Nightingale Health (Nasdaq Helsinki: HEALTH | OTCQX: NHLTY), a Finnish leader in predictive health analytics, is on track to launch its U.S. laboratory operations in New York by Summer 2025, beginning with medical research clients before expanding to healthcare providers. The company’s strategic move into the Alexandria Center® for Life Science in Long Island City positions it to serve leading academic and clinical partners while leveraging proximity to major transportation hubs for efficient sample logistics.
The newly announced laboratory, situated in a hub for biotech innovation, provides direct access to collaborators like Weill Cornell Medicine’s Englander Institute for Precision Medicine, with which Nightingale has an existing partnership to integrate its blood analysis technology into precision medicine research. The site’s connectivity to airports, highways, and public transit ensures streamlined operations for domestic and international sample processing.
Nightingale is advancing its U.S. regulatory strategy by prioritizing a New York State CLEP permit, which exempts the lab from federal CLIA requirements due to its stringent standards. This approach allows the company to bypass immediate FDA premarket review under recent regulatory updates for laboratory-developed tests (LDTs), deferring compliance until November 2027. The phased plan aligns with FDA’s 2024 LDT Final Rule, which delays enforcement of premarket reviews for high-complexity tests.
Nightingale’s proprietary nuclear magnetic resonance (NMR) spectroscopy analyzes blood samples to generate 250 times more metabolic data than conventional tests, enabling multi-disease risk prediction from a single draw. This capability, already deployed in population-scale projects like the UK Biobank, supports Nightingale’s mission to shift healthcare toward prevention by identifying chronic disease risks earlier.
CEO Teemu Suna emphasized the laboratory’s role in meeting growing U.S. demand: “Our medical research clients have driven initial demand, but healthcare providers are increasingly seeking tools to personalize preventive care. This facility accelerates our ability to serve both sectors.” The lab’s scalable design accommodates future expansion as the company targets partnerships with hospitals and screening programs.
With subsidiaries in eight countries and clients across 34 markets, Nightingale has established its blood-testing technology as a research staple, validated by over 600 peer-reviewed studies. Its U.S. expansion builds on existing commercial efforts, including a production-phase partnership with Boston Heart Diagnostics to offer Health Check services domestically.
The company’s emphasis on preventive care aligns with global trends toward value-based healthcare, offering a cost-effective alternative to fragmented diagnostic workflows. By consolidating risk assessments for conditions like cardiovascular disease and diabetes into one test, Nightingale aims to reduce health disparities and improve intervention targeting.
Nightingale’s U.S. laboratory represents a critical step in scaling its health-check platform, which combines advanced analytics with population-wide applicability. As regulatory clarity solidifies, the company is positioned to capitalize on a $50 billion LDT market while advancing partnerships in precision medicine.
