SOLVD Health Receives New York State Laboratory Approval

SOLVD Health has received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for its San Diego-based laboratory. This approval authorizes SOLVD Health to offer AvertD^® for patients in New York, empowering healthcare providers and patients with critical insights to help mitigate the risk of opioid use disorder (OUD).

The New York State Department of Health is recognized for its rigorous standards in clinical laboratory testing, ensuring that approved laboratories meet high benchmarks for accuracy, reliability, and patient safety. SOLVD Health’s AvertD^®genetic test, already FDA-approved, is designed to assess individual genetic susceptibility to OUD, providing valuable information to guide personalized pain management strategies.

“Securing New York State approval is a pivotal step in our mission to expand access to genetic testing that can help address the opioid crisis,” said SOLVD Health founder and CEO Dr. Keri Donaldson. “This expansion enables more healthcare providers and patients to benefit from personalized health insights that can inform decisions about pain management and potentially prevent adverse outcomes.”

As the healthcare industry continues to seek solutions to combat the ongoing opioid epidemic, AvertD offers clinically validated genetic insights that can help them advise pain management decisions before opioid therapy begins. This approval advances SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and healthcare providers to make more informed health decisions.

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

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

SOLVD Health Launches 5-Year Post-Approval Study on Real-World Impact for AvertD^® Genetic Test

SOLVD Health has launched a comprehensive post-approval study for AvertD^®, the first U.S. Food and Drug Administration (FDA)-approved genetic test for assessing risk of developing opioid use disorder (OUD). This post-approval study aims to expand upon pivotal study findings and further demonstrate AvertD’s ability to enhance personalized data-driven decisions in real-world settings.

The prospective study will enroll up to 4,000 patients, integrating agile methods to gather comprehensive, real-world data from diverse demographic groups across the United States. Designed to confirm AvertD’s predictive accuracy across diverse populations, the study seeks to equip providers with critical insights for individualized, evidence-based pain management.

“The launch of our post-approval study for AvertD represents more than our commitment to regulatory requirements. It’s a commitment to addressing one of the most pressing public health challenges of our time,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “Every day, healthcare providers and their patients face challenging decisions about pain management. Our goal is to arm them with precise, personalized insights to guide these critical decisions and improve patient outcomes.”

The study will follow participants for up to five years, providing additional long-term data on the predictive value of genetic testing in OUD risk assessment. The extended timeframe will enable researchers to observe how genetic risk factors interact with environmental and behavioral influences over time, potentially uncovering new strategies for addiction prevention and intervention.

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