In a groundbreaking move, the U.S. Food and Drug Administration (FDA) announced on Tuesday its approval of the first-ever test designed to assess the risk of opioid use addiction in specific individuals. The innovative test, named AvertD, was developed by SOLVD Health, a privately held company. The FDA granted approval to AutoGenomics, a unit acquired by SOLVD Health in 2019, signifying a significant step in addressing the ongoing opioid crisis.
AvertD is a prescription-use-only genetic laboratory test intended for individuals aged 18 and older who have not previously used oral opioid painkillers. It is specifically designed to be administered before the initial use of oral opioid painkillers in those considering a 4 to 30-day prescription for the treatment of acute pain, such as patients scheduled for planned surgical procedures.
The testing process involves a simple cheek swab to collect a DNA sample from the patient. This sample is then analyzed to determine if there is a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder. By identifying individuals at a higher risk, healthcare providers can make more informed decisions about prescribing opioid medications, potentially preventing the onset of addiction.
The opioid epidemic in the United States has been a major public health concern, contributing to over half a million overdose deaths over a span of more than two decades. The addictive nature of opioid painkillers has played a central role in fueling this crisis, making the approval of AvertD a significant milestone in efforts to combat opioid addiction.
It’s important to note that AvertD is not intended for use in patients being treated for chronic pain, emphasizing its focus on assessing the risk associated with acute pain management. The FDA highlighted that an advisory panel convened in October of the previous year to discuss an earlier version of the test, underscoring the thorough evaluation process leading to its eventual approval.
This development marks a pivotal moment in the fight against opioid misuse and addiction, as precision medicine takes a step forward in identifying those at higher risk and potentially curbing the devastating impact of opioid misuse and dependency.