AvertD, a genetic test designed to detect which people are at heightened risk of opioid use disorder (OUD), has sparked controversy within medical circles. Despite its recent approval by the FDA, a coalition of 31 healthcare professionals and researchers is urging a reconsideration of its validity and potential implications. They say the test causes false positives and negatives and should be pulled from the market immediately, according to the Washington Post.

Scientists’ Concerns About Genetic Test

The primary concern surrounding AvertD lies in its susceptibility to producing false-negative and false-positive results. These inaccuracies, identified during FDA evaluations, raise significant doubts about the test’s reliability and effectiveness.

False negative and false positive results in genetic tests designed to discern the risk of addiction can have profound implications for patients, healthcare providers, and the healthcare system as a whole. 

The Danger of False Negatives in OUD Genetic Testing

A false negative result, indicating a low risk of addiction when the risk is present, can lead to a false sense of security. It could cause people to underestimate their susceptibility to addiction and engage in risky behaviors, such as substance misuse or excessive use of opioids, without appropriate precautions. 

A false negative could delay or prevent addicted people from receiving timely interventions and support services to address addiction risk factors, potentially allowing addictive behaviors to progress unchecked. 

The Danger of False Positives in OUD Genetic Testing

False positive results, indicating a high risk of addiction when the risk is low, can lead to unnecessary anxiety, stigma, and limitations on treatment options. People with false positive results may be unfairly labeled as having a predisposition to addiction, leading to discrimination and barriers to accessing certain healthcare services. 

Provider bias can also cause poor healthcare outcomes. With false positives, healthcare providers may feel obligated to withhold or limit opioid prescriptions for people who may genuinely require them for pain management. Because of this, false results could cause people to live with untreated pain and reduced quality of life, especially for patients undergoing surgery or other medical procedures.

The biases and harms associated with false negative and false positive results in addiction risk genetic testing underscore the importance of ensuring the accuracy and reliability of such tests. 

Expert Opinions: Pull the Test 

Dr. Andrew Kolodny, an eminent authority on opioid policy, has been vocal in his criticism of AvertD. He argues that the test’s deficiencies extend beyond mere technical limitations and asserts its potential to mislead patients and clinicians.

Various genetic, environmental, and social factors can influence opioid addiction. People with a family history of substance abuse, a personal history of mental health disorders, or chronic pain conditions are at heightened risk of developing OUD.

The Coalition’s Appeal 

In letters addressed to FDA Commissioner Robert Califf and CMS Administrator Chiquita Brooks-LaSure, the coalition highlights the inadequacies of AvertD’s methodology and calls for its reconsideration. They argue that the test’s approval could harm patient care and public health.

SOLVD Health, the company behind AvertD, acknowledges and pledges to review the coalition’s concerns. They maintain that AvertD represents a significant advancement in opioid risk assessment and emphasize the importance of ongoing research to validate its utility in clinical practice.

The Role of Genetic Testing Remains Debatable

While genetic testing holds promise in identifying predispositions to certain medical conditions, its efficacy in predicting OUD risk remains uncertain. 

Confounding factors, such as ancestry and environmental influences, can significantly impact the accuracy of genetic predictions.

As AvertD discussions continue, healthcare professionals must prioritize patient safety and evidence-based practice. While genetic testing holds promise in healthcare, rigorous evaluation and scrutiny are essential to ensure its responsible and effective use in addressing the complex challenges of opioid addiction.

Science-Backed OUD Test Methods

While no genetic tests or other blood tests can predict addiction, several scientifically backed tests and assessments can diagnose Opioid Use Disorder (OUD). Here are some common ones:

  • DSM-5 Criteria: Professionals use this standard guide, the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), to diagnose Opioid Use Disorder (OUD). It outlines specific symptoms such as unsuccessful attempts to cut down or control opioid use, craving opioids, and continued use despite social or interpersonal problems.
  • ASI: The Addiction Severity Index (ASI) is a structured interview used to assess various aspects of an individual’s life affected by substance use. It covers domains such as medical status, employment, legal issues, psychiatric status, and social relationships, providing a comprehensive understanding of the impact of substance use on the person’s life.
  • ODS: The Opioid Dependence Scale (ODS) is a tool used to measure the severity of opioid dependence. It evaluates criteria such as tolerance (needing higher doses to get the same “high”), withdrawal symptoms when a person can’t use opioids, and loss of control over opioid use, helping healthcare providers assess the level of dependence and plan appropriate treatment.
  • COWS: The Clinical Opiate Withdrawal Scale (COWS) is a tool for clinicians to evaluate the severity of opioid withdrawal symptoms. It assesses common withdrawal symptoms such as sweating, anxiety, gastrointestinal distress, and tremors.
  • SASSI: The Substance Abuse Subtle Screening Inventory (SASSI) is a self-report tool designed to identify individuals at risk for substance use disorders, including OUD. It includes questions that assess various aspects of substance use behavior and consequences, providing insight into the individual’s risk level and informing further assessment or intervention.
  • Drug testing: Drug screening involves testing biological samples such as urine, blood, or hair to detect the presence of opioids and other substances. It provides objective evidence of recent substance use, such as evidence a person has used fentanyl, and helps healthcare providers confirm suspected substance use disorders.
  • SCID: The Structured Clinical Interview for DSM (SCID) is a widely used diagnostic tool for psychiatric disorders, including substance use disorders like OUD. It involves a structured interview format that follows DSM criteria.

These tests and assessments are often combined to provide a comprehensive evaluation of an individual’s substance use and related problems.

Some healthcare providers may consider other factors, such as medical history, family history, and social context, when diagnosing OUD.

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