AvertD is an FDA-approved genetic test that uses advanced scientific techniques to identify individuals at higher genetic risk for developing opioid use disorder (OUD)1. By analyzing DNA, the test detects 15 specific genetic polymorphisms that may be linked to an increased susceptibility to OUD, including variations in genes related to serotonin, dopamine, and opioid receptors such as the 5-HTR2A, COMT, DRD1, DRD2, and OPRM1 genes. These genetic markers influence how individuals respond to pain and opioid medications.
The test is a qualitative genotyping procedure performed using a simple buccal (cheek) swab to collect DNA. The sample undergoes DNA extraction, PCR amplification, and microarray analysis, which allows for precise identification of genetic variants associated with a higher risk for developing OUD. These results may assist healthcare providers in the assessment of a patient’s genetic predisposition before prescribing oral opioids for short-term pain management, such as in preparation for a surgical procedure.
By incorporating genetic risk factors into clinical evaluations, healthcare providers can make more informed decisions regarding opioid prescriptions. This proactive approach is especially valuable for patients aged 18 and older who are about to receive their first prescription for oral opioids, typically for 4-30 days. It enables the personalization of treatment plans, considering genetic risk factors alongside other clinical elements, which can help reduce the likelihood of opioid misuse and dependency.
The clinical performance of AvertD was assessed in a blinded, multi-center study involving 381 patients who self-reported their initial exposure to opioids between 1 and 51 years prior to sample collection. All participants had used oral opioids for 4 to 30 days, and their risk for OUD was evaluated at least one year after their exposure. Among those who tested positive for OUD, the test correctly assigned an Elevated Genetic Risk score to 82.8% of patients (95% CI: 76.3 – 88.1%). Among those who did not develop OUD, the test correctly assigned a Non-Elevated Genetic Risk score to 79.2% of patients (95% CI: 73.1 – 84.5%)2.
An “Elevated Genetic Risk” result suggests that the patient’s genomic DNA contains genetic polymorphisms linked to a higher risk of developing OUD after using oral opioids. Patients with Elevated Genetic Risk were found to be 18 times more likely to develop OUD compared to those with a Non-Elevated Genetic Risk3.
This test represents a significant advancement in addiction prevention and pain management, allowing healthcare professionals to identify individuals genetically predisposed to opioid use disorder. This enables the implementation of alternative pain management strategies or closer monitoring if opioids are necessary, marking a major step forward in addressing the opioid crisis and promoting safer, more tailored approaches to pain management.
There are numerous factors associated with an increased risk for developing opioid use disorder, both genetic and non-genetic. While the test assesses the genetic component, it does not account for non-genetic factors, which can also play a significant role in OUD risk. These factors can include environmental influences, personal history, mental health conditions, and socioeconomic factors, among others. The interactions between these various factors are not yet fully understood, which means that genetic risk alone may not provide a complete picture. Therefore, this genetic test is designed to be used as part of a broader clinical evaluation and risk assessment for OUD, helping healthcare providers consider a range of elements when determining an individual’s overall risk. The actual likelihood of developing OUD may vary depending on other personal factors not reflected in the genetic analysis provided by the test.
Citations
1. U.S. Food and Drug Administration. “FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder.” U.S. Food and Drug Administration, 19 Dec. 2023, https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-approves-first-test-help-identify-elevated-risk-developing-opioid-use-disorder.
2. EM-24069 AvertDâ„¢ Package Insert 02 FEB-2024
3. Donaldson K, Cardamone D, Genovese M, Garbely J, Demers L. Clinical Performance of a Gene-Based Machine Learning Classifier in Assessing Risk of Developing OUD in Subjects Taking Oral Opioids: A Prospective Observational Study. Ann Clin Lab Sci July-August 2021 vol. 51 no. 4 451-460
