This story originally ran on Oct. 15.
Protein diagnostics firm Astute Medical this week received an EU CE mark for its Nephrocheck acute kidney injury risk assessment test and launched sales of the product in Europe.
The test is the first from the San Diego, Calif.-based firm, and uses two urinary protein biomarkers to assess critically ill patients' risk of developing AKI. The test takes roughly 20 minutes to produce results, the company said.
Nephrocheck runs on Acute's point-of-care immunoassay platform, the Astute140 Meter, a device that converts fluorescent signals for specific biomarkers into concentrations and combines these into a signal numerical test result.
The Astute140 Meter has also received a CE mark. Neither the Nephrocheck test nor the Astute140 Meter are available for sale in the US.
According to Astute, AKI affects up to seven percent of hospitalized patients. The current gold standard for detection is measurement of serum creatinine and urea concentrations. However, this method may not detect kidney injury until 24 to 48 hours after it begins to occur. Therefore, a more rapid detection method is desirable.
Since its founding in 2007 by former Biosite executives Christopher Hibberd and Paul McPherson, Astute's CEO and chief scientific officer, respectively, the company has raised more than $80 million in funding, most recently completing a $40.4 million Series C round that included investors MPM Capital, Kaiser Permanente Ventures, De Novo Ventures, Delphi Ventures, Domain Associates, and Johnson & Johnson Development (PM 6/8/2012).
The firm's focus is on community- and hospital-acquired acute conditions. In addition to AKI its current areas of test development include abdominal pain, acute coronary syndromes, cerebrovascular injury, and sepsis.