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Tag Archives: BioMerieux—

FDA clears BioMérieux culture bottles

March 2019—BioMérieux’s BacT/Alert BPA and BPN culture bottles have received 510(k) clearance from the FDA. The culture bottles are for quality control testing of leukocyte-reduced apheresis platelet units and support the growth of aerobic and anaerobic microorganisms in two types of leukocyte-reduced units: apheresis platelet units and both single and pools of up to six units of whole blood platelet concentrates.

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MALDI-TOF for the clinical identification of mycobacteria

Webinar presenter Omai Garner, PhD, D(ABMM), Assistant Clinical Professor, Section Chief, Clinical Microbiology, Director, Point of Care Testing, UCLA Department of Pathology and Laboratory Medicine,  discusses the implementation and clinical use of MALDI-TOF MS for mycobacterial identification. It covers in detail the clinical data surrounding organism identification. It also explores the lab protocol (workflow impact) and turnaround time improvements (clinical impact) for this new technology. This on-demand webinar originally broadcast on December 13, 2018.

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BioFire unveils Salt Lake City facility, 7/17

July 2017—BioMérieux announced that BioFire Diagnostics, its molecular biology affiliate, celebrated the opening of its Alain Mérieux Center for Molecular Diagnostics facility in Salt Lake City. The facility, home to more than 1,000 employees, is dedicated to the development of FilmArray, BioFire’s molecular PCR multiplex system for the syndromic diagnosis of infectious diseases.

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Brahms PCT OK’d as aid in antibiotic stewardship

March 20, 2017—BioMérieux received 510(k) clearance from the Food and Drug Administration for the expanded use of its Vidas Brahms PCT, an automated assay measuring procalcitonin levels, to help clinicians make decisions about the use of antibiotics in two clinical situations: lower respiratory tract infections and sepsis. It’s the first test to use PCT as a biomarker to aid in ...

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Jackson Laboratory, BioMérieux form partnership

Sept. 12, 2016—The Jackson Laboratory has entered into a sponsored research agreement with BioMérieux to develop more precise diagnostics for pathogens and their antimicrobial resistances in infectious diseases. BioMérieux will work with the laboratory of George Weinstock, PhD, director of microbial genomics at Jackson Laboratory. Under the research agreement, Jackson Laboratory and bioMérieux will seek better methods to identify individuals ...

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BioTheranostics leaves BioMerieux fold

Feb. 4, 2016—Molecular diagnostics company BioTheranostics announced has closed a $32 million financing led by MVM Life Science Partners, with participation of Canepa Advanced Healthcare Fund and HealthQuest Capital. As a result of the financing, BioTheranostics will be spun out from BioMerieux, which will remain a minority shareholder, and operate as an independent company. “This is an exciting new beginning ...

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FDA clearance for BioMérieux products, 9/15

BioMérieux announced the FDA 510(k) clearance and commercial availability of Vidas 3, the new generation of Vidas. Vidas 3 features enhanced automation, in particular the preanalytical section from the barcoded primary tube including dilution, improved traceability, and new software capabilities, as well as a quality control program in compliance with laboratory certification standards. Vidas 3 is CE marked and registered at the Chinese Food and Drug Administration.

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