The U.S. Food and Drug Administration (FDA) has approved the first test that uses DNA to assess whether someone is at higher risk of opioid use disorder. The test, AvertD, is intended to be used on patients who are being considered for a four to 30 day opioid pain medication prescription. “Such as in patients scheduled to undergo a planned surgical procedure,” Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.
AvertD is not meant for patients undergoing chronic pain treatment but is exclusively designed for acute pain scenarios.
This prescription-only test is available for patients aged 18 and above. During the test, healthcare providers collect a DNA sample by swabbing the patient’s cheek, and the sample is then examined for genetic variants associated with an elevated risk of developing opioid use disorder.
“This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions,” Shuren said.
The FDA has faced criticism for helping fuel the opioid crisis in America by approving the powerful painkiller OxyContin, promoted by Purdue Pharma.
“The root cause of this epidemic is the FDA’s illegal approval of opioids for the treatment of chronic pain,” Ed Thompson, a drug manufacturer who spent decades managing and producing opioids for Big Pharma, told CBS News.
According to the Centers for Disease Control and Prevention, a record number of Americans–approximately 112,000–have died from drug overdoses and fentanyl poisoning over the past year.
“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,” Shuren said.
SOLVD Health developed AvertD, but the FDA granted the approval to AutoGenomics, a unit that SOLVD acquired in 2019.