Researchers say a test meant to measure risk for opioid use disorder may cause harm. Their arguments are part of a larger debate about using genetic information to guide clinical care.
The focus of the request is AdvertD , which the US Food and Drug Administration approved in December as the first test to use DNA to evaluate if people have an elevated risk for opioid use disorder . A sample obtained through a cheek swab is meant to help guide decisions about opioid prescriptions for patients not previously treated with these drugs, such as someone undergoing a planned surgery,
"The harmful consequences of an invalid genetic test for OUD are clear. Patients who test negative, and their clinicians, may have a false sense of security about use of opioids," the letter states. Hatoum said many patients may not fully understand the limit of genetic testing in predicting conditions like risk for OUD, where many factors are at play. The availability of a test may lend the impression that a single DNA trait makes the difference, as happens with conditions likeThe FDA declined to comment on the letter and said its approval of the test was "another step forward" in efforts to prevent new cases of OUD.
The company failed to impress the FDA's Clinical Chemistry and Clinical Toxicology Devices Panel, which in October 2022, said the probable risks of the test likely outweighed its benefits.to consider the challenges and possibilities in developing tools to predict the risk of developing OUD. At that meeting, Keri Donaldson, MD, MSCE, the chief executive officer of SOLVD, said the company planned to conduct a controlled rollout of AdvertD on FDA approval.
The FDA approved the test in December 2023, saying it had worked with the company on modifications to its test. It also said that the advisory committee's feedback helped in the evaluation and ultimate approval of AdvertD.
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