Waltham, MA - Nova Biomedical announces the launch of the Nova Max Pro Creatinine/eGFR Meter System in all CE countries. Nova Max Pro is an important 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 easy-to-use 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.
Image credit: Nova Biomedical
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 crisis and is growing at an accelerated rate, 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, a very difficult end-stage treatment for the patient and a very expensive one for the healthcare system. 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 breakthrough 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 technology which has been used in point-of-care applications for over 15 years. Nova’s technology has been proven in clinical studies in numerous non-hospital settings, including pharmacies, community health centers, imaging centers, 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.1 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 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).2 The study validated that it is feasible to implement a comprehensive program 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.
About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacture of whole blood, point-of-care and critical care analyzers, as well as instruments for cell culture monitoring in the biotechnology market. Nova uses biosensor technology in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for stat measurement of over 22 analytes. Nova’s Bio Profile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests for a broad range of cell culture applications. Nova employs over 1,400 people worldwide and has wholly owned subsidiaries located in Benelux, Brazil, Canada, France, Germany, Great Britain, Italy, Japan, Spain, and Switzerland. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S. and Taiwan. www.novabiomedical.com
- Iker Camara-Ramos GE et al. The Importance of Community Pharmacy in Chronic Kidney Disease Patient Management. Drug Dosage Adjustment and Nephrotoxicity Detection. Poster-WONCA. 2021.
- Mehta R L et al. Recognition and management of community-acquired acute kidney injury in low-resource settings in the ISN 0by25 trial: A multi-country feasibility study. PloS Medicine. 2021;18:ee1003408
FDA clears Nova’s Stat Profile Prime Plus analyzer for micro capillary sample mode