bioMérieux Announces the CE Marking of NEPHROCHECK® Test on VIDAS®
MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced the CE marking of the innovative NEPHROCHECK® assay to detect kidney stress in patients at risk of acute kidney injury (AKI).
AKI is a common complication, affecting between 7 and 18% of all hospitalized patients1 and up to 50% of critically ill patients2. The condition is associated with a 10-fold increase in hospital mortality and a higher rate of chronic kidney disease among post-op patients3.
While a number of acute risk factors and patient characteristics have been identified which predispose patients to AKI4, there is no reliable way for a clinician to establish a clear risk profile for any given patient. Delays in recognizing AKI can potentially lead to irreversible consequences. In many cases, adverse patient outcomes are avoidable if the condition is identified and managed in a timely fashion5.
NEPHROCHECK® is an innovative test that detects kidney stress prior to actual damage, when a timely intervention can still make a difference. It is intended to be used in conjunction with clinical evaluation as an aid to support the risk assessment of moderate or severe AKI in acutely ill patients. With this early information, clinicians may either rule out kidney stress with confidence, or implement a series of protective measures for the kidneys.
The NEPHROCHECK® test relies on the detection of 2 innovative urinary biomarkers: TIMP-2 (tissue inhibitor of metalloproteinases-2) and IGFBP-7 (insulin-like growth factor-binding protein 7). Both proteins are produced by stressed kidney cells as an early warning signal, before the onset of AKI. Specific to kidney stress, they are not affected by any of the usual co-morbidities (such as sepsis, trauma, chronic kidney disease or cancer).
“As a predictive tool for AKI, NEPHROCHECK ® provides clinicians with high medical-value information and can lead to benefits in patient care and improved outcomes. The development of this test is consistent with our focus on improving care for individuals with acute medical and critical conditions. It complements our existing pioneering assays for these patients, such as procalcitonin (PCT),” said Mark Miller, Executive Vice President and Chief Medical Officer, bioMérieux.
“Considering the proportion of patients affected each year, AKI represents a significant burden on the functioning of intensive care units and has a huge economic impact on healthcare systems. Innovative assays like NEPHROCHECK® not only contribute to improved patient outcomes but could potentially help optimize hospital costs,” said Pierre Boulud, Chief Operating Officer, Clinical Operations of bioMérieux.
Effective immediately, VIDAS® NEPHROCHECK® is available in key European markets and will gradually be deployed in countries that recognize CE marking. Hospitals and private laboratories will be able to run the tests on bioMérieux’s VIDAS® 3 system, which allows for higher throughput, automation and traceability. bioMérieux is planning a submission for FDA clearance in the near future.
Launched 30 years ago, VIDAS® has transformed the field of immunoassays offering laboratories universal access to a simple, automated and robust technology providing fast and safe results. Today, VIDAS® is still the most widely used immunoassay system in clinical laboratories worldwide.
The VIDAS® menu comprises over 100 parameters, covering a wide range of pathologies, including infectious diseases and chronic diseases, as well as a range of tests dedicated to emergency and critical care. A number of these parameters are part of the bioMérieux full solution to address the global challenges of antimicrobial resistance (AMR) and sepsis. As it enters into its fourth decade, VIDAS® remains a major focus of the bioMérieux immunoassay strategy with ongoing research into new parameters and frequent launches that create value for labs and clinicians, ultimately bringing benefits for patients.
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2019, revenues reached €2.7 billion, with over 90% of international sales.
bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris stock market.
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP
Corporate website: www.biomerieux.com.
1. Lewington AJ, Cerdá J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3):457-467.
2. Mandelbaum T, Scott DJ, Lee J, et al. Outcome of critically ill patients with acute kidney injury using the AKIN criteria. Crit Care Med. 2011;39(12):2659-2664.
3. Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8.
4. Ronco C, Ricci Z. The concept of risk and the value of novel markers of acute kidney injury. Crit Care. 2013;17:117-118.
5. Mehta RL, Cerda J, Burdmann EA, et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015.
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