ASA Monitor March 2024, Vol. 88, 14.
Test to assess risk for opioid use disorder
The FDA has granted approval to the AutoGenomics, Inc. AvertD test, the first genetic laboratory test designed to assess the elevated risk of developing opioid use disorder in certain individuals. The test is a prescription-use-only genetic test for patients aged 18 and older, intended for use before the first exposure to oral opioid pain medications in patients being considered for a four-30-day prescription for acute pain, such as those undergoing planned surgical procedures. Administered by health care providers, the test involves swabbing the patient’s cheek to collect a DNA sample, which is then used to determine if the patient has a combination of genetic variants associated with an elevated risk of developing opioid use disorder. It is not intended for patients being treated for chronic pain and should be part of a complete clinical evaluation and risk assessment. AutoGenomics, Inc. is required to provide training to health care providers for the appropriate use of the test and to conduct a post-market study to assess device performance, regularly reporting progress to the FDA.
Source: asamonitor.pub/3RMfS9f
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