Scientists urge FDA to rescind approval of test for opioid addiction risk
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A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
The Washington Post last month highlighted concerns about the test’s reliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
“The harmful consequences of an invalid genetic test for [opioid use disorder] are clear,” the experts wrote.
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