DEERFIELD, Ill. & MARCY L’ETOILE, France – (COMMERCIAL THREAD) – Baxter International Inc. (NYSE: BAX), a world leader in acute care, and bioMérieux (EPA: BIM), a world leader in in vitro diagnostics, today announced the CE marking of the NEPHROCLAIR™ CCL14 Test. The NEPHROCLAIR™ CCL14 The test is designed to predict severe persistent acute renal failure (PS-AKI) and can be used to support clinical decision making and timely care pathways. The companies intend to commercially launch the NEPHROCLAIR™ CCL14 Test in Western Europe in 2022.
“Baxter is proud to partner with bioMérieux to offer the NEPHROCLAIR™ CCL14 The test is an important new diagnostic option to support the individualized management of ARI that provides each patient with the best opportunity for recovery, ”said Reaz Rasul, CEO of Baxter’s Acute Therapies business. “We remain committed to advancing targeted innovation across the continuum of care to help reduce complexity and enable efficiency in critical care, especially as hospitals continue to feel the impact of the COVID-pandemic. 19. ”
“This new step in our collaboration with Baxter further strengthens our portfolio of innovative diagnostic solutions for the management of ARI, ”said Pierre Boulud, Director of Operations, Clinical Operations, bioMérieux. “True to our public health mission, we bring to the medical community this high medical value immunoassay that has the potential to change the current strategy of care for patients with ARI.
AKI is a sudden decrease in kidney function over a period of hours to days, often as a result of illness, trauma, or infection. The sudden loss of kidney function leads to a buildup of toxins and fluid in the blood which, if left untreated, can lead to death. Baxter recently collaborated with bioMérieux and Premier Applied Sciences® (PAS) to conduct a study evaluating the economic and clinical impact of PS-AKI. Data from this study presented at the International Symposium on Critical Care and Emergency Medicine (ISICEM) showed that PS-AKI (stage 3 AKI lasting ≥ 3 days) is independently associated with longer length of stay and higher costs during index hospitalization and 30-day follow-up compared to ‘Non-persistent ARI. Additional data from this study, presented at the LIVES Congress of the European Society of Intensive Care Medicine (ESICM), showed that PS-AKI is prevalent in adults hospitalized in the United States and is associated with a significantly higher risk deaths during hospitalization, as well as readmissions, dialysis and death during the 30-day follow-up, compared to patients without PS-AKI.
A Acute Disease Quality Initiative consensus conference statement highlights the importance of new biomarkers like CCL14 (CC motif chemokine ligand 14), the biomarker measured by the NEPHROCLAIR™ CCL14 Testing, to help manage ARI by identifying high-risk patient groups, guiding therapy, and improving care pathways.1 Recent studies published in Intensive care medicine,2 Critical care3 and Journal of Thoracic and Cardiovascular Surgery4 suggest that CCL14 is the most predictive biomarker of PS-AKI compared to other AKI biomarkers including NGAL, CHI3L1, L-FABP, Cystatin C, Proenkephalin and KIM-1.
The NEPHROCLAIR™ CCL14 The test provides a reliable and accurate measurement to help clinicians assess an individual patient’s risk of developing PS-AKI. The area of the test under the Receptor Operating Characteristic Curve (AUC), which is an indicator of the overall accuracy of a diagnostic test, is 0.82, illustrating the ability of the CCL14 biomarker to distinguish patients susceptible to develop a PS-AKI of those who will not.2, 5 Test results can help clinicians determine personalized treatment approaches for each patient, including level of care and the need for appropriate interventions, based on Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines.3, 5, 6 When test results show that a patient is at increased risk for PS-AKI, they may be tutored to a higher level of care to help alleviate potential complications of AKI.2, 3
Baxter and bioMérieux previously announced an agreement to develop and distribute this new AKI biomarker assay to assess the risk of PS-AKI and support clinical decision making in the management of AKI. Both companies will provide assistance at the customer’s site for the NEPHROCLAIR™ CCL14 Testing, while bioMérieux retains control of the regulatory approval process and Baxter retains control of the marketing strategy. Baxter is the exclusive distributor of bioMérieux of NEPHROCLAIR™ CCL14 Testing in Europe and will also be the exclusive distributor in the United States pending approval from the United States Food and Drug Administration (FDA).
