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The Food and Drug Administration (FDA) has recently approved the groundbreaking AutoGenomics AvertD test, the first DNA test designed to evaluate an individual’s risk for developing opioid use disorder.

Specifically tailored for adults contemplating short-term opioid pain medication for acute pain, such as post-surgery treatment, the test aims to aid in more informed decision-making.

Administered by a healthcare provider via cheek swab, the AvertD test analyzes the patient’s DNA to identify genetic variants associated with a heightened risk of opioid use disorder. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, highlighted the significance of this innovation, stating, “The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder.” He also noted that the test’s approval is a step forward in the FDA’s ongoing efforts to tackle the opioid crisis by preventing new cases, supporting treatment, and reducing misuse.

This approval comes after modifications to the original test, which an FDA advisory panel rejected due to concerns over safety and efficacy. Following the agency’s guidance, the manufacturer revised the test and reapplied under a stricter approval pathway. As a condition of approval, the manufacturer is required to provide comprehensive training to healthcare providers, conduct extensive post-market studies, and submit regular progress reports to the FDA.