FDA OKs Astute Medical’s First Diagnostic for Acute Kidney Injury

Astute Medical NephroCheck (Astute image used with permission)

San Diego-based Astute Medical, founded in 2007 to identify and validate protein biomarkers that can be used to improve the diagnosis of high-risk medical conditions, says the FDA has cleared its new test for detecting acute kidney injury (AKI).

In a statement Friday, the FDA said the first-of-a-kind lab test can help determine if certain critically ill hospitalized patients are at risk of developing moderate-to-severe AKI in the 12 hours following the test.

The company says its biomarker-based immunoassay, called NephroCheck, will go on sale in coming weeks via a strategic partnership with New Jersey’s Ortho-Clinical Diagnostics. NephroCheck detects the presence of certain proteins (insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases 2) in the urine that are associated with acute kidney injury.

Astute says NephroCheck is the only diagnostic test available in the United States to assess the risk of AKI, which is characterized by a sudden decline in kidney function, which often begins without symptoms while a critically ill person is hospitalized for trauma, major surgery, infection, or some other condition. Current laboratory tests only assess whether a patient already has AKI. NephroCheck provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed.

“It’s really a severe condition, and things could be twice as bad if you develop it,” says Astute co-founder and CEO Chris Hibberd. Hospitalizations last twice as long, on average, for patients who develop AKI, and their healthcare costs are typically more than double, Hibberd said. Hospital re-admissions occur twice as frequently for AKI patients and the one-year mortality rate also is about double for AKI patients.

Astute Medical’s diagnostic test represents the first real improvement in renal testing in over 60 years, Hibberd says.

Of 5 million patients admitted to hospital intensive care units in the United States each year, Astute says roughly half will develop moderate to severe AKI. Calling acute kidney injury “the most deadly

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Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.