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

Xconomy San Diego — 

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 … Next Page »

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