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FDA Approves Test to Identify Patients at Risk of Opioid Use Disorder

The FDA has approved the AvertD test, a DNA analysis tool designed to identify patients at risk of developing opioid use disorder before they are prescribed opioid analgesics. This approval comes as part of efforts to combat the ongoing opioid epidemic in the US.

The FDA has given the green light to the AvertD test, developed by AutoGenomics, which is the first of its kind in the US to use DNA analysis for identifying patients at risk of opioid use disorder (OUD). This test is intended for adult patients who are being considered for a short-term prescription of opioid analgesics for acute pain, specifically those who have not previously been prescribed oral opioids. The test involves a simple cheek swab and should be used as part of a comprehensive clinical evaluation and risk assessment, not solely based on genetic data.
The approval of AvertD is a significant step in addressing the opioid crisis, which remains a major public health challenge in the US. The epidemic has claimed tens of thousands of lives annually due to opioid overdoses, although there has been a recent slowdown in deaths. The test aims to prevent the onset of OUD, which can sometimes begin with a short-term prescription for acute pain.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, emphasized the importance of innovative measures in the fight against the opioid crisis. The FDA's decision to approve AvertD was informed by feedback from an advisory committee meeting, highlighting the need for tools that can assess the risk of developing OUD.
In addition to the AvertD test, the FDA has implemented other measures to tackle the opioid epidemic, including the approval of the first non-prescription naloxone nasal spray product for treating overdoses, as well as the first generic naloxone nasal spray and the first nalmefene nasal spray.
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Reference News

[1]
FDA OKs test to spot patients at risk of opioid use disorder
pharmaphorum.com · Apr 2, 2025

FDA approved AvertD, a DNA-based test by AutoGenomics, to assess opioid use disorder risk before prescribing opioids. Am...

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