Truvian Health bags FDA clearance for CBC on TruVerus System

TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample

In what could transform routine blood testing, Truvian Health, the diagnostics company, has announced that the US FDA has cleared the Complete Blood Count (CBC) test on its TruVerus multi‑modal blood testing system. 

"With CBC now cleared, TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample, reducing the need for multiple tubes, instruments, and fragmented workflows." 

The CBC is the most commonly ordered routine blood test in the United States, with more than 400 million tests performed annually, making it a critical step toward widespread adoption across health systems, physician offices, and decentralized care settings. 

“FDA clearance of CBC represents a significant platform advancement for Truvian,” said Dena Marrinucci, Chief Operating Officer and Co-Founder of Truvian Health.  

“From the outset, our focus has been on building a system that meets the performance expectations of routine clinical care. With CBC now cleared, TruVerus is the only FDA-cleared, multi‑modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample, reducing the need for multiple tubes, instruments, and fragmented workflows. Achieving this required deep technical rigor, disciplined science, and a systems-level approach, and our team executed against that bar.” 

With the addition of CBC, TruVerus now offers 26 FDA‑cleared assays in less than two months. 

“CBC is among the most important evaluations for clinical decision making from routine to complex care,” said Michael Mina, Chief Medical and Strategy Officer at Truvian Health.  

“Bringing CBC onto TruVerus in a single tube-format unlocks comprehensive testing for near-patient care and fundamentally shifts how we think of what is possible for the future of laboratory medicine. This clearance redefines how routine testing can be delivered and moves us toward a future where care is designed around the patient, unlocking new patient-first models of care.” 

“With over two dozen FDA-cleared analytes now in hand, and a first-of-its-kind instrument, we remain focused on advancing TruVerus through continued menu expansion and commercialization,” Marrinucci added. “As we continue to expand the TruVerus menu, we remain committed to working collaboratively with the FDA to bring additional capabilities to market in a thoughtful, data driven way.”