bioMérieux receives FDA Clearance for NEPHROCHECK® test on VIDAS®
August 4, 2022
Marcy l’Etoile, France – July 28 , 2022 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced the FDA Clearance of the innovative VIDAS® 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 patients and up to 50% of critically ill patients1-3. The condition is associated with a 10-fold increase in hospital mortality and a higher rate of chronic kidney disease among post-op patients4.
While a number of acute risk factors and patient characteristics have been identified which predispose patients to AKI, current diagnostic tools are inadequate for a clinician to establish a clear risk profile for any given patient5. 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 fashion.
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 can intervene sooner to either rule out kidney stress with confidence, or implement a series of protective measures for the kidneys.
“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, Chief Medical Officer, bioMérieux.
VIDAS® is an automated system that provides laboratory personnel with increased throughput and full traceability of test results. The addition of the innovative NEPHROCHECK® assay onto the VIDAS® platform is complementary to other tests that can be run concurrently to aid in the diagnosis of sepsis, which is a significant risk factor for AKI.
NEPHROCHECK® test kits are FDA cleared on both ASTUTE140® meter and VIDAS® instrument. VIDAS® NEPHROCHECK® will be available in the US in 2023.
“Considering the proportion of individuals affected each year, AKI represents a significant burden to patients, 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.
Since early 2021, VIDAS® NEPHROCHECK® is available in key European markets and in selected countries that recognize CE marking. The FDA clearance provides the opportunity to serve a key market of bioMérieuxꟷ US hospitals and reference laboratories will be able to run this innovative test on bioMérieux’s VIDAS® 3 system, which allows for higher throughput, automation and traceability.