Intended Use of CE Marking / Important Safety Information for NEPHROCLEAR™ CCL14 test
The NEPHROCLAIR™ CCL14 The test is an automated immunofluorescence test for use on the ASTUTE140® Measuring apparatus for the quantitative measurement of CCL14 (CC chemokine motif ligand 14) in human urine.
The NEPHROCLAIR™ CCL14 The test is intended to be used in conjunction with clinical evaluation in adult patients hospitalized with acute disease or condition and with moderate or severe acute renal failure (AKI) (stage 2 or 3) to aid in the assessment. risk of developing persistent severe ARI (stage 3 lasting ≥ 72 hours) within 48 hours of patient assessment.
Rx only. For safe and proper use of the products mentioned in this document, please refer to the Operator’s Manual or the Instructions for Use.
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, nephrology, hospital and surgical products. For 90 years, we’ve operated at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make them happen. With products, technologies and therapies available in more than 100 countries, Baxter employees around the world are now building on the company’s rich heritage of medical breakthroughs to advance the next generation of transformative innovations. in health care. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
A world leader in the field of in vitro diagnostics for more than 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2020, turnover reached 3.1 billion euros, with more than 90% of international sales (excluding France).
bioMérieux provides diagnostic solutions (systems, reagents, software and services) that determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for the diagnosis of infectious diseases. They are also used for the detection of microorganisms in food, pharmaceutical and cosmetic products.
This press release includes forward-looking statements regarding the NEPHROCLAIR™ CCL14 Testing, including the potential benefits associated with the product. Statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those of forward-looking statements: market demand and acceptance for new and existing products; risks associated with product development; the inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of natural disasters, public health crises and epidemics / pandemics, regulatory or other); meeting regulatory and other requirements; actions of regulatory agencies and other government authorities (including the potential FDA clearance of the NEPHROCLAIR™ CCL14 Test); product quality, manufacturing or supply or patient safety issues; changes in law and regulations; and other risks identified in Baxter’s latest filing on Form 10-K and other SEC filings, all available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.
Baxter is a registered trademark of Baxter International Inc. BIOMÉRIEUX, the BIOMÉRIEUX logo, ASTUTE140 and NEPHROCLEAR are registered or pending trademarks owned by bioMérieux or one of its subsidiaries.
1 Ostermann M, Zarbock A, Goldstein S, et al. Acute Kidney Injury Biomarker Recommendations from the Acute Disease Quality Initiative consensus conference: a consensus statement. JAMA Netw Open. 2020; 3 (10): e2019209. doi: 10.1001 / jamanetworkopen.2020.19209
2 Hoste E, Bihorac A, Al-Khafaji, A, et al. Identification and validation of biomarkers of persistent acute renal failure: the RUBY study. Intensive Care Med 46, 943-953 (2020). https://doi.org/10.1007/s00134-019-05919-0
3 Bagshaw, SM, Al-Khafaji, A., Artigas, A. et al. External validation of urinary C – C motif chemokine ligand 14 (CCL14) for the prediction of acute persistent renal failure. Crit Care 25, 185 (2021). https://doi.org/10.1186/s13054-021-03618-1
4 Massoth C, et al. Comparison of the CC chemokine ligand 14 motif with other biomarkers for adverse renal events after cardiac surgery. J Thorac Cardiovascular Surg. March 10, 2021: S0022-5223 (21) 00436-0. doi: 10.1016 / j.jtcvs.2021.03.016
5 Package leaflet for the BioMérieux NephroClear CCL14 test kit
6 International Society of Nephrology. (2012) KDIGO Clinical Practice Guidelines for Acute Kidney Injury. Kidney Int. Suppl. 2, 1-138. https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-AKI-Guideline-English.pdf