Astute Medical And Ortho-Clinical Diagnostics Enter Strategic Collaboration To Advance Innovative Acute Kidney Injury Test

Collaboration to Expand Sales Breadth and Market Access

Jul 28, 2014, 08:00 ET from Astute Medical, Inc.

SAN DIEGO, July 28, 2014 /PRNewswire/ -- Astute Medical, Inc. today announced a strategic collaboration with Ortho-Clinical Diagnostics, Inc. (OCD) that will expand access to a new test that assesses critically ill patients for risk of acute kidney injury (AKI), a prevalent and deadly condition.  

A study recently published in the Journal of the American Society of Nephrology suggested that AKI could be more deadly than heart attack.1 However, in contrast to conditions such as heart attack, patients at risk for AKI do not show obvious clinical symptoms, particularly in the early stages when intervention is most beneficial.

Under the terms of the multi-year agreement, Astute Medical has designated OCD as the exclusive sales agent for Astute's NephroCheck® Test and Astute140® Meter in certain countries of the European Union and, if approved, in the United States. The NephroCheck® Test and the Astute140® Meter are currently not available for sale in the United States. Astute Medical is pursuing regulatory clearance to market the NephroCheck® Test and the Astute140® Meter in the United States.

Astute has also granted OCD a semi-exclusive worldwide license to develop and commercialize a version of the NephroCheck® Test for use on its VITROS® line of automated, high-volume testing platforms.  The test developed for the OCD platform will require separate regulatory clearances before it can be sold.

As a part of the strategic collaboration, OCD has made a $15 million equity investment in Astute Medical. The companies did not disclose further financial details of the agreement.

"We believe there is a tremendous unmet need for improved tools in AKI and are delighted to be working with OCD to address this important medical condition," said Chris Hibberd, Astute Medical chief executive officer.

"Astute's innovative approach and product is a perfect fit with the commercial strength of OCD and our desire to advance important new diagnostic tests," commented Dr. Martin D. Madaus, OCD chairman and chief executive officer.

About Astute Medical, Inc.
Named by the Wall Street Journal as one of the Top 10 Healthcare Start-Ups of 2012, Astute Medical is dedicated to improving the diagnosis of high-risk medical conditions and diseases through the identification and validation of protein biomarkers that can serve as the basis for novel diagnostic tests. The Company's focus is community and hospital-acquired acute conditions that require rapid diagnosis and risk assessment. Astute Medical's current areas of interest include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. 

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About Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. delivers high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho-Clinical Diagnostics also brings sophisticated information management, testing technologies and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit

Astute Medical®, the AM logo, Astute140®, NephroCheck® and the NephroCheck logo are registered trademarks of Astute Medical, Inc. in the United States. AKIRisk™ is a trademark of Astute Medical, Inc. in the United States. For information regarding trademarks and other intellectual property applicable to this product, including international trademarks, please see Astute Medical, Inc., PN 0312 Rev A 2014/07/22

1 Chawla LS, Amdur RL, Shaw AD, Faselis C, Palant CE, Kimmel PL. Association between AKI and long-term renal and cardiovascular outcomes in United States veterans. Clin J Am Soc Nephrol. 2014 Mar;9(3):448-56. doi: 10.2215/CJN.02440213. Epub 2013 Dec 5.

SOURCE Astute Medical, Inc.