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BioMérieux Gets CE Mark for B12 Assay

NEW YORK – BioMérieux announced on Tuesday that it has obtained the CE mark for an assay to detect vitamin B12. The automated, quantitative test runs on the firm's Vidas immunoanalyzers.

Vitamin B12 deficiency is associated with anemia and neurological symptoms including cognitive and gait impairments. The Vidas Vitamin B12 Total assay measures total B12 levels in blood serum or plasma from adults with a suspected B12 deficiency or who are at risk for low B12 levels. The test adds to the firm's menu of anemia-related Vidas assays, BioMérieux said in a statement, and completes its menu of routine tests for the system.

Jennifer Zinn, executive VP of clinical operations at BioMérieux, said that Vidas is a core focus of the firm's immunoassay strategy as it enters a fourth decade since its launch. "Vitamin B12 Total perfectly complements our comprehensive Vidas portfolio that also includes infectious diseases, emergency, and critical care assays," Zinn said. "The launch of Vidas Vitamin B12 Total is a testament to BioMérieux's ongoing commitment to provide value-add diagnostic solutions to lab and healthcare professionals for optimized patient care."

BioMérieux offers a high-throughput benchtop lab system called Vidas 3 and also launched a smaller, modular system called the Vidas Kube at the end of 2022.

The Vidas Vitamin B12 Total assay is expected to launch in selected countries at the end of 2024, followed by an extended rollout in the first quarter of 2025.