MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers. In particular, Astute developed the NEPHROCHECK® test, an FDA-cleared test for the early risk assessment of acute kidney injuries (AKI) based on the level of two biomarkers, IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2).
This acquisition builds upon the fruitful partnership developed in 2015 between Astute Medical and bioMérieux when Astute granted bioMérieux a license to develop and market the NEPHROCHECK® test for the VIDAS® automated immunoassay system. Since 2017, bioMérieux has been a licensed distributor with Astute for the NEPHROCHECK® test on the Astute140 Meter in the US.
Astute Medical has developed a strong network of Key Opinion Leaders and demonstrated significant value for NEPHROCHECK® with peer-reviewed outcomes studies. bioMérieux intends to continue to invest in health economic and outcome studies for NEPHROCHECK®, explore the other promising biomarkers in the Astute pipeline as well as work with Astute’s current license and distribution partners in order to make the NEPHROCHECK® test available to as many patients as possible worldwide.
AKI is a major public health threat that is common, costly and potentially fatal in hospitalized patients1. Today, up to 50 percent of severely ill patients develop AKI2 which can result in prolonged hospital stays3, chronic kidney disease4, a greater risk of mortality3, and higher cost of care3. An outcomes study published recently by the journal Intensive Care Medicine5 reported a 33.9 percent reduction in the occurrence of moderate to severe AKI following cardiac surgery when clinicians used the NEPHROCHECK® test to identify patients with moderate to severe risk for AKI and then implemented a bundle of care recommended by the Kidney Disease Improving Global Outcomes (KDIGO) guidelines.
For the critically ill patient, unique biomarker tests such as the VIDAS® BRAHMS PCT™ and the NEPHROCHECK® test are complementary: procalcitonin guidance shortens antibiotic exposure, which can be important in preserving kidney health, while the NEPHROCHECK® test determines AKI risk, which is key for antibiotic management and other medical interventions.
“We are very enthusiastic to welcome the Astute team as part of bioMérieux after 3 years of beneficial collaboration,” commented Alexandre Mérieux, Chairman and Chief Executive Officer. “Because of its relevance in many severe medical conditions, the NEPHROCHECK® test developed by Astute perfectly fits bioMérieux’s strategy to differentiate VIDAS® through proprietary markers and to provide our customers with innovative and high medical value diagnostic solutions for improved patient care.”
Chris Hibberd, Astute Medical Chief Executive Officer, added: “Astute’s innovative Acute Kidney Injuries products offer a unique opportunity to address an important area of critical care in the hospital. bioMérieux’s global footprint, critical care presence and dedication to areas of high medical need positions the Company well to advance and scale this opportunity with the Astute team and its partners. The Astute team has enjoyed a wonderful collaboration with bioMérieux and we look forward to building this together.”
bioMérieux has agreed to acquire all shares of Astute Medical Inc. for approximately $90 million in cash. Due to investments for commercialization, and further health economic and outcome research, the estimated operating expenses related to Astute for the remaining 9 months of the year could drive an impact of -60 bps on the 2018 contributive operating income of bioMérieux.
The NEPHROCHECK® test is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are intensive care unit (ICU) patients as an aid in the risk assessment for moderate or severe AKI within 12 hours of patient assessment.
The NEPHROCHECK® test System is intended to be used in patients 21 years of age or older. NEPHROCHECK® received 510(k)-clearance through the FDA’s de novo classification and is CE-marked and available in Europe.
For more information on the NEPHROCHECK® test visit www.nephrocheck.com
A world leader in the field of in vitro diagnostics for more than 50 years, bioMérieux is present in more than 150 countries through 43 subsidiaries and a large network of distributors. In 2017, revenues reached €2,288 million, with over 90% of international sales.
bioMérieux provides diagnostic solutions (systems, reagents, software) 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
(1) Lewington AJP, 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) Dasta JF, Kane-Fill SL, Durtschi, AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23:1970-1974.
(4) Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2014;00:1-8
(5) Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomized controlled trial. Intensive Care Med. (2017). doi:10.1007/s00134-016-4670-3.