 18 years and older for those who have not previously used oral opioid painkillers.

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.

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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.