,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. 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.