United States: A novel tool that uses genetic testing to determine whether certain people are at risk of developing opioid use disorder has been approved by the US Food and Drug Administration (FDA).
AvertD test is meant for those adults who are looking for a short-term course of oral opioid pain medications, such as after a planned surgery.
It is supposed to be prescribed only to people who have no prior use of opioids. Also, patients must give their consent to the test. It is said that it is not meant for those who are being treated for chronic pain, CNN Health reported.
Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder.”
He further mentioned, “This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics.”
Know more about the test
The AutoGenomics AvertD test uses a sample from a cheek swab and analyzes 15 genetic markers that are involved in the brain’s reward pathways and associated with addiction.
Dr Andrew Saxon, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine, said genetics are a “complex trade” and further added, “It’s not a simple Mendelian inheritance where one gene has a mutation and that gives you opioid use disorder. It’s a multitude of different genes, all contributing to this effect.”
Dr Katherine Keyes, a professor at the Columbia University Mailman School of Public Health whose research focuses on psychiatric and substance use epidemiology, said that it is a proven fact that these factors can show up in varying degrees across demographic groups, which can make them hard to identify in population samples, CNN Health reported.
What are the prevailing concerns?
Some experts have shown concern about its use in clinical practice and warned that some of its limitations could have dangerous unseen consequences.
If the genetic test is depended upon heavily, then there is a chance of getting a false sense of security about their risk of developing opioid use disorder by the patients and the test providers in case of receiving a false negative result on the test. This false positive could limit a patient’s access to useful medications, as per CNN Health report.
At an FDA advisory committee meeting held in October 2022, this risk-benefit analysis was at the heart of its discussion. And an independent panel eventually recommended against it in an 11-2 vote.
Subsequent work of the FDA with AutoGenomics further modified the test. In this, the terms of the new approval require the company to provide required training to healthcare providers in the appropriate use of the test and to conduct a large study assessing post-market performance with regular progress reports.
Current Scenario
In 2022, around 6 million people in the US aged 12 and older had an opioid use disorder, as per the recent survey data from the US Department of Health and Human Services.
In recent years, drug overdose deaths have also increased, with opioids involved in about three-quarters of the time.
As per the data from the US Centers for Disease Control and Prevention, more than 83,000 people died from an overdose involving an opioid last year.
Keyes said, “I do still think that prescribed opioids remain a prominent risk factor for the development of opioid use disorder,” and added further, “I would just encourage clinicians to look at the literature and make sure that they’re comfortable with the level of safety of the product,” CNN Health reported.