The U.S. Food and Drug Administration (FDA) has taken action against the opioid crisis by approving the first DNA-based test to assess the risk of developing opioid use disorder (OUD). The AvertD test, developed by AutoGenomics, is a tool designed to identify genetic risk factors associated with OUD, which could be important in preventing the disorder. This approval comes after an initial setback when the FDA’s Medical Devices Advisory Committee voted against an earlier version of the test in October 2022. The committee had raised concerns about the test’s safety and efficacy, leading to a 2-11 vote against it. However, AutoGenomics revised the test and submitted a new application, addressing the committee’s feedback. This proactive approach by AutoGenomics and the FDA’s willingness to reevaluate the revised test illustrates the volotile nature of medical device approval processes and the importance of regulatory flexibility in response to scientific advancements and feedback.
The AvertD test operates by using a DNA sample obtained from a cheek swab, administered by a healthcare provider. The test analyzes the DNA for specific genetic variants that may indicate an elevated risk of developing OUD. This approach represents an advancement in personalized medicine, allowing for a more refined assessment of a patient’s risk factors. It is intended for use in adult patients, specifically those being considered for a short-term (4-30 day) opioid prescription for acute pain, such as in preoperative settings. The test is not intended for chronic pain patients or those who have already been exposed to oral opioid analgesics.As part of the approval process, the FDA has mandated that AutoGenomics provide extensive training to healthcare providers on the correct use of the test. Additionally, the company is required to conduct a comprehensive post-market study to assess the test’s performance in a real-world setting. The study was required in evaluating the test’s effectiveness and ensuring its responsible deployment in clinical practice. AutoGenomics must also regularly report the study’s progress to the FDA, ensuring ongoing oversight and evaluation of the test’s impact and utility.
The primary risks associated with the AvertD test are false negatives and false positives. A false negative result could lead to a mistaken sense of security, potentially resulting in the prescription of opioid analgesics to a patient at increased risk of OUD. On the other hand, a false positive result might lead to inadequate pain management, as healthcare providers might avoid prescribing opioids to patients who could safely benefit from them. It would seem important that the test results are used in conjunction with a comprehensive clinical evaluation and risk assessment, rather than as the sole basis for treatment decisions.
The AvertD test represents a unique approach to addressing the opioid crisis by providing a tool to assess the genetic predisposition to OUD. Its approval by the FDA shows agency is commited to combating the opioid epidemic through innovative medical technologies. The test’s development and subsequent approval also portray the importance of collaborative efforts between regulatory bodies and medical device manufacturers in advancing healthcare and addressing public health challenges. As mentioned, it is vitally important to identify that the test is one component of a broader strategy required to effectively manage and prevent OUD. Its use must be integrated into a holistic approach to patient care, considering various clinical and psychosocial factors that contribute to the risk of opioid misuse and addiction.
