Analyst Comment

A step forward for Nightingale in New York

Summary

Nightingale Health has received a Clinical Laboratory Evaluation Program (CLEP) permit from the New York State Department of Health, enabling it to offer testing to healthcare customers in the US.
The permit clarifies Nightingale's regulatory position in the US, as laboratory-developed tests (LDTs) will remain under the CLIA/CLEP framework without requiring FDA approval.
While the certification is a significant milestone, it does not lead to an immediate large-scale commercial ramp-up, as further test-specific approvals are needed.
The US market is strategically important for Nightingale, and the company has prepared for entry through partnerships and investments, maintaining a strong net cash position of 51 MEUR at the end of H1'25.

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Translation: Original published in Finnish on 02/10/2026 at 07:38 am EET

On Monday, Nightingale Health announced it had received a Clinical Laboratory Evaluation Program (CLEP) permit from the New York State Department of Health for the company's New York laboratory. The permit is a prerequisite for the company to begin offering testing to healthcare customers in the US. The news is a step forward in the company's US expansion strategy, but it does not cause immediate changes to our estimates.

A clinical permit for the New York laboratory

Nightingale Health has announced that it has received a clinical laboratory permit from the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP). The permit required a successful assessment of the laboratory’s facilities, equipment, personnel qualifications, and quality management systems. Without a CLEP permit, offering laboratory tests to healthcare customers is not possible in the State of New York.

Regulatory pathway for LDT tests clarifies

The news is positive for Nightingale as it clarifies the company's regulatory position in the US. Following a court ruling in 2025, laboratory-developed tests (LDTs) will largely remain under the CLIA/CLEP regulatory framework and will not require separate FDA approval. Obtaining the CLEP permit demonstrates the company's ability to meet demanding regulatory requirements and supports its goals in the world's largest healthcare market.

Progress in a strategically important market

While laboratory certification is a significant achievement, it does not yet mean immediate large-scale commercial ramp-up. Next, Nightingale will begin submitting its LDT tests for evaluation and approval under the CLEP procedure, which includes separate test-specific approvals for each testing category.

The US is a strategically important market for Nightingale, and the company has already prepared for market entry, for example, through its Boston Heart partnership. One-off investments in the New York laboratory have previously burdened the company's cash flow, but the net cash position has remained strong (51 MEUR at the end of H1'25). This is in line with the company's strategy, which aims to integrate into existing healthcare value chains. The release does not cause changes to our estimates, as we have already factored in the gradual opening of the US market into our long-term growth expectations.

Nightingale Health operates in the medical technology sector. The company specializes in the development of medical technology products. The product portfolio is broad and includes platforms and services within blood analysis that are used for disease prevention purposes. In addition to the main business, service and related ancillary services are also offered. The business is operated globally with the largest presence in Europe.

Key Estimate Figures19.09.2025

	2025	26e	27e
Revenue	4.7	7.9	8.8
growth-%	7.7 %	67.2 %	12.1 %
EBIT (adj.)	-19.4	-17.3	-15.2
EBIT-% (adj.)	-413.7 %	-220.4 %	-172.8 %
EPS (adj.)	-0.30	-0.27	-0.24
Dividend	0.00	0.00	0.00
Dividend %
P/E (adj.)	neg.	neg.	neg.
EV/EBITDA	neg.	neg.	neg.