On December 21, 2023, the FDA granted approval for the inaugural DNA-based test aimed at gauging an individual’s susceptibility to opioid addiction.
Known as AvertD, this prescription-only test is specifically designed for pre-assessment before administering orally consumed opioids for acute pain, especially prior to scheduled surgeries. Targeting adults without a history of oral opioid painkiller use, the test is not intended for those grappling with chronic pain, according to the FDA.
Jeff Shuren, MD, of the FDA emphasized the urgency of addressing the opioid crisis, stating, “This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder, and decrease the misuse of opioid analgesics.”
A swab of the cheek is used to collect a DNA sample, with the test examining various genetic variants associated with an elevated risk of developing opioid use disorder, as reported by Reuters.
Opioid painkillers’ addictive potential has fueled a crisis leading to over half a million overdose deaths in the United States over more than two decades, according to Reuters.
Primary concerns linked to AvertD involve potential false negatives and false positives, according to Shuren, who suggests that accurate labeling and healthcare provider training can help mitigate these risks.
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