FDA PMA Supplement Approval Granted to SOLVD Health for Microarray Analysis System

SOLVD Health has gained 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 and works seamlessly with the company’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,” SOLVD Health Founder/CEO Dr. Keri Donaldson said. “With the HTS, we’re enabling access to cutting-edge genetic insights and opening new possibilities for personalized medicine and preventive healthcare.”

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 eight hours compared to 48 samples on the INFINITI PLUS. This efficiency, combined with the DNA processing equipment, significantly enhances workflow optimization, according to SOLVD Health.

“This approval underscores our commitment to innovation and clinical excellence,” Dr. Donaldson added. “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.”

SOLVD Health is a privately held Carlsbad, Calif.-based 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.