The U.S. Food and Drug Administration (FDA) recently approved AvertD, the first genetic test designed to identify individuals at elevated risk for developing opioid use disorder (OUD), a condition that has significantly impacted over 3 million Americans and their families. Developed by AutoGenomics, Inc., AvertD aims to be used before patients are exposed to opioid medications, such as in pre-surgical settings for adults aged 18 and older. This approval marks a step forward in efforts to combat the opioid crisis by potentially preventing new cases of OUD.
However, the introduction of AvertD has sparked a debate among health professionals and geneticists over its effectiveness and ethical implications. Critics argue that the test, which assesses risk based on 15 genetic markers, oversimplifies the complex interplay of genetic, social, economic, and psychological factors contributing to substance use disorders. They caution that reliance on genetic testing could divert attention from addressing the root causes of the opioid crisis, such as poverty, rural despair, and criminalization, which disproportionately affect marginalized communities.
Concerns have also been raised about the potential for the test to exacerbate existing racial and ethnic disparities in opioid prescription practices and access to treatment. The genetic markers used in AvertD have significant frequency differences across populations, leading to fears that the test could misclassify risk for individuals of non-white or mixed ancestries. This is particularly troubling given the test’s validation on a dataset predominantly comprising white patients.
Moreover, the cost of the test, currently priced at $199, may pose additional barriers to access, especially for those most in need of pain management solutions. Critics emphasize the importance of focusing on evidence-based harm reduction strategies, such as making Naloxone widely available and investing in treatment and service provision, rather than genetic testing.
As the medical community and regulatory bodies navigate these concerns, the debate underscores the need for a holistic approach to addressing the opioid crisis—one that considers the complex web of factors influencing substance use disorders and prioritizes equitable access to care and treatment for all affected individuals.
See “Why genetic testing is a tool — not a solution — to the opioid epidemic” by Sam Streuli, CJ Valasek, Cassidy Tomlinson, and Amy Non on The Hill website (January 28, 2024)
