Nightingale Health Plc
Press release
August 20, 2024 at 9:15 a.m. (EST)
Nightingale Health Plc (“Nightingale Health”), a pioneer in disease risk detection and preventive healthcare, has received additional regulatory approvals from Singapore’s Health Sciences Authority (HSA), the national regulator for medical devices, therapeutics and other healthcare products.
Nightingale Health announced the first regulatory approval earlier this year, covering analysis of eight commonly used clinically biomarkers: total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, glucose and creatinine. The second regulatory approval covers analysis of fatty acids: total fatty acids, polyunsaturated fatty acids, monounsaturated fatty acids, saturated fatty acids, omega-3 fatty acids and omega-6 fatty acids.
Since late 2023, Nightingale Health has been working with Innoquest Diagnostics, a leading clinical diagnostic services provider in Singapore, to provide access to Nightingale Health’s blood analysis technology in Southeast Asia. This regulatory approval is an important step in the rollout of Nightingale Health’s comprehensive and high-quality blood testing services in the region.
Approval is based on verification of conformity to the safety and performance requirements for medical devices. HSA approval means that Nightingale Health’s product meets strict requirements for quality, safety and efficacy.
The ability to meet some of the world’s most stringent healthcare regulatory requirements demonstrates the applicability of Nightingale Health’s technology in routine blood testing, as it matches the quality of gold standard tests.
Furthermore, unlike current solutions, Nightingale Health’s technology improves on standard blood testing by providing a comprehensive panel of known gold standard biomarkers and, importantly, market-leading risk assessments for multiple chronic diseases from each sample measured. This capability enables the building of more preventative and sustainable healthcare systems worldwide.
“Nightingale Health’s blood analysis technology once again proves its potential to become the new, improved standard for routine blood testing in chronic diseases. By replacing current clinical chemistry methods, Nightingale Health’s blood test can provide groundbreaking value in building more preventative and sustainable healthcare,” says Teemu Suna, CEO and founder of Nightingale Health.
“Our technology not only directly replaces many of the usual blood tests, but also offers the first in the diagnostics industry to comprehensively determine the risk of developing chronic diseases. These capabilities are made possible by the unique combination of Nightingale Health’s proprietary blood analysis technology and the groundbreaking population-based approach,” Suna continues.
“Nightingale Health’s technology is already used in primary healthcare across Finland, covering approximately 30% of the Finnish working population. In addition to Singapore, we are also making rapid progress in introducing our technology into healthcare settings in the US and the UK. We are very excited to bring the benefits of modern blood testing technology to the world, and the additional regulatory approval in Singapore further demonstrates the high quality and performance of our unique technology,” Suna concluded.
For further information please contact:
Teemu Suna, CEO
[email protected]
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 detects the risk of multiple chronic diseases from a single blood sample. Nightingale’s health check can be scaled cost-effectively to entire populations and can replace many of the current clinical risk assessments. Identifying disease risk at the population level enables effective targeting and tracking of health interventions and better prevention of chronic disease outbreaks. With every sample, we help create a healthier world.
Nightingale Health operates globally and has a parent company in Finland and seven subsidiaries in countries such as Japan, the US, Singapore and the UK. Nightingale Health has customers in more than 34 countries in the healthcare and medical research sectors. The company’s technology is used in many of the world’s leading healthcare 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 market. More information: https://nightingalehealth.com
Keywords:
