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Immunexpress Looks To Leverage U.S. Anti-Infection Incentives With Unique Sepsis Diagnostic

The Seattle company's SeptiCyte system is designed to directly quantify molecular markers of sepsis from patient blood samples and tell doctors the probability that a patient has sepsis within four hours, allowing for aggressive treatment of sepsis or, if the test result is negative, preventing unnecessary antibiotics.

Seattle-based startup Immunexpress is set to complete an FDA de novo filing for its SeptiCyteLab sepsis test that it says tells the physician the probability the patient has sepsis within a few hours. That would be a big step up from current sepsis diagnostics that can take over a day to complete and often provide no useful information, the firm says.

The company hopes FDA will clear SeptiCyte Lab by the end of 2015 with a market launch set for the second half of 2016. Immunexpress is also working on a...

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