Last Tuesday, the US Food and Drug Administration granted approval for a tool that makes use of genetic testing to assess the risk of certain individuals with regards to developing opioid use disorder (OUD).
Abuse of Opioids
In 2022, roughly 6 million individuals across the US, with ages 12 and above, had opioid use disorder. This was according to survey data of the US Department of Health and Human Services.
Deaths due to drug overdoses have also risen recently. Opioids have been observed to be involved in three-fourths of the cases. Last year, over 83,000 individuals died due to opioid-related overdoses, based on the US Centers for Disease Control and Prevention's data.
Opioid Medication Regulation
The test, dubbed AutoGenomic AvertD, was designed for adults who are considering taking oral opioid medications in the short term. This could be after going through surgical procedures.
Such medications can only be prescribed to those who have not used opioids in the past. Patients must also agree to the testing. It is not designed for those who are receiving treatment for long-term pain.
Dr. Jeff Shuren, the director of the Center for Devices and Radiological Health of the FDA, explains that the opioid crisis, which is one of the US's most profound public health concerns, is calling for novel ways to prevent, identify, and treat opioid use disorder.
Risk Testing Tool For Opioid Use Disorder
Dr. Shuren adds that the approval of the testing tool is a step forward in the agency's efforts to prevent more OUD cases from surfacing, support OUD treatment for affected individuals, and decrease opioid analgesic misuse.
However, its application in clinical settings is something that some experts are skeptical about. They caution that some limitations could lead to unintended consequences that are dangerous.
The test makes use of a cheek swab sample for the analysis of 15 genetic markers that play a role in the reward pathways of the brain and are linked to addiction.
Dr. Andrex Saxon, who is a psychiatry and behavioral sciences professor at the School of Medicine of the University of Washington, explains that genetics has a complex trade. This is not a Mendelian inheritance that is simple, where one gene is mutated and gives OUD. Rather, it involves multiple genes that lead to such effects.
There is also proof that such factors can surface to varying degrees in different demographic groups. This could make them difficult to point out in population samples. This is according to Dr. Jatherine Keyes, who serves as a professor of the School of Public Health at Columbia University Mailman and whose research mainly focuses on substance use and psychiatric epidemiology.
Dr. Keyes adds that the likelihood that a commercially developed OUD genetic test would have the validity necessary for driving clinical practice, based on the wider scientific literature, appears like a stretch. Dr. Keyes notes that asking people if they have a family history of addiction may be better at categorizing risk compared to the genetic test.
If the test were to be heavily relied on, false negative test results may offer patients and providers a higher sense of security regarding their OUD risk. Moreover, a false positive could limit a patient's access to medications that can help.
During the FDA advisory meeting in October 2022, the risk-benefit analysis of the test was mainly discussed. Ultimately, an independent panel advised against it.
Nevertheless, the FDA worked subsequently with AutoGenomics with test modifications. The new approval terms require that the company should offer training to healthcare practitioners for the test to be appropriately used and to perform large studies assessing performance after the market, with progress reports handed out regularly.
Dr. Shuren explains that test information could aid patients who are concerned about receiving opioid medications for acute pain in making more informed decisions. The information should also be utilized as part of a full clinical evaluation and assessment of risk. It should not be solely used for treatment decision-making.
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