Genetic Test for Opioid Addiction Risk Should Be Withdrawn, Experts Tell FDA
A group of 31 physicians and researchers called on the FDA to reverse its decision about AvertD, a test that uses DNA to identify whether adults may have an elevated risk of developing opioid use disorder (OUD). In a letter to FDA Commissioner Robert Califf, MD, experts in genetics, addiction, psychiatry, public health, and device […]
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say
An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of […]