{"id":396233,"date":"2023-12-21T10:12:35","date_gmt":"2023-12-21T15:12:35","guid":{"rendered":"https:\/\/platohealth.ai\/fda-approves-first-test-to-spot-folks-at-high-risk-of-opioid-use-disorder-drugs-com-mednews\/"},"modified":"2023-12-26T00:42:40","modified_gmt":"2023-12-26T05:42:40","slug":"fda-approves-first-test-to-spot-folks-at-high-risk-of-opioid-use-disorder-drugs-com-mednews","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-approves-first-test-to-spot-folks-at-high-risk-of-opioid-use-disorder-drugs-com-mednews\/","title":{"rendered":"FDA Approves First Test to Spot Folks at High Risk of Opioid Use Disorder – Drugs.com MedNews","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

Medically reviewed by Carmen Pope, BPharm<\/a>. Last updated on Dec 21, 2023.<\/span><\/p>\n

By Dennis Thompson HealthDay Reporter<\/p>\n

THURSDAY, Dec. 21, 2023 — A newly approved test can determine whether a person has a genetically driven risk of becoming addicted to opioids.<\/p>\n

The AvertD test, the first of its kind, uses a DNA sample swabbed from a patient\u2019s cheek to determine if they have a combination of genetic variants associated with an elevated risk of opioid addiction.<\/p>\n

The 15 genetic variants detected by the test are involved in the brain reward pathways that are associated with opioid use disorder<\/a>, the U.S. Food and Drug Administration explained.<\/p>\n

\u201cThe 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,\u201d Dr. Jeff Shuren<\/a>, director of the FDA\u2019s Center for Devices and Radiological Health, said in a statement<\/a> announcing the approval.<\/p>\n

The AvertD test, manufactured by AutoGenomics Inc., is meant to help doctors assess the risk of prescribing opioid painkillers to patients about to undergo surgery, the FDA said.<\/p>\n

The test is prescription-only, and is to be used with a patient\u2019s consent if they have no prior use of opioids, the FDA added.<\/p>\n

The FDA noted that the test isn’t intended to be used in patients being treated for chronic pain, and should not be used as the sole way to assess a person\u2019s risk of opioid addiction.<\/p>\n

\u201cAvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,\u201d Shuren said.<\/p>\n

The approval is based on a clinical trial involving 385 people, according to materials<\/a> from an October 2022 advisory committee meeting evaluating the test\u2019s merits. Of those participants, 175 had a diagnosed opioid use disorder.<\/p>\n

The AvertD test accurately detected those at risk of opioid addiction about 83% of the time, results showed. It accurately ruled out those not at risk about 80% of the time.<\/p>\n

However, test accuracy varied between ethnicities. The AvertD test accurately detected risk of opioid addiction about 81% of the time in whites, but nearly 92% of the time in Hispanics.<\/p>\n

The FDA also noted that there are risks associated with the AvertD test, mainly false negative and false positive results.<\/p>\n

A false positive could lead to a person being denied opioid painkillers even though they have no elevated genetic risk for addiction, the FDA said. <\/p>\n

Meanwhile, a false negative could lead to someone becoming addicted because the test indicated they weren\u2019t at increased risk for opioid use disorder.<\/p>\n

\u201cThe risks of false negative and false positive results can be mitigated, in part, through accurate, transparent product labeling and a health care provider training program,\u201d Shuren said.<\/p>\n

As part of the approval, AutoGenomic must provide training to health care professionals to ensure appropriate use of the test, the FDA said.<\/p>\n

Some experts are concerned about the test\u2019s use in clinical practice, given that genetics are only one contributing factor in addiction.<\/p>\n

\u201cIf you just ask people, \u2018Do you have a family history of addiction?\u2019 I would hypothesize that that would be a better risk categorizer than this genetic test,\u201d Dr. Katherine Keyes<\/a>, a professor at the Columbia University Mailman School of Public Health in New York City, told CNN<\/em>.<\/p>\n

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Sources<\/h2>\n