The U.S. Food and Drug Administration (FDA) granted approval of AvertD, a prescription-use-only genetic laboratory test, to AutoGenomics, a unit of SOLVD Health. It is the first test that uses DNA to identify whether adults have an elevated risk of developing opioid use disorder (OUD).
The AvertD test is a prescription-use only genetic laboratory test for patients 18 years and older and used to detect the presence or absence of 15 clinically relevant genetic polymorphisms in genomic DNA to help identify adults with an increased genetic risk of OUD. The test is intended to be used as part of a clinical evaluation prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, for example, patients scheduled to undergo a planned surgical procedure. The test is not intended to be used in patients being treated for chronic pain.
The approval is based on a prospective clinical study that assessed the performance of the AvertD test, with an additional retrospective element. The study enrolled 385 participants and evaluated participants who had experienced a 4-30 day exposure to prescription oral opioids 1-51 years prior to study enrollment (the retrospective element) to determine risk of developing OUD following such opioid exposure. The OUD status of each participant was determined by clinical evaluation during enrollment. The study results of the AvertD test, when tested in the clinical study population, demonstrated sensitivity of 82.76% (95% CI: 76.31, 88.05) and specificity of79.23% (95% CI: 73.06, 84.54) for detecting OUD. Of the 385 participants, 210 were OUD-negative and 175 were OUD-positive, as determined by the DSM-5 clinical evaluation. All 175 OUD-positive subjects were present in the high-risk group and 180 of the 210 OUD-negative subjects were present in the low-risk group. Additionally, test accuracy varied between ethnicities. The AvertD test accurately detected risk of opioid addiction 80.89% [95% CI: 73.86%, 86.72%] of the time in whites, but 91.67% [95% CI: 73.00%, 98.97%] of the time in Hispanics. The risks associated with the AvertD test are mainly false negative and false positive results.
As part of the FDA approval, AutoGenomic. must provide training to health care professionals to ensure appropriate use of the test. Given the ongoing opioid epidemic and concerning trends in opioid overdoses and deaths, the development of new risk tools for OUD could have a significant public health benefit, however, genetics are only one contributing factor in addiction. Genetic test information should be used as part of a complete clinical evaluation and risk assessment and should not be used alone to make treatment decision for patients.