Astute Medical Inc. Receives FDA Clearance for Biomarker-Based ImmunoassayMonday, September 8, 2014
San Diego-based Astute Medical Inc. today announced that it has received clearance from the Food and Drug Administration to commence sales of its first biomarker-based immunoassay, NephroCheck.
The test will be used to help determine if critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
"I'm delighted at the emergence of new tools that may help improve care for patients at risk for AKI," said John Kellum a critical care physician at University of Pittsburgh Medical Center and principal investigator. "While more physicians are aware of the need to assess patient risk for AKI, we have lacked a reliable method of performing this risk assessment."
The 510(k) clearance through the FDA clears the path to commence sales in the coming weeks with its partner Ortho-Clinical Diagnostics Inc., whom Astute Medical has designated as the exclusive sales agent for Astute's NephroCheck Test.
"Astute is committed to developing innovative tests to provide better health care. We are excited to introduce the first real improvement in renal testing in over 60 years," said Chris Hibberd, Astute Medical chief executive officer. "Together with our partner, Ortho Clinical Diagnostics, we look forward to making the NephroCheck Test System available. We thank our employees and clinical investigators who helped make this important advancement in AKI."