Truvian Health accelerates FDA clearance plans with US $74M funding round

Truvian Health accelerates FDA clearance plans with US 74M funding round

USA – San Diego-based Truvian Health has taken a major step forward in revolutionizing blood diagnostics, securing US $74 million in funding.

The funding round was co-led by Great Point Ventures and Wittington Ventures, alongside existing backers such as Medical Excellence Capital, Tao Capital, and 7wireVentures, among others.

Truvian Health’s flagship product is a compact, automated benchtop system designed to provide lab-accurate blood test results within 30 minutes.

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Using just a small sample—approximately 300 microliters—the device performs a broad array of tests, including clinical chemistry, immunoassays, and hematology panels.

This covers key diagnostics such as lipid panels, hemoglobin A1c, comprehensive metabolic panels, and thyroid function tests (TSH).

By integrating traditionally separate diagnostic processes into a single platform, the system offers a convenient, cost-effective alternative to off-site laboratories.

Its application in clinics, provider offices, and pharmacies could fundamentally reshape healthcare delivery by enabling timely, informed decisions and reducing overall healthcare costs.

Clinical performance

Recent studies demonstrate Truvian’s platform reliability and accuracy. In a preprint study involving over 50,000 samples from approximately 5,000 donors, the device achieved a 98% reliability rate for generating successful test results.

Concordance testing against established instruments, including Roche’s Cobas devices, showed strong agreement with central laboratory data, bolstering confidence in the platform’s utility.

Chief Executive Officer Jay Srinivasan emphasized the transformative potential of the device:

We are on the cusp of delivering what the world needs to counter today’s non-communicable disease burden and unsustainable healthcare costs. These new investments and strategic partnerships further validate our goal to bring convenient, comprehensive testing to primary care, enabling patients and their doctors to make timely decisions affecting their health.”

Path to market

The recent funding will primarily support Truvian’s efforts to achieve FDA clearance, a critical milestone for the platform’s entry into the U.S. healthcare market.

The partnership with Shoppers Drug Mart is expected to drive commercial adoption in Canada, demonstrating the scalability of Truvian’s innovation.

Truvian joins a growing cohort of companies aiming to decentralize diagnostics and enhance accessibility.

Competitors like Everlywell, LetsGetChecked, and CVS Health offer at-home test kits for various health metrics, while Truvian focuses on delivering central-lab-quality results directly in point-of-care settings.

By consolidating over 90% of routine blood tests into a single device, Truvian is positioned to streamline chronic disease management and enhance patient engagement.

Immediate, accurate results empower patients and providers to address health concerns in real time, potentially improving outcomes and reducing the economic burden of chronic illnesses.