On Tuesday, the U.S. Food and Drug Administration (FDA) announced its approval of the first-ever test designed to evaluate the potential risk of addiction to opioid use in specific individuals. This test, known as AvertD, has been developed by SOLVD Health, a privately held company. The FDA approved AutoGenomics, a unit acquired by SOLVD Health in 2019.

AvertD is a test specifically intended for use prior to the initial consumption of oral opioid painkillers, especially for individuals who are being considered for a prescription lasting between 4 to 30 days to manage acute pain. This typically includes patients scheduled for planned surgical procedures.

What is the Opioid Addiction Risk Test Like?

This genetic laboratory test, available only with a prescription, is designed for individuals aged 18 and older who have not previously used oral opioid painkillers. The procedure involves swabbing the patient’s cheek to collect a DNA sample. This sample is then analyzed to identify any combination of genetic variants that might be linked to an increased risk of developing opioid use disorder.

The misuse of opioid painkillers has contributed to a widespread opioid epidemic in the United States, resulting in over half a million overdose deaths spanning more than two decades. AvertD aims to address this issue by identifying individuals who may be more susceptible to developing opioid use disorder with their test.

To provide some context, an advisory panel to the health regulator convened in October of the previous year to discuss an earlier version of the AvertD test. The approval of this test marks a significant step in addressing the challenges posed by opioid addiction and represents a proactive measure in mitigating the risks associated with opioid use.

Test Not Good Predictor for Chronic Pain Patients

However, it’s important to clarify that AvertD is not intended for use in patients undergoing chronic pain treatment, as the FDA highlighted. Chronic pain management often requires different considerations, and this test is tailored for those facing acute pain situations.

There are several reasons why a test like AvertD might not be suitable for chronic pain patients. Chronic pain conditions often have a more complex and varied etiology compared to acute pain. Genetic factors contributing to chronic pain can differ significantly from those associated with acute pain. Chronic pain can often affect all parts of a person’s life when it’s uncontrolled. They also develop a dependency even without an addiction. A test designed for acute pain may not accurately predict the risk of opioid use disorder in chronic pain scenarios.

Chronic pain management often involves the long-term use of opioid medications. AvertD is specifically designed for individuals who have not previously used oral opioid painkillers and for short-term prescriptions (4 to 30 days). Its effectiveness and relevance may diminish when applied to individuals using opioids on a more prolonged basis. This test cannot predict anything having to do with chronic pain, which requires nuance and input from the doctor treating the patient.

A range of psychosocial factors, such as mental health, stress, and environmental factors, also influence chronic pain. AvertD focuses on genetic variants but does not account for these broader influences on chronic pain and opioid use disorder.

Potential for Bias Based on Creators of Test

Regarding bias, the test could introduce biases based on population genetics. If the test was primarily developed and validated on a specific population, such as only caucasian people, its accuracy might vary when applied to individuals from different ethnic or genetic backgrounds. This could result in a lack of inclusivity and accuracy for certain demographic groups.

The test might not account for the interplay between genetic factors and environmental influences, leading to an incomplete understanding of an individual’s risk. It’s essential to recognize the limitations of genetic testing and consider it as part of a broader approach to assessing the risks of opioid use disorder.