Nightingale Health Plc
Press release
7 February 2025 at 2:15 p.m. (EET)
Nightingale Health Plc ("Nightingale Health"), a pioneer in disease risk detection and preventative health announces its regulatory plan for the U.S. market. Nightingale Health announced last year that it will establish a laboratory in the U.S., and has now selected the State of New York as the location for the laboratory. This location provides significant benefits for the regulatory pathway for Nightingale Health's services as FDA premarket review is not required (as described below). FDA's latest rule on laboratory developed tests is the most significant clarification to the pertinent FDA regulation in decades, and puts Nightingale Health in a more favourable position to enter the U.S. market.
Nightingale Health expects to achieve regulatory readiness in the U.S. on an accelerated timeline
In 2024, FDA announced its new Quality Management System Regulation ("QMSR"), which will take effect February 2, 2026, and largely incorporates by reference the quality management system requirements of ISO 13485:2016 ("ISO 13485"). In light of this upcoming regulation and FDA's ruling on laboratory developed tests, Nightingale Health's investments to ISO 13485 certified quality management system, as well as experience from achieving regulatory approvals globally, provide the company confidence in being able to provide its services in the U.S. to healthcare customers on a rapid timeline.
Nightingale Health's technology is already adopted into nationwide healthcare use in Finland, and the company has excellent readiness to expand its services to routine use in other healthcare systems globally. When entering new markets, the regulatory landscape is one of the key factors to consider.
In the U.S., FDA regulates the sale of medical device products while laboratory testing of human samples for health assessment is generally regulated by CMS under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"). However, clinical laboratories located in New York are an exception, as they are required to maintain a clinical laboratory permit issued by the New York State Department of Health Clinical Laboratory Evaluation Program ("CLEP"). The CLEP permit requirements meet or exceed CLIA condition-level requirements and therefore laboratories located in and licensed by the State of New York with a CLEP permit are currently exempt from the CLIA requirements.
Nightingale Health's plan therefore is to first apply for a CLEP permit for its New York laboratory to begin offering services in the United States. The next step in the plan is to submit to FDA an application for premarket review by November 2027, which will be significantly supported by the CLEP approval, once obtained. Nightingale Health expects to be ready to launch its first service in the U.S. on an accelerated timeline. More specific timelines for the CLEP process will be updated later.
FDA premarket review not required before November 2027
FDA premarket review is generally required when introducing a medical device into commercial distribution in the U.S. However, Nightingale Health's regulatory plan is based on FDA's final rule titled "Medical Devices; Laboratory Developed Tests" (89 Fed. Reg. 37286-37445, published May 6, 2024 and effective July 5, 2024) (the "LDT Final Rule"), which clarifies rules for bringing in vitro diagnostic products offered as laboratory developed tests ("LDTs") to the U.S. market.
FDA has historically exercised enforcement discretion such that it generally has not enforced applicable legal requirements with respect to most LDTs. In the LDT Final Rule, FDA announced the establishment of a phased plan to gradually enforce the regulation of most in vitro diagnostic products offered as LDTs.
FDA premarket review requirements will be the last requirements for which compliance will be expected under the LDT Final Rule. In particular, compliance with FDA premarket review requirements will not be expected for high-risk IVDs offered as LDTs until November 6, 2027. FDA further describes that it applies this delayed implementation of premarket review requirements to IVDs that are manufactured and offered as LDTs by laboratories that meet CLIA requirements to perform high complexity testing, even if those IVDs do not fall within FDA's traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory. CMS has issued a currently effective exemption from CLIA requirements for laboratories located in New York State that hold valid CLEP permits. This exemption reflects that CLEP laboratory requirements are equal to or more stringent than those of CLIA; accordingly, CLEP-permitted laboratories can be understood to meet CLIA condition-level requirements.
This means that at least until November 6, 2027, FDA is expected to generally refrain from enforcing FDA premarket review requirements for Nightingale Health's test when offered in one or more laboratories with valid CLEP permits. If a premarket submission is received by FDA by said date, FDA will continue to exercise enforcement discretion with respect to the underlying test as long as the submission remains under review.
Even after November 2027, FDA premarket review will generally not be required for traditional LDTs approved by NYS CLEP
In the LDT Final Rule, FDA states that it "generally intends to exercise enforcement discretion with respect to premarket review requirements for LDTs that are approved by NYS CLEP." In other words, for any test that meets FDA's traditional LDT definition, CLEP approval will effectively create general enforcement discretion with respect to FDA premarket review requirements for the LDT even after the relevant FDA premarket review compliance date.
This means that also after November 6, 2027, provided that Nightingale Health has received CLEP approval, Nightingale Health may provide its test from a single laboratory, consistent with FDA's traditional LDT definition, even without submitting a marketing submission to FDA for premarket review.
U.S. QSR requirements to be largely replaced with ISO 13485
In addition to the requirements for FDA premarket review described above, another key FDA requirement is regulations requiring maintenance of a quality management system.
In January 2024, FDA announced the publication of its QMSR final rule, which when effective on February 2, 2026, will implement significant revisions to FDA's quality system requirements for medical devices. Specifically, the QMSR will largely replace FDA's existing quality system regulation (QSR) with ISO 13485. ISO 13485 is an international consensus standard for medical device quality management systems from the International Organization for Standardization.
Nightingale Health's quality management system, which will be implemented in the New York laboratory, has been compliant with ISO 13485 since 2017, and the FDA rule incorporating ISO 13485 in the U.S. makes the company's position significantly better as the company is already compliant with ISO 13485 and has experience with localising necessary documentation in different countries, such as Singapore.
Once Nightingale Health's New York laboratory is set up and the CLEP permit processes are underway, Nightingale Health will publish updates on the expected regulatory timeline.
For further information, please contact:
Teemu Suna, CEO
ir@nightingalehealth.com
About Nightingale Health
Nightingale Health's mission is to build sustainable healthcare and reduce health inequalities. Nightingale Health has developed the world's most advanced health check that provides risk detection for multiple chronic diseases from a single blood sample. Nightingale's Health Check can be scaled to entire populations at a low cost, and it can replace many of the current clinical risk assessments. Detecting disease risks on a population level allows for the effective targeting and tracking of health interventions, and better prevention of the onset of chronic diseases. With every sample we help to create a healthier world.
Nightingale Health operates globally with a parent company in Finland and seven subsidiaries in countries such as Japan, the United States, Singapore, and the United Kingdom. Nightingale Health has customers in more than 34 countries in the healthcare and medical research sectors. The company's technology is being used in many of the world's leading health initiatives, such as the UK Biobank, and over 600 peer-reviewed publications validate the technology. The company's Series B shares are listed on the First North Growth Market Finland marketplace. Read more: https://nightingalehealth.com/
