For a new clinical laboratory in New York State, the CLEP process has two stages. First, the laboratory itself must hold a clinical laboratory permit. Second, the laboratory submits each laboratory developed test, meaning individual blood values in the Nightingale Health Check, to CLEP with the validation data for that test, and CLEP approves each test separately. The approvals now received are the first for Nightingale Health’s tests in this second stage. Nightingale Health continues to submit its remaining laboratory developed tests for review under CLEP procedures.

Following a U.S. District Court ruling in 2025, laboratory developed tests remain regulated mainly under the CLIA/CLEP framework, the federal and New York State rules for clinical laboratories, rather than by the U.S. Food and Drug Administration (FDA). They do not require a separate FDA approval. For Nightingale Health, whose U.S. laboratory is in New York, test approvals under CLEP are therefore the regulatory route for its tests in the United States, the world’s largest healthcare market.

“For a new measurement technology, the first test approvals are the most important ones. That is the first time that tests based on the measurement are reviewed against the validation requirements, and New York State has now approved the first tests based on our measurement technology. Every further test is submitted with its own validation data for CLEP’s review, and our goal is unchanged: to make our technology available to healthcare in the United States,” says Teemu Suna, CEO and Founder of Nightingale Health.

The Nightingale Health Check is approved for healthcare use in the European Economic Area, the United Kingdom, Japan, and Singapore. In the United States, Nightingale Health’s tests are provided as laboratory developed tests from the company’s own laboratory in New York.