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

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.

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health’s Pharmacogenomics Test Receives New York State Department of Health Approval

Pharmacogenomic testing plays a critical role in precision medicine, helping clinicians tailor drug therapies based on an individual’s genetic profile. By identifying genetic variations that influence drug metabolism and response, PGx testing empowers providers to optimize treatment plans, reduce adverse drug reactions, and improve patient outcomes.

“Approval from the New York State Department of Health underscores our commitment to delivering actionable insights that transform healthcare,” said Dr. Keri Donaldson, Founder and President of SOLVD Health. “Pharmacogenomics is a cornerstone of personalized medicine, and this clearance allows us to expand access to tools that help clinicians make safer, more effective prescribing decisions.”

This achievement builds on SOLVD Health’s proven track record of innovation, including its FDA-approved AvertD® test, the first genetic test designed to assess elevated risk for opioid use disorder prior to prescribing oral opioids. Leveraging AI-powered analytics and proprietary algorithms, SOLVD Health continues to advance its mission of preventing disease and improving health outcomes through predictive, personalized insights.

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.

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

Media Contact:
Katie Kennedy
Gregory
solvd@gregoryfca.com

SOLVD Health Publishes Peer-Reviewed Framework to Advance Clinical Use of Genomic Data

Co-authored by SOLVD Health scientists in collaboration with San Raffaele Roma Open University and CEINGE–Biotecnologie Avanzate in Naples, Italy, the article, “Establishing Best Practices for Clinical GWAS: Tackling Imputation and Data Quality Challenges,” directly supports the scientific foundation behind AvertD, SOLVD Health’s FDA-approved genetic test for assessing the risk of developing opioid use disorder (OUD). As AvertD expands its clinical reach, the standards outlined in this paper demonstrate the rigor behind its development and the company’s commitment to responsible innovation in genomic medicine.

“There is a growing need to establish clear standards around the preparation and use of genomic data,” said Dr. Keri Donaldson, Founder and President of SOLVD Health. “This work brings those standards into focus and supports more consistent, reliable application of genetic information in clinical settings.”

“Genotype imputation is crucial for translating GWAS discoveries into actionable clinical insights,” said Dr. Valeria D’Argenio, Professor at San Raffaele Roma Open University and CEINGE–Biotecnologie Avanzate Principal Investigator and Head of Molecular Diagnostics. “By defining a rigorous, evidence-based framework spanning quality control, cross-population validation and ethical equity, we provide the community with a clear road map for minimizing error, maximizing reproducibility and ensuring that the benefits of precision medicine reach all patient populations.”

The article outlines best practices for clinical GWAS implementation, including: direct genotyping of clinically actionable variants, transparent reporting of imputation quality metrics, cross-population validation, ancestry-matched reference panels, rigorous quality control, ethical and equity safeguards, and global collaboration.

“We are committed to setting a high bar for how genetic insights are used in medicine,” said Dr. Donaldson. “This article reflects this notion and reinforces the foundation on which AvertD was developed, and how we approach every solution we bring into clinical practice.”

Read the full article: Establishing Best Practices for Clinical GWAS: Tackling Imputation and Data Quality Challenges

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.

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

Media Contact:
Katie Kennedy
Gregory
solvd@gregoryfca.com

SOLVD Health Advances Development of Novel Test to Optimize GLP-1 Therapeutic Response

SOLVD’s focus on brain reward pathways is central to this development, which enables insights into the genetic underpinnings of both metabolic conditions and behavioral health. Powered by advanced AI algorithms, this approach leverages genetic markers and clinical records associated with GLP-1 to help healthcare providers identify patients most likely to respond to GLP-1 therapies, potentially transforming treatment protocols for a condition that affects one in eight people globally, while advancing the understanding of how these neural pathways influence a range of health conditions.

Building on the success of AvertD, the first and only FDA-approved genetic test for assessing the genetic risk of developing Opioid Use Disorder, which also targets the brain’s reward pathways, SOLVD’s GLP-1 therapeutic approach benefits from similar mechanisms. AvertD’s FDA PMA approval serves as a precedent, providing a platform that can be leveraged to enhance the clinical adoption and regulatory submission of GLP-1-based solutions for metabolic and behavioral health.

“As the worldwide prevalence of obesity and type 2 diabetes continues to grow, the need for more targeted, personalized treatment methods becomes increasingly critical,” said SOLVD Health Founder and President Dr. Keri Donaldson. “Our diagnostic technology aims to bring precision medicine to GLP-1 therapies to help healthcare providers optimize treatment outcomes and reduce unnecessary costs.”

“By examining the genetic underpinnings of GLP-1 therapeutic response, we’re creating a tool that could fundamentally change how we address obesity and type-2 diabetes treatments,” added Dr. Donaldson. “This technology can improve patient selection criteria, enhancing clinical trial efficiency and commercializing targeted therapies.”

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.

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

Media Contact:
Katie Kennedy
Gregory
solvd@gregoryfca.com

SOLVD Health Appoints Mike Aicher and Vince Cebula to Board of Directors to Support Next Phase of Growth

May 12, 2025 —  SOLVD Health has appointed diagnostics pioneer Mike Aicher and strategic advisor Vince Cebula to its Board of Directors. Their combined leadership in molecular diagnostics, healthcare technology, and growth-stage investment will support the company’s continued expansion as it scales access to personalized health insights and accelerates development of its precision diagnostics platform.

Aicher’s expertise in building and scaling diagnostic platforms will be instrumental as SOLVD Health expands its personalized health solutions. He brings more than three decades of executive experience in genomics, laboratory medicine, and diagnostics innovation. He co-founded and served as CEO of the National Genetics Institute (NGI) — acquired by Labcorp (NYSE: LH) — where he later led the company’s Esoteric Business Units, which generated over $1 billion in annual revenue. He currently serves as Executive Chairman of SemiconBio and on the board of Genetic Signatures (ASX: GSS) and Techcyte. He holds a bachelor’s degree in business administration from the University of Redlands and is a certified Global Biotechnology Executive from the University of California, Berkeley. He also received Ernst and Young’s “Entrepreneur of the Year” award for emerging technologies.

Cebula’s deep financial acumen and board leadership will help guide SOLVD Health’s expansion and long-term sustainability. An accomplished investor and advisor with extensive experience in private equity, investment banking, and operational transformation, he was a senior asset management executive focused on providing capital to lower middle market companies in the United States and Canada and has served on over fifteen private and public company boards. Cebula has held senior roles at Oaktree Capital Management, Jefferies Capital Partners, and Drexel Burnham Lambert, with a focus on strategic growth and value creation, and graduated from The Wharton School of The University of Pennsylvania.

“As we advance the next phase of our mission — bringing personalized, precision insights to more patients and providers — Mike and Vincent bring the experience and strategic vision to help us scale our impact,” said Dr. Keri Donaldson, Founder and CEO of SOLVD Health. “Mike’s contributions to diagnostics innovation and Vincent’s financial and operational leadership will be instrumental as we grow our platform and deepen our ability to deliver better health outcomes through data.”

These board appointments come at a pivotal time for SOLVD Health as it advances its proprietary diagnostics platform, including the FDA-approved AvertD^® test for assessing the genetic risk of opioid use disorder (OUD). With Aicher and Cebula’s assistance, the company is well-positioned to deepen its clinical impact, expand strategic partnerships, and further its mission to prevent disease through data-driven, patient-centered innovation.

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.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com