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 disease you’ve never heard of,” Astute says AKI incidence in the United States is believed to exceed that of heart attacks.

In a statement from the company, Kianoush Kashani of the Mayo Clinic, says, “Clinicians will be able to integrate the test with clinical information to improve decision-making, which aligns with the goal of offering better preventive care and earlier action.”

While Astute’s NephroCheck has been available in Europe since early 2013, Hibberd said the FDA’s clearance has triggered “a big commercialization effort” in both the United States and Europe. While Ortho-Clinical Diagnostics is the exclusive sales agent in both markets, Hibberd said Astute plans to hire 25 of its own sales reps. Astute currently has 50 employees.

Astute also will be working with Ortho-Clinical to develop an automated version of the AKI diagnostics test. The goal of developing an automated diagnostic test would be to improve the lab workflow as physicians order AKI tests more routinely at hospitals, clinics, and other institutions, Hibberd said.

As part of their strategic collaboration, which Astute and Ortho-Clinical disclosed in July, Ortho-Clinical made a $15 million equity investment in Astute. The Carlyle Group acquired Ortho-Clinical Diagnostics from Johnson & Johnson for $4.15 billion earlier this year, and has been revamping the business as an independent, stand-alone company based in Raritan, NJ.

Astute Medical has raised more than $100 million since it was founded, Hibberd said. In addition to Ortho-Clinical, Astute says its investors include De Novo Ventures, Delphi Ventures, Domain Associates, Kaiser Permanente Ventures, and MPM Capital.

Hibberd and co-founder Paul McPherson previously worked together at San Diego-based Biosite to develop immunoassay diagnostics for heart patients. Inverness Medical Innovations, the Waltham, MA-based company now known as Alere (NYSE: ALR), acquired Biosite in 2007 for close to $1.7 billion.

Hibberd and McPherson started Astute Medical later that year, with the idea of developing biomarker-based diagnostics in five disease areas. With the rollout of the AKI test now underway, Hibberd said the company is turning its attention to developing diagnostic for other incipient medical conditions, including strokes, heart attacks, abdominal pain, and sepsis.

“We actually have a pipeline of other diagnostic tests,” Hibberd said. “Our goal is to [introduce] a new test every year.”