Hematology Will Play - Roche Moves Closer to High-Growth Core Lab Market Segment

Hematology Will Play - Roche Moves Closer to High-Growth Core Lab Market Segment

This blog updates developments in the markets for hematology and core lab diagnostics comprehensively covered in the Kalorama Information reportsThe World Market for HematologyandThe Worldwide Market for In Vitro Diagnostic Tests, 9th Edition.

True to its name, Roche’s Bloodhound technology is on the trail of a conspicuously high-growth market segment in hematology testing. Digital cell imaging and morphology analysis is a significant addition to conventional core lab hematology capabilities of automated cell counts and differentials. The leader in this market space is specialist CellaVision, which has averaged roughly 13% annual growth over both the last two years and four years (2012-2014; 2010-2014). In North America, CellaVision has accomplished average annual growth of approximately 18% since 2010. With few other competitors in digital cell imaging for clinical hematology, Roche’s recent unveiling of its Bloodhound digital cell imaging technology -as newly integrated into the cobas m 511 hematology analyzer -is notable as a play to not only capture growth enjoyed by CellaVision, but also compete more broadly in core lab hematology.

Demand for core lab automation is seemingly unquenchable, limited only by the diminishing compromises to testing accuracy, sensitivity, or reliability. The last domain in lab hematology outside the reach of automation has been manual review and manual differentials. The discriminatory abilities of impedance- and laser light scatter-based analyzers remain limited by sampling errors, calibration errors, interfering substances, and the absence of distinguishing cell features detectable by volume or light scatter. Automated visual analysis overcomes the limitations of analyzer differentials and potential errors of laborious manual differentials. Manual review of slided and stained blood samples is taxing in terms of lab personnel time and its estimation principles very limited compared to high-speed neural networking available on digital cell imaging platforms. Automation is becoming increasingly indispensible to labs managing relatively high volumes of flagged blood samples.

The ambitions of Roche Diagnostics in hematology are clearly indicated in the capabilities of the cobas m 511. The instrument addresses the entire core lab hematology station workflow -slide making; slide staining; complete blood count (CBC); differentials; and streamlined, software-assisted manual review of slided, stained and imaged cells. The system replaces inconsistent wedge smearing with needle-guided uniformly printed blood in order to produce consistent results and distinguish cells. The slides are stained and the cells then spectrally and visually analyzed to yield 26 CBC and differential parameters. Cell morphology can be reviewed at the workstation or remotely by a pathologist for more demanding diagnoses.

The scope of the cobas m 511 contrasts to that of CellaVision’s DM1200 and DM9600 cell imaging systems. CellaVision systems only perform cell morphological analysis of blood and body fluid smears as well as differentials. Coordinated CBCs and analyzer differentials are available from major CellaVision distribution partners and hematology analyzer vendors Sysmex, Beckman Coulter, Siemens, and Abbott. The cobas m 511 will effectively target the entire workflow represented by competitors’ partnered solutions with CellaVision. The instrument’s market launch will ultimately reveal where placements are likely to predominate, though Kalorama Information expects the greatest success in centralized network and reference laboratories responsible for samples of patients with blood cancers, hemoglobinopathies, and immune system disorders. More distributed placements are possible due to the smaller footprint of the cobas m 511, but will be contingent upon the price of the system. Regardless, Roche’s already omnipotent presence in IVD is set to expand as it enters the field of lab hematology.

For further insights into core lab testing, including hematology, Kalorama Information offers The World Market for Hematology, The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition, and The Market for Clinical Chemistry.