The Food and Drug Administration of the United States gave its approval on Tuesday to a novel tool that makes use of genetic testing to assist in determining whether or not particular individuals are at risk of developing opioid use disorder.
Adults who are contemplating a short-term course of oral opioid pain drugs, such as after a planned surgical operation, are the target audience for the AutoGenomics AvertD test. Patients are required to provide their assent to the test, and it is only possible to prescribe it to individuals who have never used opioids before. However, it is not intended for people who are currently receiving treatment for persistent pain. “The opioid crisis, which is one of the most significant 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,”
Dr. Jeff Shuren, director of the Center for Devices and Radiological Health at the Food and Drug Administration, said in a statement. An additional step forward in the efforts of the Food and Drug Administration (FDA) to prevent new cases of opioid use disorder (OUD), promote the treatment of those who have the illness, and reduce the misuse of opioid analgesics is represented by this approval.
A number of specialists, on the other hand, are sceptical regarding its application in clinical settings, and they warn that some inadequacies of the system could result in potentially harmful unintended outcomes.
There are fifteen genetic markers that are implicated in the reward circuits of the brain and are connected with addiction. The AvertD test analyzes a sample taken from a cheek swab to determine these markers.
However, genetics are a “complex trade,” according to Dr. Andrew Saxon, who is a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. “Opioid use disorder is not a straightforward Mendelian inheritance, in which a single gene is mutated and the result is the development of the disorder. This effect is caused by a wide variety of genes, each of which contributes in its own unique way.
According to Dr. Katherine Keyes, a professor at the Columbia University Mailman School of Public Health whose research focuses on psychiatric and substance use epidemiology, there is evidence that these factors can show up in varying degrees across demographic groups, which can make it difficult to identify them in population samples. This is something that can make it difficult to identify them in population samples.
