FDA Approves DNA Cheek Swab Test to ID Patients at High Risk for Opioid Addiction
By Physician’s Briefing Staff HealthDay Reporter
THURSDAY, Dec. 21, 2023 -- The U.S. Food and Drug Administration has approved a first-of-its-kind test -- the AvertD test -- that uses DNA swabbed from a patient's cheek to determine if they have a combination of genetic variants associated with an elevated risk for opioid addiction.
The 15 genetic variants detected by the test are involved in the brain reward pathways that are associated with opioid use disorder, the FDA explained.
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. The test is prescription-only and is to be used with a patient's consent if they have no prior use of opioids. The FDA noted that the test is not intended to be used in patients being treated for chronic pain and should not be used as the sole way to assess a person's risk for opioid addiction.
The approval is based on a clinical trial involving 385 people, according to materials from an October 2022 advisory committee meeting evaluating the test's merits. Of those participants, 175 had a diagnosed opioid use disorder. The AvertD test accurately detected those at risk for opioid addiction about 83 percent of the time, results showed. It accurately ruled out those not at risk about 80 percent of the time. However, test accuracy varied between ethnicities. The AvertD test accurately detected risk for opioid addiction about 81 percent of the time in Whites but nearly 92 percent of the time in Hispanics.
The FDA also noted there are risks associated with the AvertD test, mainly false-negative and false-positive results. 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. Meanwhile, a false negative could lead to someone becoming addicted because the test indicated they were not at increased risk for opioid use disorder.
As part of the approval, AutoGenomic must provide training to health care professionals to ensure appropriate use of the test, the FDA said.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted December 2023
Read this next
Planetary Health Diet Index Linked to Lower Total, Cause-Specific Mortality
MONDAY, June 10, 2024 -- A higher Planetary Health Diet Index (PHDI) is associated with a lower risk for total and cause-specific mortality, according to a study published online...
Prevalence of Iron Deficiency Varies With Different Definitions
MONDAY, June 10, 2024 -- The prevalence of iron deficiency varies significantly with three different definitions, according to a study published online June 7 in JAMA Network...
AI Blood-Based Lung Cancer Screening Test Developed for Fragmentome
MONDAY, June 10, 2024 -- A novel blood-based lung cancer screening test has been developed and validated using genome-wide sequencing to analyze cell-free DNA (cfDNA)...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.