McGowan Institute for Regenerative Medicine
affiliated faculty member John Kellum, MD (pictured), professor of critical care medicine at the University of Pittsburgh, transplant physician in anesthesiology at the Thomas E. Starzl Transplantation Institute, and co-director at the Mechanisms and Novel Therapies for Resuscitation and Acute Illness (MANTRA) Lab, was the lead investigator of a now FDA-approved lab test that 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 Dr. Kellum. "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 first biomarker-based immunoassay, called NephroCheck, was developed by San Diego-based Astute Medical Inc. 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."
Illustration: McGowan Institute for Regenerative Medicine.
San Diego Business Journal (09/08/14)
Pittsburgh Business Times (09/15/14)
Bio: Dr. John Kellum