Ortho Clinical Diagnostics Signs Agreement with Astute Medical, Inc. to Commercialize and Develop Innovative Acute Kidney Injury Tests

Ortho Clinical Diagnostics Signs Agreement with Astute Medical, Inc. to Commercialize and Develop Innovative Acute Kidney Injury Tests

Jul 28, 2014

Raritan, NJ, July 28, 2014 – Ortho-Clinical Diagnostics, Inc. (OCD) announced it has entered into a strategic partnership with Astute Medical, Inc., under which OCD will become the exclusive commercial partner for the distribution of Astute’s NephroCheck® Test and Astute140® Meter in certain markets in Europe and, pending FDA clearance, the United States. On June 30, 2014, OCD became an independent, stand-alone diagnostics company with a renewed commitment to expand market reach with differentiated platforms and menus to better serve lab customers.


The NephroCheck® Test and Astute140® Meter are used in a hospital setting to assess critically ill patients for risk of acute kidney injury (AKI), an increasing burden worldwide that can lead to poor patient outcomes and increased healthcare expenditures if not detected at an early stage.


“Our collaboration with Astute Medical is aligned with OCD’s focus on providing access to the differentiated innovation that enables our customers to better address and manage critical healthcare needs,” said OCD Chairman and Chief Executive Officer Dr. Martin D. Madaus. “This commercial and development alliance will expand OCD’s ability to meet the needs of our customers and we are pleased to announce this agreement with Astute early into our existence as a stand-alone company.”


“We are delighted to partner with OCD and see great potential to expand access to Astute Medical’s innovative kidney injury assessment tools through their commercial reach and unique development capabilities,” said Chris Hibberd, Astute Medical Chief Executive Officer.


Under the agreement, OCD also receives a semi-exclusive license to develop, manufacture and sell the NephroCheck® Test for use on its VITROS® line of automated, high-volume testing platforms. In addition, as part of this strategic agreement, OCD has made a $15 million equity investment in Astute Medical. Astute will be responsible for manufacturing the Astute NephroCheck® Test for use on theAstute140® Meter in all markets and will collaborate with OCD on the sale of the NephroCheck® Test.


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 www.orthoclinical.com.


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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