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The system is designed to provide a quantitative determination of red blood cells and total nucleated cells in CSF.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
Immunovia said that the NYU School of Medicine has joined PanFAM-1, a prospective study investigating early diagnosis in high-risk individuals with familial pancreatic cancer.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.
McKesson will exclusively distribute Sysmex's XW-100 system, a CLIA-waived complete blood count diagnostic instrument starting in the spring.
One firm, Exosome Diagnostics, is working to streamline payor coverage for a commercial test, and researchers are simultaneously developing promising ways to isolate exosomes.
Microgenics, Astute Medical, and Siemens were among the firms whose tests and/or systems were cleared by the FDA for marketing last month.
Sysmex said that in 2018, it will replace LifeLabs' hematology analyzers at 12 sites throughout British Columbia and Ontario and provide scalable solutions.
The alliance follows a marketing deal signed with Sysmex Europe that covers Europe, the Middle East, and Africa.
The XW-100 Automated Hematology Analyzer previously received 510(k) clearance. With the CLIA waiver, the test can be run in more types of healthcare facilities.