Nova Biomedical launches CE-marked Nova Max Pro Creatinine/eGFR meter for kidney function screening

Nova Biomedical has launched the Nova Max Pro Creatinine/eGFR Meter System in all CE countries. Nova Max Pro is a new tool to improve kidney care through kidney function screening and early detection of kidney disease in point-of-care settings outside the hospital. 

The Nova Max Pro meter and creatinine biosensor measure blood creatinine and calculate estimated glomerular filtration rate (eGFR), two important indicators of overall kidney function, from a tiny 1.2 microliter capillary fingerstick blood sample in just 30 seconds.

The Nova Max Pro measurement technique is virtually identical to the use of a glucose meter by people with diabetes. Creatinine and estimated glomerular filtration rate (eGFR) results are reported using the CKD-EPI equation (with or without race as a factor) from a small, fingerstick blood sample that eliminates the need for venous blood sampling. Patient creatinine and eGFR test results are displayed in seconds and can be stored on the meter or wirelessly communicated to Bluetooth enabled applications for review and intervention by healthcare professionals.

Chronic kidney disease (CKD) is a major healthcare issue with increasing prevalence, rising from 13th to 10th place in the World Health Organization ranking of most common causes of death. Kidney disease is often termed the “silent killer” because it shows no symptoms and is often diagnosed at a late stage when there are few treatment options other than dialysis. If detected early, kidney disease progression can be prevented or delayed. 

According to Doug Curley, Nova Sales Product Manager: “Today the availability of new drugs to retard the progression of kidney disease makes it even more important to detect kidney disease early so treatment can be started before it is too late. Nova Max Pro is a very rapid, accurate break-
through that improves kidney care by bringing screening and early detection of kidney disease to locations outside the hospital, such as pharmacies, clinics, and physician offices.”

Nova Max Pro Creatinine measuring technology is based on the Nova StatSensor Creatinine techno-logy which has been used in point-of-care applications for more than 15 years. Nova’s technology has been proven in clinical studies in numerous non-hospital settings, including pharmacies, community health centres, imaging centres, clinics, physician offices, and home testing by individuals. 

One pharmacy study in Spain used Nova creatinine/eGFR measuring technology to screen patients who were asymptomatic for CKD but were either on potentially nephrotoxic medications or at risk for chronic kidney disease. A remarkable 44% of the patients tested had an eGFR <60 (the level indicating kidney disease), highlighting the value of kidney disease screening in the pharmacy outpatient setting. 

Another large university study < https://doi.org/10.1371/journal.pmed.1003408 > sponsored by the International Society of Nephrology examined the feasibility of community screening of at-risk individuals in three rural, low-middle-income countries (LMIC). The study validated that it is feasible to implement a comprehensive programme utilizing POC testing and protocol-based management to improve the recognition of kidney disease in high-risk patients in these rural settings. Nova Max Creatinine/eGFR is also being used in an ongoing study that spans 25 countries and is focused on screening of asymptomatic but potentially at-risk patients in clinics and physician offices for kidney disease. The thesis for this study is that early detection will improve outcomes for patients by allowing early treatment.