Cytovale’s Early Sepsis Diagnostic Test Gets 510(k) Clearance

January 20, 2023

Cytovale’s IntelliSep has received 510(k) clearance from the FDA for early diagnosis of sepsis, a severe autoimmune response to an infection, which can be far more life-threatening than the original illness that triggered it.

The test provides results in under 10 minutes from a standard blood draw and classifies patients into three groups according to their probability of sepsis from low to high probability.

The risk of death from sepsis increases by as much as 8 percent each hour the condition goes untreated, making early detection critical for improving patient outcomes.

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