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Immunexpress Nabs 510(k) Clearance for EDTA Blood-Compatible Cartridges

NEW YORK – Immunexpress announced Thursday that it has secured US Food and Drug Administration 510(k) clearance for ethylenediaminetetraacetic acid (EDTA) blood-compatible cartridges for use with the firm's SeptiCyte Rapid test to differentiate sepsis from infection-negative systemic inflammation.

SeptiCyte Rapid is a blood-based RT-qPCR test that is used to assess patients with suspected sepsis within their first day following ICU admission by quantifying mRNA transcripts of host response genes PLA2G7 and PLAC8 and determining their relative expression levels. The test runs on Biocartis' Idylla instrument, and the firms have partnered to sell the platform with the test.

Immunexpress began commercializing SeptiCyte Rapid in early 2023 after it secured FDA clearance for use of the test in the US with venous blood samples that were collected in PAXgene Blood RNA tubes.

The test has been available in Europe since 2020, and Immunexpress announced in August 2022 that it had launched its SeptiCyte Rapid EDTA blood-compatible cartridges for use in the European market.

The firm said Thursday that allowing use of undiluted EDTA blood samples will help the firm secure more widespread adoption of the test.

"The ability to utilize undiluted EDTA blood samples with SeptiCyte Rapid in the US healthcare system will improve ease of use in the clinical setting," Immunexpress CEO Rollie Carlson said in a statement. "The updated SeptiCyte Rapid EDTA cartridges add additional utility to our diagnostic technology by allowing the use of small volumes of blood with minimal processing required and will promote wider adoption in healthcare systems across the US."