SAN DIEGO–(BUSINESS WIRE)–Truvian Health (“Truvian”), a transformational diagnostics company redefining healthcare, today announced it has received 510(k) clearances (K251091, K251074, K251157) from the U.S. Food and Drug Administration (FDA) for nine additional analytes for TruVerus™, the industry’s first FDA cleared multimodal benchtop blood analyzer. The newly cleared tests expand the TruVerus menu into three new key categories: cardiovascular health, liver health, and core metabolic health.
The nine tests comprise many of the most commonly ordered tests including: Total Cholesterol (TChol), Triglycerides (TRIG), Very Low-Density Lipoprotein (VLDL), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP), Albumin (ALB), Total Protein (TP), and Glucose (GLU).
These clearances come on the heels of the landmark November 2025 FDA clearance (K251058) of Truvian’s TruVerus instrument, the industry’s first true multi-modal benchtop analyzer to integrate clinical chemistry, immunoassay and AI-powered hematology testing into a single simultaneous and fully automated workflow, using only microliter volumes of whole blood. That clearance included three foundational analytes for kidney health: creatinine (CRE), BUN, and eGFR. With this latest decision, TruVerus is now cleared for twelve of the most commonly ordered tests across cardiovascular, kidney, liver, and core metabolic health.
This strong cadence of recent clearances reflects Truvian’s intentional, staged regulatory strategy to bring the world’s first comprehensive, multimodal benchtop solution to decentralized testing.
“Receiving these additional clearances so soon after our initial TruVerus authorization is a testament to the rigor of our science and the scalability of our platform,” said Dena Marrinucci, PhD, Co-Founder and Chief Operating Officer of Truvian. “By expanding our menu, we are delivering on our promise to provide a comprehensive, lab-accurate diagnostic solution that removes the delays and complexity of the traditional central lab model. We are dedicated to delivering a full suite of tests that empower providers to make informed decisions in minutes, not days.”
“These additions to the TruVerus platform mark a significant leap forward in proactive and more accessible medicine and health monitoring,” said Michael J. Mina, MD, PhD, and Truvian’s Chief Medical and Strategy Officer. “For too long, the time between a blood draw and a follow-up appointment has hindered patient care. With these new clearances, Truvian is proving that comprehensive lab testing can be decentralized, fast and fully automated without sacrificing the accuracy that clinicians depend on.”
In addition to assays cleared and others currently pending 510(k) clearance, Truvian is progressing a pipeline of new tests to continue expanding the TruVerus menu under its staged regulatory roadmap.
About Truvian
Truvian Health is a transformational diagnostics company redefining healthcare through its FDA‑cleared, multi‑modal blood testing platform. Built on a foundation of scientific integrity and relentless innovation, Truvian empowers providers and patients with convenient, accurate, timely, and comprehensive testing – without compromise. Truvian’s expanding portfolio of assays delivers central‑lab quality results available to anyone, anywhere. Learn more at truvianhealth.com or follow us on LinkedIn.
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Contacts
Media Contact:
Katherine Atkinson
katherine.c.atkinson@truvianhealth.com
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