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FDA Clears Roche's Hematology Testing Solution

NEW YORK (360Dx) – Roche today announced the US Food and Drug Administration has cleared its Cobas m 511 hematology testing solution.

The analyzer combines a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution, enabling laboratories to report the complete blood count, white blood cell differential and reticulocyte results, as well as prepare, stain, and analyze blood smears for abnormal results thorough a single process, Roche said.

Using Roche's Bloodhound technology, the Cobas m 511 uses 30 microliters of blood to print a monolayer onto the slide, "stains with an improved method for further analysis of the morphology and enables classification of cells displayed on a viewing station," the company said.

The instrument received CE marking in January 2017, bolstering Roche's footprint in the hematology market.

In a statement, Roche Diagnostics CMO Alan Wright said that 1 in 76 people in the US are born with a blood disorder, "making this aid in the diagnosis of blood diseases like anemia and leukemia a significant advancement."