Seattle-based start-up Immunexpress Inc. is set to complete an FDA de novo filing for itsSeptiCyte Lab sepsis test that it says tells physician with a few hours the probability that a patient has sepsis. 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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