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DiaSorin, MeMed Obtain CE Mark for High-Throughput Immune-Response Assay

NEW YORK ─ DiaSorin and MeMed on Tuesday announced they have obtained CE marking for a high-throughput, immune-response assay called Liaison MeMed BV and launched it in countries that accept the designation.

The Liaison MeMed BV test is a fully automated, chemiluminescent immunoassay that uses host-response data to enable physicians to differentiate between bacterial and viral infections, supporting fast and better-informed treatment and patient management decisions, the firms said.

The test detects three soluble proteins — TNF-related apoptosis-induced ligand, interferon gamma-induced protein-10, and C-reactive protein — to determine a patient's immune response to an infection.

By relying on the immune response, the assay complements conventional technologies, enabling better informed antibiotic and antiviral treatment decisions and allowing for rapid and accurate diagnosis, the firms said.

Its CE marking and launch follow a licensing agreement announced in September 2020 by which Saluggia, Italy-based DiaSorin obtained the rights to commercialize and make the MeMed BV test available on its Liaison XL and Liaison XS platforms.

The firms anticipate obtaining US Food and Drug Administration clearance for the Liaison MeMed BV assay in 2022.

Haifa, Israel-based MeMed received FDA 510(k) clearance for the MeMed BV test on its MeMed Key platform in September.