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# HelixBind Gets Breakthrough for Sepsis Test
- URL: https://www.fdaweb.com/helixbind-gets-breakthrough-for-sepsis-test/
- Published: 2020-08-24T12:00:00.000Z
- Updated: 2026-09-14T16:26:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147499

FDA has awarded HelixBind a breakthrough device designation for its RaPID/BSI, a direct-from-blood platform for identifying and characterizing bloodstream infections, such as sepsis. HelixBind says its breakthrough request focused on the features of the RaPID platform that distinguish the test from the current standard of care, such as a fast turnaround time of a few hours, a panel of 21 bacterial and fungal pathogens covered by a single test, and the test’s sensitivity to identify very small concentrations of pathogens contained within a blood specimen.