The U.S. Food and Drug Administration on Tuesday approved a new tool that uses genetic testing to help assess whether certain people are at risk for developing opioid use disorder. The AutoGenomics AvertD test is indicated for adults who are considering oral opioid pain medication for a short period of time, such as after a planned surgical procedure. It can only be prescribed to people who have not used opioids before, and the patient must consent to testing. It is not suitable for those receiving treatment for chronic pain. The opioid crisis is one of the most profound public health issues facing the United States and calls for innovative approaches to prevent, diagnose and treat opioid use disorder, including assessing risk, Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement expressed in. This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of patients with the disease, and reduce the misuse of opioid analgesics. However, some experts are skeptical of its use in clinical practice and warn that some of its limitations could have dangerous unintended consequences. The AvertD test uses a cheek swab sample to analyze 15 genetic markers involved in the brain’s reward pathways and associated with addiction. But genetics is a complex business, said Dr. Lee, a professor of psychiatry and behavioral sciences at the Washington University School of Medicine. This is not a simple Mendelian inheritance, where a mutation in one gene causes opioid use disorder. Several different genes contribute to this effect. There is evidence that these factors can occur to varying degrees in different population groups, making them difficult to identify in population samples, said Dr. Katherine Case, a professor at the university. Research at Columbia University Mailman School of Public Health focuses on psychiatry and substance abuse epidemiology. Therefore, based on the broader scientific literature, commercially developed genetic tests for OUD may have the validity needed to truly advance clinical practice. , seems far-fetched, she said. If you just ask people, do you have a family history of addiction? I’m assuming this would be a better risk classifier than genetic testing. Even asking a patient about their drug use history, particularly tobacco use, can be just as insightful, Saxon said. If too much reliance is placed on genetic testing, false negative results from the tests may give patients and their providers an exaggerated sense of security about their risk for opioid use disorder, while false positives may limit patients’ access to helpful medications. At the heart of this risk-benefit analysis was a discussion of the test at an FDA advisory committee meeting in October 2022, with the independent panel ultimately recommending against the test in an 11-2 vote. Fone subsequently worked with AutoGenomics to modify the test. Terms of the new approval require the company to provide training to health care providers on the proper use of the test and conduct a large study to evaluate post-market performance and report progress regularly. Information from the test may help patients who are worried about being affected. Treating acute pain with opioids allows for more informed decisions, Shuren said. This information should be used as part of a complete clinical evaluation and risk assessment; According to recent survey data from the U.S. Department of Health and Human Services, approximately 6 million people ages 12 and older will have an opioid use disorder in the United States by 2022. Drug overdose deaths have surged in recent years, with about three-quarters involving opioids. More than 83,000 people died from opioid overdoses last year, according to the Centers for Disease Control and Prevention. ‘I still think prescription opioids remain a prominent risk factor for opioid use disorder,’ Case said. I just encourage clinicians to look at the literature and make sure they’re comfortable with the safety level of the product.
The U.S. Food and Drug Administration on Tuesday approved a new tool that uses genetic testing to help assess whether certain people are at risk for developing opioid use disorder.
The AutoGenomics AvertD test is indicated for adults who are considering oral opioid pain medication for a short period of time, such as after a planned surgical procedure. It can only be prescribed to people who have not used opioids before, and the patient must consent to testing. It is not suitable for those undergoing treatment for chronic pain.
“The opioid crisis is one of the most profound public health issues facing the United States and requires innovative approaches to prevent, diagnose and treat opioid use disorder, including assessing the risk of developing the disease,” said FDA Director Dr. Jeff Shuren. the Center for Devices and Radiological Health said in a statement. This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support treatment for people with the disease, and reduce the misuse of opioid analgesics.
However, some experts are skeptical of its use in clinical practice and warn that some of its limitations could have dangerous unintended consequences.
The AvertD test uses cheek swab samples to analyze 15 genetic markers involved in the brain’s reward pathways and associated with addiction.
But genetics is a complex industry, said Dr. Andrew Saxon, a professor of psychiatry and behavioral sciences at Washington University School of Medicine. This is not a simple Mendelian inheritance, where a mutation in one gene causes opioid use disorder. It has a number of different genes, all of which contribute to this effect.
Dr. Katherine Keyes, a professor at Columbia University Mailman School of Public Health, said there is evidence that these factors may occur to varying degrees in different population groups, making them difficult to identify in population samples. Substance use epidemiology.
Therefore, based on the broader scientific literature, it seems far-fetched that a commercially developed genetic test for OUD might have the effectiveness needed to truly advance clinical practice, she said. If you just ask people, do you have a family history of addiction? I’m assuming this would be a better risk classifier than genetic testing.
Even asking a patient about their history of drug use, particularly tobacco use, can be just as insightful, Saxon said.
If there is overreliance on genetic testing, false negative results from the tests may make patients and their providers feel overly secure about their risk for opioid use disorder, while false positives may limit patients’ access to helpful medications.
This risk-benefit analysis was at the center of discussions about the test at an October 2022 FDA advisory committee meeting, with the independent panel ultimately recommending against the test in an 11-2 vote.
The FDA subsequently worked with AutoGenomics to modify the test. Terms of the new approval require the company to provide training to health care providers on the proper use of the test and conduct a large study to evaluate post-market performance and report progress regularly.
Shuren said information from the test may help patients who are concerned about taking opioids to treat acute pain make more informed decisions. This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions.
According to recent survey data from the U.S. Department of Health and Human Services, approximately 6 million people ages 12 and older will have an opioid use disorder in the United States by 2022. Drug overdose deaths have surged in recent years, with about three-quarters involving opioids. More than 83,000 people died from opioid overdoses last year, according to the Centers for Disease Control and Prevention.
‘I still think prescription opioids remain a prominent risk factor for opioid use disorder,’ Case said. I just encourage clinicians to look at the literature and make sure they’re comfortable with the safety level of the product.
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