FDA approves genetic test to assess patient's risk of developing an opioid addiction

AUSTIN (KXAN) – The U.S. Food and Drug Administration approved Tuesday the first test to detect if someone might be at an increased risk of developing opioid use disorder by looking at their DNA before they are exposed to opioids for the first time. 

AutoGenomics, Inc. developed the AvertD test to be used in clinical evaluations before a patient is prescribed opioids for acute pain management, such as prior to a planned surgical procedure.

It works by a healthcare provider swabbing a patient's cheek and collecting a DNA sample that is used to assess whether a patient has a combination of genetic variants that could be associated with an increased risk for developing opioid use disorder. The AvertD test is intended only for adult patients who have consented to the procedure. 

“[This is] very positive. I think it's always helpful to have another tool in our toolbox to help address the opioid crisis, which is terrible,” said Dr. Ziyad Nuwayhid, the Chief Medical Officer for Integral Care – the Local Mental Health Authority for Austin Travis County.

“I conduct some of the death reviews for when our patients are involved in opioids, and fentanyl in particular are taking a terrible toll,” he continued.

Prescription opioids are sometimes prescribed to treat moderate to severe pain, but they come with risks. The Centers for Disease Control and Prevention estimated that one in four patients receiving long-term opioid therapy struggle with addiction. In 2016, over 11.5 million Americans reported misusing the medication within the previous 12 months. 

Further, drug overdose deaths remain high. In 2021, there were 107,00 drug overdose deaths nationwide, and over a quarter of those deaths involved an opioid, according to the CDC. 

“For the folks who are most likely to get their first opioids from a doctor, this is the kind of [test] where you can say, ‘Hey, you know, is this the right decision for this patient?’ And I can place a good amount of reliability [on the results],” Nuwayhid said.

“Projecting out--it could save thousands upon thousands of lives,” he continued. 

Nuwayhid said this test has the potential to have a large impact; however, when tests and medications are newly approved, they tend to be expensive.

“There will probably be some programs designed to increase access to it. And if it proves wildly successful, people will be more encouraged to pick up the cost,” he continued.