Inside information: Nightingale Health achieves major milestone in the United States: New York laboratory now holds a clinical laboratory permit from New York State

Nightingale Health, (Nasdaq Helsinki: HEALTH; OTCQX: NHLTY, NGHLF), a pioneer in disease risk detection and preventive health, has today been granted a clinical laboratory permit by the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) for the company’s laboratory in New York. Laboratories located in New York State are required to hold a New York State clinical laboratory permit, and testing for healthcare customers in the United States may commence only once a permit has been issued.

Receiving the permit marks a major milestone in Nightingale Health’s U.S. operations. Achieving permit approval demonstrates the company’s ability to meet stringent U.S. regulatory requirements and strengthens its entry into the world’s largest healthcare market.

Following recent U.S. District Court ruling in 2025, laboratory developed tests (“LDTs”) remain regulated mainly under the CLIA/CLEP framework rather than by the U.S. Food and Drug Administration (FDA). Nightingale Health is therefore in a good position on its regulatory roadmap after receiving the CLEP permit, since LDTs do not require a separate FDA approval.

The CLEP permitting process evaluates laboratory’s reliability and operational quality through an on‑site inspection that reviews facilities, equipment, personnel qualifications, record‑keeping practices and compliance with quality management requirements. Nightingale Health successfully completed this evaluation for its New York laboratory, confirming compliance with the requirements set out by the New York State Department of Health.

For new clinical laboratories in the New York State, the CLEP process includes laboratory approval and separate test approvals for each testing category. With the laboratory permit now issued, Nightingale Health will begin submitting its laboratory developed tests for review and approval under CLEP procedures.

Teemu Suna, CEO and Founder, stated: “Obtaining the CLEP permit in New York is a significant milestone in our U.S. expansion. This achievement confirms that our New York laboratory complies with the state’s rigorous regulatory standards and gives us a solid basis to add our tests under the permit. We are excited about bringing our innovative disease-risk detection to U.S. healthcare.”