The Food and Drug Administration on Tuesday approved the first-ever genetic test to assess if a patient is at risk of opioid use addiction.
AvertD is intended to be used prior to a patient's first exposure to opioid painkillers for treatment of acute pain, such as after a scheduled surgical procedure.
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"The opioid crisis, one of the most profound public health issues facing the United States, calls for innovated measures to prevent, diagnose, and treat opioid use disorder, including to assess the risk of developing the disorder," Jeff Shuren, FDA's Director for the Center for Devices and Radiological Health, said in a press statement.
Avert D is a prescription-use genetic laboratory test that is administered by swabbing the cheek of a patient over the age of 18. The test collects a DNA sample that will be examined to determine if the patient has a combination of genetic variants that are associated with an elevated risk of developing opioid use disorder.
The beginning of the opioid epidemic in the United States is often marked as beginning in the mid-1990s with relaxed regulations on OxyContin for pain management.
Shuren says that the availability of genetic testing for a predisposition to opioid abuse "may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions."
An earlier version of the test was examined by an FDA advisory committee in Oct. 2022. Since that time, the FDA has been working with the developer, AutoGenomics, to get the product ready for full approval.
The product, however, is not without its risks and should be used by clinicians as one of many tools for a comprehensive assessment of a patient's risk of developing opioid use disorder. False positives and negatives do occur.
"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," said Shuren.
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AvertD is one of the multiple steps the FDA has taken in recent years to curb the opioid crisis, such as approving the first non-prescription naloxone nasal spray.
The opioid epidemic has claimed approximately half a million lives in overdose deaths in the United States over the past 20 years. Nearly 110,000 Americans died from drug overdoses in 2022, over three-quarters of which are attributable to opioids.