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AutoGenomics Test to Evaluate Opioid Use Disorder Risk Gets the Nod from FDA

NextEdge Admin

18 Nov 2023

1 min 54 sec

The US Food and Drug Administration (FDA) has granted approval for AutoGenomics’ AvertD test, designed to identify individuals at an elevated risk of developing opioid use disorder (OUD). Utilizing DNA extracted from a cheek swab, the test assesses genetic variants associated with an increased likelihood of OUD development. Specifically, AvertD is recommended for use prior to the initial exposure to oral opioid pain medications, targeting patients eligible for a four- to 30-day prescription for acute pain treatment, excluding those with chronic pain.

The FDA emphasizes the test’s supplementary role, emphasizing that clinical evaluation and risk assessment should accompany the genetic information provided by AvertD. Notably, this marks the first FDA-approved test employing DNA analysis to gauge an individual’s potential susceptibility to OUD.

AutoGenomics, based in Carlsbad, California, is mandated to furnish training to healthcare practitioners to ensure proper test utilization. Additionally, the company is required to conduct an extensive post-market study to evaluate the test’s performance in real-world patient scenarios. The FDA justifies its decision by considering available evidence, the urgency posed by the overdose crisis, patient perspectives, public health demands, and the potential to address uncertainties through post-market data collection.