FDA Approves Blood Collection for AvertD Genetic Test to Assess Opioid Use Disorder Risk
核心洞察
SOLVD Health (搜索) received FDA approval to expand AvertD (搜索) sample collection to include venous whole blood, making the first FDA-approved genetic test for opioid use disorder (搜索) risk more accessible to healthcare systems.
AvertD (搜索) analyzes 15 genetic variants to categorize patients as having elevated or non-elevated genetic risk for developing opioid use disorder (搜索) prior to first oral opioid exposure for acute pain (搜索).
The test is indicated for individuals 18 years and older being considered for their first prescription of oral opioids (搜索) for four to 30 days for acute pain (搜索), particularly those scheduled for planned surgical procedures.
SOLVD Health (搜索) announced FDA approval to expand sample collection methods for AvertD (搜索)®, the first and only FDA-approved genetic test indicated to assess genetic risk of opioid use disorder (搜索) (OUD) prior to first exposure to oral opioids (搜索) for acute pain (搜索). The approval allows the test to be performed using either a noninvasive cheek swab or venous whole blood, collected by healthcare professionals in accordance with FDA-approved labeling.
Enhanced Clinical Workflow Integration
The addition of blood-based collection addresses a key barrier to widespread adoption by making it easier for health systems to integrate objective genetic risk information into existing clinical workflows. "Expanding AvertD (搜索) to include blood‑based collection makes it easier for health systems to integrate objective genetic risk information into existing clinical workflows," said Mike Aicher, Executive Director of SOLVD Health (搜索).
AvertD (搜索) is a qualitative genotyping test that analyzes 15 genetic variants and categorizes patients as having either Elevated Genetic Risk or Non-Elevated Genetic Risk for developing OUD. The test results may be used to inform shared decision making regarding opioid selection, dose, duration, and monitoring, without prohibiting opioid use or replacing clinical judgment.
Addressing Healthcare System Challenges
Health systems and insurers face increasing scrutiny around opioid prescribing practices, documentation of patient opioid risk discussions, and compliance with evolving regulatory requirements. AvertD (搜索) provides objective genetic risk information that can be incorporated into pre-operative pathways, anesthesia workflows, utilization management policies, and quality initiatives, particularly for elective procedures where short-term opioid prescribing is anticipated.
"AvertD (搜索) doesn't replace clinical judgment, but it addresses a known limitation in how opioid risk has historically been evaluated by adding an objective genetic dimension to the risk assessment process," Aicher explained. The test helps organizations operationalize genetic risk assessment in a way that is consistent with FDA authorization, supporting patient safety and strengthening the defensibility of opioid prescribing decisions.
Clinical Indications and Limitations
AvertD (搜索) is indicated for use only in individuals 18 years and older who are being considered for a first prescription of oral opioids (搜索) for four to 30 days for acute pain (搜索), such as patients scheduled to undergo planned surgical procedures who consent to testing. The test is not intended for use in patients with chronic pain (搜索), does not diagnose opioid use disorder (搜索), and does not predict individual outcomes.
Test results must always be interpreted alongside clinical evaluation and other patient-specific risk factors. The test is intended to be used as part of a complete patient clinical evaluation and risk assessment that supports healthcare providers, health systems, and payers as they implement individualized, risk-informed prescribing practices aligned with FDA opioid safety labeling and communications.
Laboratory Operations and Availability
AvertD (搜索) testing is performed in SOLVD Health (搜索)'s CLIA-certified and CAP-accredited laboratory and is available nationwide. The company is actively engaging with health systems, anesthesia groups, surgical programs, and payers to support workflow integration, coverage discussions, and responsible adoption of genetic opioid risk assessment.