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

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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.”

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