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Immunexpress Receives FDA 510(k) Clearance for Sepsis Assay

The story has been corrected to say Immunexpress, not Biocartis, received FDA clearance for the SeptiCyte Rapid sepsis assay.

NEW YORK – Belgium-based molecular diagnostics company Biocartis said on Tuesday that Immunexpress has received 510(k) clearance from the US Food and Drug Administration for its SeptiCyte Rapid sepsis assay.

The test, which distinguishes sepsis from noninfectious systemic inflammation in patients suspected of having sepsis, was launched in October 2020 as a CE-IVD-marked assay. It runs on Biocartis' rapid Idylla platform and provides results in about one hour, Biocartis said.

SeptiCyte Rapid was developed under Biocartis' partnership with Seattle-based molecular diagnostic company Immunexpress. In September 2020, the companies said they were positioning the test as a way to triage COVID-19 patients who could be at greater risk for progressing to sepsis. Biocartis also sells a diagnostic for SARS-CoV-2 and planned to market both tests for use on the Idylla system.

"Following the commercial launch of this test in Europe a year ago, the 510(k) clearance by the US FDA now enables the full commercial rollout by Immunexpress in the US," Biocartis CEO Herman Verrelst said in a statement. "This shows how our partners can really benefit from developing their test content on our decentralized Idylla platform. For Biocartis, the commercialization efforts in the US are expected to expand the Idylla installed base and to strengthen cartridge volume growth."