On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee We will meet To discuss AvertD, a prescription for genetic risk assessment for opioid use disorder (OUD).
AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It is intended to be used in conjunction with clinical assessments and patient assessments when oral prescription opioid medications are being considered for the treatment of acute pain.
device is offline It is marketed to physicians and their patients It is paid for either by insurance or directly by the patient in the amount of $199.
Currently, no FDA-approved or approved devices have been indicated for the determination of genetic risk for OUD. A version of AvertD with 11 of the 15 SNPs now included in the device was awarded a Breakthrough Device designation by the Food and Drug Administration in March 2018.
Recently, the device has been evaluated in multiple sites Observational study which evaluated 385 people after their initial exposure to oral prescribed opioids.
The FDA Rejected Initial SOLVD de novo classification AvertD applied in August 2021. This decision was upheld on appeal in January. In June, SOLVD reinstated a de novo request after collecting additional information about study participants to respond to FDA concerns.
Now, the FDA is seeking input from its advisory panel before making its final decision.
SOLVD reported overall study results showing a sensitivity of 82.76% (95% CI 76.31-88.05) and a specificity of 79.23% (95% CI 73.06-84.54). “However, there are many factors that influence the interpretation of test performance and increase uncertainty about the applicability of the observed clinical study test results to the intended use population,” the FDA wrote in its report. Briefing documents before the meeting.
The agency noted that “a device that detects genetic variants that may be associated with OUD could be useful in combating the opioid epidemic.”
But genetic risk may not be the biggest factor in predicting OUD risk, the FDA noted, noting that “the genetic associations of individual candidate genes identified to date only explain a small portion of the risk of OUD.” Additionally, many individuals with risk factors may never develop the disease, the Food and Drug Administration says.
Unlike risk assessment tools for chronic pain that include routine screening such as patient history questionnaires and urine drug tests, genetic testing may have various emotional ramifications and associated stigmas, the FDA noted. The agency said the risks associated with false-positive and false-negative results should be taken into account.
The FDA added that research studies have also indicated that the 15 SNPs detected by AvertD are not specific to OUD and may be associated with many other addiction and mood disorders.
But the overarching question that will be put to the advisory panel on Thursday will focus on the clinical study and whether study participants adequately represent the intended use category. The FDA has expressed a number of potential concerns, including discrepancies in the case report forms used to collect study data, confidence that the study completely excluded subjects whose index of exposure to oral opioids was either illicit or for the treatment of chronic pain, and demographic makeup – Race, ethnicity, age and gender – for the participants.
in their documents before the meeting, SOLVD addressed these points and provided additional analyzes to support that the results of the AvertD study apply to the intended use population.
SOLVD also notes that prescribing guidelines require individual benefit risk assessments to determine if opioids are appropriate for acute pain management.
“Thus, AvertD fits into the current clinical flow, with the main benefits being providing information to patients and providers to make more informed choices about opioid prescribing for acute pain,” the company wrote.