SOLVD Health Receives FDA PMA Supplement Approval for Use of INFINITI High-Throughput System with AvertD®

SAN DIEGO–(BUSINESS WIRE)–SOLVD Health, a patient intelligence company developing cutting-edge precision solutions to deliver better health outcomes, has received U.S. Food and Drug Administration (FDA) PMA supplement approval for its INFINITI High Throughput System (HTS) to be used with AvertD^®.

The HTS instrument expands daily processing capacity, designed to work seamlessly with SOLVD Health’s entire test portfolio, including AvertD^®, the first FDA-approved genetic test for assessing elevated risk for developing opioid use disorder (OUD). The development marks a major advancement in SOLVD Health’s ability to deliver critical health insights at scale.

“This system is about more than increasing output. It’s about amplifying our impact,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “With the HTS, we’re enabling access to cutting-edge genetic insights and opening new possibilities for personalized medicine and preventive health care.”

The HTS underwent rigorous FDA evaluation to ensure it produces results consistent with the organization’s already approved INFINITI PLUS Analyzer. The HTS is a semi-automated, scalable, and multiplexed microarray analysis system that increases throughput to 960 samples in approximately 8 hours compared to 48 samples on the INFINITI PLUS. This efficiency, combined with the cost-effective and readily available DNA processing equipment, significantly enhances workflow optimization.

“This approval underscores our commitment to innovation and clinical excellence,” added Dr. Donaldson. “We’re poised to make a broader impact on critical health issues, including the opioid crisis, by making advanced genetic insights more accessible to health care providers and patients.”

The approval marks another milestone in SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and health care providers to make more informed health decisions.

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