SeptiCyte RAPID receives 510(k) clearance by FDA

Dec. 2, 2021

Biocartis Group NV, based in Mechelen, Belgium, said that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for SeptiCyte Rapid.

SeptiCyte RAPIDis a fully automated, rapid host-response test that distinguishes sepsis from infection-negative systemic inflammation in patients suspected of sepsis. It provides results in about one hour.

This test runs on Biocartis’ rapid molecular diagnostics Idylla platform2 and was developed under Biocartis’partnership with Immunexpress, a Seattle-based molecular diagnostic company focused on improving outcomes for suspected sepsis patients.

“Today, diagnosing sepsis is challenging because conventional techniques — such as blood culture or the detection of sepsis-related biomarkers such as lactate and procalcitonin — are slow and often not very accurate,” Biocartis said.

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