The AvertD test uses a cheek swab to identify markers of potential opioid addiction.
Can a test determine if you’re at risk for opioid addiction? The U.S. Food and Drug Administration (FDA) thinks so.
That’s why the agency approved the use of the AvertD test on Tuesday, a first-of-its-kind test that assesses the risk someone carries of developing opioid use disorder.
The AvertD test is available by prescription only for people 18 and older. It is administered by a physician or other health care provider as a way to determine if a patient who may be prescribed opioids for acute pain management is at risk of becoming addicted to the pain pills. Acute pain management, such as a prescription given after a planned surgery, typically lasts four to 30 days. The test is not intended for patients being treated for chronic pain, the FDA said in its press release.
“Today, many doctors perform risk assessments prior to prescribing oral opioids—however, the tools currently available are largely non-standardized and have limited utility,” Dr. Keri Donaldson, CEO of SOLVD Health, the medical manufacturing company behind the AutoGenomics AvertD test, said in a press release in October 2021, marking the test’s launch. “We are proud to offer AvertD to help identify patients who may be at increased risk for [opioid use disorder]. Having personalized information about a patient’s genetic risk for [opioid use disorder] can help physicians make more informed decisions when considering oral prescription opioids for acute pain relief, particularly following elective surgical procedures.”
How It Works
Using DNA collected through a cheek swab, the test assesses whether a patient has a specific combination of genes that
researchers have determined are associated with an elevated risk of becoming addicted to opioids. The test analyzes 15 genetic markers that are part of the brain’s reward pathways. The results are then used as part of a complete clinical evaluation that enables physicians and patients to make the best decision about how to treat acute pain.
As part of the approval, physicians will be trained by AutoGenomics on how to administer and read the tests properly. Additionally, the company will conduct a postmarket study to assess the effectiveness of the test.
Test Poses Some Risk
The FDA noted the test comes with some risks, mainly that it could produce false negatives. An earlier version of the AvertD test, which went to the FDA in October 2022, did just that. The company was forced to make modifications to ensure false negatives and false positives wouldn’t occur. A false negative, after all, could lead “to a false sense of security for a patient who is at increased risk” of opioid addiction, the FDA wrote, while a false positive could lead to poor pain management. The risks of false positives and false negatives can be mitigated, the FDA noted, “through accurate, transparent product labeling and a health care provider training program.“It is critical that users of the test ... understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment,” the FDA wrote.
Opioid Epidemic Continues in the US
The AvertD test comes at a critical juncture in the American opioid crisis. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of people who have died from a drug overdose increased 10-fold from 1991 to 2021; nearly 75 percent of those deaths involved opioids.Opioid addiction often starts with prescription pain pills, which have often been readily available. In 2016, more than
11.5 million Americans said they misused prescription drugs. The CDC reports that over 150 million opioid prescriptions were written in 2019. The most common opioid overdose deaths, according to the CDC, were caused by methadone, oxycodone, and hydrocodone.
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