SOLVD Health Announces FDA Approval to Expand AvertD® Sample Collection to Include Blood, Enabling Broad Availability of the First and Only FDA‑Approved Genetic Test Indicated to Assess Genetic Risk of OUD Prior to First Oral Opioid Prescription

AvertD enables health systems and payers to support FDA-approved labeling instructions for opioid risk assessment and strengthen individualized prescribing decisions

SAN DIEGO--(BUSINESS WIRE)--SOLVD Health, a privately held company focused on preventing disease through actionable and personalized health information, today announced broad availability of AvertD^® following FDA approval to expand sample collection to include venous whole blood. AvertD is the first and only FDA‑approved genetic test indicated to assess genetic risk of opioid use disorder (OUD) prior to first exposure to oral opioids for acute pain.

AvertD is a qualitative genotyping test that analyzes 15 genetic variants and may now be performed using either a noninvasive cheek swab or venous whole blood, collected by a healthcare professional in accordance with FDA‑approved labeling. Results categorize patients as having an Elevated Genetic Risk or Non-Elevated Genetic Risk for developing OUD and may be used to inform shared decision making regarding opioid selection, dose, duration, and monitoring, without prohibiting opioid use or replacing clinical judgment.

The AvertD 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.

"Expanding AvertD 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. “AvertD 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."

Health systems and insurers face increasing scrutiny around opioid prescribing practices, documentation of patient opioid risk discussions, and compliance with evolving regulatory requirements. AvertD provides objective genetic risk information that is straightforward to administer, as it can be incorporated into pre-operative pathways, anesthesia workflows, utilization management policies, and quality initiatives. It is particularly suited for elective procedures where short-term opioid prescribing is anticipated.

“As new, validated tools become available, health systems and payers are re-evaluating how opioid risk is assessed and documented,” Mr. Aicher said. “AvertD helps organizations operationalize genetic risk assessment, in a way that is consistent with FDA authorization, that supports patient safety and strengthens the defensibility of opioid prescribing decisions.”

AvertD is indicated for use only in individuals 18 years and older who are being considered for a first prescription of oral opioids for four to 30 days for acute pain, such as patients who are scheduled to undergo a planned surgical procedure and consent to testing. AvertD is not intended for use in patients with chronic pain, does not diagnose opioid use disorder, and does not predict (or attempt to predict) individual outcomes. Test results should always be interpreted alongside clinical evaluation and other patient-specific risk factors.

AvertD testing is performed in SOLVD Health’s CLIA-certified and CAP-accredited laboratory and is available nationwide. SOLVD Health is engaging with health systems, anesthesia groups, surgical programs, and payers to support workflow integration, coverage discussions, and responsible adoption of genetic opioid risk assessment.

About SOLVD Health
SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about SOLVD Health, visit www.solvdhealth.com.

Important Use Information
AvertD^® is intended to be used as part of a complete clinical evaluation and risk assessment prior to prescribing oral opioids for acute pain. Genetics are only one factor influencing opioid use disorder risk. Clinical judgment and existing guidelines should continue to be followed for all patients.