Nephron Dx to develop more accurate diagnostic kit for early detection of diabetic CKD

Oct 18 2011

A new spin-off company from the National University of Singapore (NUS), called Nephron Dx, has recently been set up to develop a more accurate diagnostic kit for the earlier detection of diabetic chronic kidney disease. Nephron Dx aims to enter the multi-billion dollar kidney disease diagnostic market by 2013.

Chronic kidney disease is a major public health concern worldwide, especially among Type 2 diabetics. Current tests can only diagnose diabetic chronic kidney disease when protein is detected in the urine; a condition known as albuminuria. However, published studies have revealed that more than 10% of patients who tested negative for albuminuria may already have reduced kidney filtration capacity, resulting in chronic kidney disease. Nephron Dx will help clinicians detect such patients, allowing them to benefit from early therapeutic intervention, to lower their risk of renal or cardiovascular disease.

Nephron Dx's diagnostic platform works by detecting the presence of nephrin in the patient's urine sample. Nephrin is a critical protein found on specialised cells, called podocytes, in the kidney and is necessary for the kidney's filtration barrier to function properly. The presence of nephrin in the urine means that the kidneys have sustained some damage, and their blood filtering process may have already been compromised. Nephron Dx's diagnostic platform compares well to existing urine test kits currently on the market, which detect the presence of albumin. Albumin levels in urine are affected by various factors not necessarily linked to kidney disease, and its absence in urine may not necessarily mean the patient is free of kidney disease. See Annex A for more information on tests for kidney function.

"With risk factors for chronic kidney disease, such as diabetes, hypertension and obesity, on the rise, we saw the need for better and more accurate kidney disease diagnostic platforms. We believe that our platform will be particularly useful for detecting early stage kidney disease, as nephrin is intimately involved in normal kidney function. Nephron Dx plans to develop both disposable dipsticks for patients, as well as quantitative equipment for nephrologists," said Dr Daniel Ng, Assistant Professor at the new NUS Saw Swee Hock School of Public Health. Dr Ng was the principal investigator of this research at NUS, and is also a co-founder and scientific director of Nephron Dx.

To explore the role of nephrin in human kidney disease, Dr Ng and his NUS research team collaborated with Professor Harry Holthöfer from the University of Helsinki, to conduct a study on 381 Type 2 diabetes patients in Singapore. Patients' urine samples were tested for the presence of both nephrin and albumin. Blood samples also revealed patients' estimated glomerular filtration rates (eGFR), which serves to indicate how well the kidney is functioning. The results showed that the presence of nephrin in urine was strongly associated with reduced kidney function, measured by eGFR. More importantly, this was found to be true even for patients with normal urine albumin excretion levels, who would have traditionally been regarded as having low risk of kidney disease.

NUS Industry Liaison Office has filed a PCT patent application for this method of detecting reduced renal function. Nephron Dx has executed an option to license this technology exclusively from NUS. The company plans to commercialise the technology into a rapid and sensitive diagnostic kit for the early detection of kidney disease, as well as to predict renal disease progression.

"With Singapore's high rate of diabetes, it is heartening to see this NUS technology for detecting kidney disease being developed into a product that could potentially help to save millions of lives - not only in Singapore, but around the world," said Ms Irene Cheong, Director of NUS Industry Liaison Office, which is a division of NUS Enterprise.

"The nephrology community is always seeking novel bio-markers that can improve risk stratification of progression or severity of chronic kidney disease. Nephrinuria may be one such marker that I hope will make a difference in our management of patients with chronic kidney disease. Nephrinuria may improve early diagnosis as well as serve as prognostic marker for chronic kidney disease," said Dr Titus Lau, Senior Consultant at the Department of Medicine, National University Hospital.

Nephron Dx is being incubated by the Biofactory and also benefits from the NUS Enterprise incubation ecosystem. Moving forward, Nephron Dx is planning to raise funds, which will be used to create the diagnostic kits, conduct more trials, market the products and grow the team.