A group of health experts warned against a genetic test recently approved by the U.S. Food and Drug Administration (FDA) that claims to be able to identify a person’s risk of opioid addiction, noting that the test may produce false results.
Developed by California-based SOLVD Health, the test is conducted by evaluating DNA samples of patients against 15 genetic markers identified with opioid addiction. The results are run through an algorithm which outputs a score in the range of zero to one with values equal to or higher than 0.33 considered to indicate a high genetic risk for opioid use disorder.
The algorithm used for the analysis was trained on a genetic database of over 7,000 people, some of whom had OUD.
“AvertD detects 15 common single nucleotide polymorphisms (SNPs). This test is based on an approach that has been abandoned by mainstream genetics,” states the letter, adding that there was inadequate evidence for predicting the disorder.
“The largest well-powered and state-of-the-art genome-wide studies of OUD to date demonstrate that even a full genome’s worth of markers (roughly 6,000,000) is not sufficient to predict OUD in a clinically useful way.”
An evaluation of the AvertD algorithm by geneticists found that it only gave the “appearance of predicting genetic risk” and was not a “true measure of genetic risk,” the letter says.
After accounting for ancestry, results from the AvertD test did not fare “any better than chance” when it came to predicting opioid addiction risk.
The letter warns that genetic testing for opioid use disorder can result in several harmful consequences if test results are incorrect.
Patients who get false negative results may end up having a false sense of security about using opioids, the letter said.
Meanwhile, false positive results may force clinicians to avoid prescribing opioids to patients in such instances even when the drugs may be beneficial.
The authors noted that the issue of false results may get “magnified” in specific communities with a low population.
“Moreover, a substantial number of people may be wrongly labeled as prone to OUD, a highly stigmatized medical condition. These patients may face discrimination and other negative health and social consequences.”
The letter noted that the FDA’s own scientific advisers had voted 11–2 against approving AvertD precisely due to concerns about false positive results. It called the FDA decision to approve AvertD despite opposition from the advisory committee, geneticists, and other experts “surprising.”
AvertD may end up making the opioid crisis “worse” as false negative test results may lead to overprescription of opioids in such patients.
This would stand in contrast to FDA claims that AvertD was a “step toward addressing the opioid crisis,” the letter stated.
The authors asked the FDA to go through the peer-reviewed publications cited as part of the letter. “We are hopeful that after careful review you will agree with the expert consensus that that the decision to approve AvertD was a mistake, and that the approval should be rescinded,” they wrote.
Signatories of the letter include experts associated with John Hopkins University, Duke University Medical Center, University of Washington, Stanford University School of Medicine, and the Yale University Schools of Medicine and of Public Health.
FDA Committee on AvertD
While announcing the approval for AvertD in December, the FDA admitted that false negative and positive results were one of the “primary risks” associated with the test.“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks,” the agency said.
However, “given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD’s safety and effectiveness.”
The discussion resulted in an 11–2 vote against approving the test. The 11 panel members who voted against approving AvertD “generally felt that there was continuing uncertainty regarding the validity of the test given that it is unclear whether the 15 SNPs used in the device are predictive of OUD,” according to a meeting summary.
Panel members pointed out that AvertD’s clinical study on their tests was “not powered to assess important subgroups in the general population.” The people enrolled in the study failed to capture “the full spectrum of subjects within the intended use population.”
Some members were also concerned that “no information was provided regarding how the results of the test impact potential for over-use of opioids in low-risk population and potential for under-use of opioids in the high-risk population.”
These 11 members eventually decided that the risks associated with the AvertD test “outweighed the benefits.”
The FDA approval of AvertD comes as the United States is facing an accelerating opioid crisis.
The Epoch Times has reached out to the FDA for comment.
