Truvian Health Receives another FDA Clearance – for Complete Blood Count (CBC) on TruVerus™

Original from: Truvian Health

Truvian Health (“Truvian”), a diagnostics company redefining routine blood testing, today announced U.S. Food and Drug Administration (FDA) clearance for the Complete Blood Count (CBC) on its TruVerus™ multi‑modal blood testing system (K251249).

CBC is the most frequently ordered routine blood test in the United States, with more than 400 million tests performed annually, making it a core requirement for broad adoption across health systems, physician offices, and decentralized care settings.

“FDA clearance of CBC represents a significant platform advancement for Truvian,” said Dena Marrinucci, PhD, 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 has expanded its FDA‑cleared menu to 26 assays in just under two months.

“CBC is among the most important evaluations for clinical decision making from routine to complex care,” said Michael Mina, MD, PhD, 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.”

Source: Truvian Health Receives another FDA Clearance – for Complete Blood Count (CBC) on TruVerus™