NEW YORK – The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).
The AvertD test uses DNA collected from a cheek swab to determine if a patient has a combination of genetic variants that may be associated with higher risk of developing OUD, the FDA said in a statement. It is intended to be used before first exposure to oral opioid pain medications in patients being considered for a four- to 30-day prescription for the treatment of acute pain, the agency noted. The assay is not intended for use in patients being treated for chronic pain.
Information from the prescription-use-only test should be used in combination with a complete clinical evaluation and risk assessment, the FDA added. AvertD is the first test that uses DNA to assess an individual's potential elevated risk of OUD, it said.
As part of its approval, Carlsbad, California-based AutoGenomics must provide training to healthcare providers to ensure appropriate use of the test and perform a large post-market study determining the test's performance in patients, the FDA said.
"Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness, taking into consideration available alternatives, patients' perspectives, the public health need, and the ability to address uncertainty through the collection of post-market data," the agency said.
In 2018, the FDA launched an innovation challenge to help companies achieve accelerated approvals to market their technologies to help combat the opioid crisis.