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Biocartis, Immunexpress Ink Co-Commercialization Agreement for Sepsis Test

NEW YORK – Biocartis has expanded its current partnership with Seattle-based Immunexpress by launching a co-commercialization agreement for Immunexpress' SeptiCyte Rapid test on Biocartis' Idylla platform.

As part of the expanded collaboration, Biocartis will lead commercialization in Europe as the exclusive distributor of the SeptiCyte Rapid test, while Immunexpress will lead commercialization of the test in the US.

Immunexpress also noted today that it has received the CE mark for the SeptiCyte RAPID test on the Idylla platform. The firm aims to receive 510(k) clearance from the US Food and Drug Administration by Q3 2020.

Immunexpress' SeptiCyte Rapid Test uses RT-PCR to distinguish sepsis from infection negative systemic inflammation in patients suspected of sepsis, providing actionable results to clinicians for patient management decisions in about an hour. The firms believe that early diagnosis of bacterial and viral sepsis with SeptiCyte Rapid — including the need to triage COVID-19 patients with declining prognosis —will allow quick initiation of sepsis management and increase the potential to save patient lives.

"Although our focus remains in oncology, we currently see high unmet needs in the field of infectious diseases that we can help address with our Idylla platform," Biocartis CEO Herman Verrelst said in a statement. "The expansion of our partnership with Immunexpress also allows us to make the necessary adjustments to minimize a potential impact on our business, linked to the disruptions in our commercial operations and the uncertainties caused in the market by the COVID-19 pandemic.”

Financial details of the agreement were not disclosed.

"I believe Biocartis, with its well established and growing Idylla customer base will be highly effective in delivering to the European community a new and novel sepsis diagnostic tool …  to improve clinical outcomes and to lower healthcare costs," Immunexpress CEO Rolland Carlson said in a statement. "Together, we are committed to mitigating the constraints on hospitals that are affected by the COVID‑19 pandemic by more accurate diagnostic testing of sepsis, which is expected to enable physicians to make rapid clinical decisions in resource-constrained ICUs."