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DiaSorin Gains CE Mark for Sepsis, Severe Infection Assay

NEW YORK – DiaSorin said Tuesday that it has secured CE marking for an immunodiagnostic assay to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections, and the firm is launching the assay in Europe.

Saluggia, Italy-based DiaSorin said the Liaison BRAHMS MR-proADM chemiluminescent immunoassay assesses the MR-pro-ADM biomarker released during inflammatory responses and infections. The results can be used to stratify patients by disease severity and the risk of unfavorable outcomes and are intended for use with other clinical findings to help physicians improve patient triage and provide more precise therapies, it said.

The test measures MR-pro-ADM in human plasma and is designed for use by CLIA-certified laboratories on DiaSorin's Liaison instruments. DiaSorin and Waltham, Massachusetts-based Thermo Fisher Scientific in May 2022 said they were partnering on the development and commercialization of a Liaison BRAHMS MR-proADM immunodiagnostic test that would offer more precise assessments of disease severity. The firms at the time planned for a European launch in Q1 2023 and US launch in the second half of 2024.

Chen Even, chief commercial officer for DiaSorin, said in Tuesday's announcement that the launch of the assay with Thermo Fisher Scientific confirms DiaSorin's ability to expand its offerings of innovative specialty tests with high medical value.

"We are confident that the new test will support clinical decision making as well as optimize critical care resourcing, the latter being a key objective to improving healthcare systems," he said.