Pharmaceuticals company Roche (SIX:RO)(OTCQX:RHHBY) reported on Thursday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for its new integrated digital hematology testing solution, the cobas m 511 analyzer.
The company's new cobas m 511 analyzer is a combination of a cell countre, slide maker, stainer and a digital morphology analyzer into one integrated solution. The upgraded version features a patented Bloodhound technology to address the challenges of hematology testing.
In conjunction, the patented Bloodhound technology uses only 30μl 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, added the company.
Following the US FDA approval, the laboratories can report the complete blood count (CBC), white blood cell differential and reticulocyte results as well as prepare, stain and analyze blood smears for abnormal results through a single, integrated process. The clinicians will benefit from integrated workflow and faster access to abnormal results.
Hematology is practised by specialists in the field who deal with the diagnosis, treatment and overall management of people with blood disorders ranging from anemia to blood cancer, concluded the company.
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon