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Development of New Test to Improve Early Detection of Chronic Kidney Disease

MedTech device, ACT by Zensorium, developed by Nitto Denko Asia Technical Centre (NAT) is an early chronic kidney detection test without the need for refrigeration in the testing process, improving ease of testing and ultimately, patient access.

Chronic Kidney Disease is the sixth most common cause of death in Singapore, yet only 10 percent of those with Chronic Kidney Disease know they have it. NAT aims for a Singapore rollout, across polyclinics and general practitioner clinics to be followed by regional country expansions, following good results of its testing phase with SGH.

“No laboratory-grade chronic kidney tests can be done in the rural areas in the tropical climates of Southeast Asia without investing in facility infrastructure. We removed the need for cold-chain processes in our chemicals and engineered our device to achieve consumer-grade kidney tests that will cut down costs, and improve access even in a primary care setting,” said Dr Visit Thaveeprungsriporn, Managing Director of Nitto Denko Asia Technical Centre, the R&D centre of Nitto Denko focused on MedTech.

End-stage kidney disease is the sixth most common cause of death in Singapore. Each day an average of five new patients are diagnosed and this is likely to rise further with Singapore’s increased prevalence of diabetes and ageing population. Support and funding for innovation and research are key to improve early detection, treatment and management.

ACT by Zensorium works by testing urine for an increased level of albumin (a protein) and creatinine which correlates with a higher risk of Chronic Kidney Disease onset and progression, especially in patients with Diabetes Mellitus and Hypertension. Zensorium is NAT’s MedTech device brand.

To combat the region’s Chronic Kidney Disease epidemic, preventive intervention is the key to avert the irreversible progression of kidney disease. Screening facilities are only available in major cities, requiring many patients in Southeast Asia’s rural areas to travel long distances to seek care. Faced with these hurdles, many patients may never come to medical attention.

Basic Chronic Kidney Disease screening options today use test strips which can give you a rough estimate of how the kidney is functioning. The results of these screenings are often qualitative instead of quantitative, and thus difficult for early detection of kidney problems. In comparison, ACT by Zensorium has a specificity and sensitivity of over 95% compared to laboratory-grade kidney tests. This is possible because the testing device and test cartridges are designed to prioritise ease of use but still be highly robust to minimises errors from handling and measurement by testing personnel.

ACT by Zensorium uses a proprietary solution to ensure that costly cold-chain refrigeration processes are not needed when storing and transporting the cartridge packed with test reagents, offering a competitive cost at point-of-care sites. The system is now being tested at SGH as a part of the clinical verification and product finalisation process.

“We created ACT by Zensorium in Singapore but that’s just the start – our device could change the game for early kidney disease intervention region-wide,” added Dr Visit Thaveep.

Following this phase, NAT plans to apply for product registration and approval from Singapore’s Health Sciences Authority for the device’s rollout. The team will identify partners to collaborate with on a nationwide polyclinic rollout and they intend to expand to other countries in Southeast Asia. [APBN]