Hematology On the Move at AACC Convention

By Emil Salazar

At the AACC expo, as in the lab, space is limited. Core lab automation, pre/post analytical add-ons, new molecular and immunochemistry analyzers and instruments crowd a mainstay of clinical diagnostics in hematology. Spearheaded by molecular diagnostics, immunodiagnostics and other facets of clinical testing feature increasing sophistication and new applications. Pressures such as a declining medical technician (medtech) workforce and tightening budgets have also come to bear on clinical labs. In such an environment,

hematology vendors have emphasized automation, other process cost savings, and integration. Pre- and post-analytical hematology work, including slide making and staining, manual differentials and cell morphology, have undergone automation and integration – similar to most clinical diagnostics segments.

Evident at the recent AACC expo was a push by hematology vendors to increase the value of their propositions in a relatively established lab market and to provide a comprehensive suite of hematology testing options with a smaller footprint and lower personnel demands. Hematology processes from complete blood count (CBC), differentials, slide making and staining, post-analytical differentials and cell morphology are increasingly automated and integrated. Most major vendors supplement their core hematology analyzers with pre-analytical instruments, in-house or partner slide makers/strainers, and third-party digital morphology and cell imaging solutions. Post-analytical image-based differentials and cell morphology have seen greater acceptance among larger clinical labs in the past few years, as rule making allows for client customization and greater comfort with the automation of sensitive differentials used to monitor acutely ill patients during treatment. 

The comprehensive hematology set-up represents a key boost to otherwise static markets, but can be hampered by the high cost and other demands of the system. In some cases, in-lab hematology costs could more than double with higher slide making and additional imaging. Some systems, depending on vendor and partnering instruments, cannot be integrated ideally and do not replicate the modularity of one party-sourced configurations. Lack of lab space and low demand for post-analytical differentials also represent deterrents to the upgrade to more comprehensive systems. To overcome these challenges, Constitution Medical, recently acquired by Roche, has pioneered a promising synthesis of hematology solutions with its Bloodhound platform. 

A Bloodhound system prints a single layer of sampled blood cells onto a slide to complete an image-based CBC and 5-part differential, including reticulocytes, reticulocyte hemoglobin, and nucleated red blood cells. Catalogued cells are also viewable individually. The system provides all the capabilities of a hematology lab set-up including analyzer, slide maker/stainer and digital imaging system within one unit (42” wide and 56” tall). Image-based analysis and counting significantly reduces reagent usage, provides faster results, and further decreases demand on personnel. Eagerly awaited, the Bloodhound system still has yet to be approved by the FDA or become available internationally; its cost and timeline for introduction remain unknowns for the market. For now, hematology maintains with its critical, established role in the lab with only slow expansion in parameters and greater utilization of automation. Bloodhound, though radical in its reimagining of lab hematology, represents only another response to client demands – footprint, automation, integration.

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Emil Salazar is the author of the upcoming Kalorama Information title "Hematology Markets"

AACC Meeting Provides Industry Glance

The very size of the American Association of Clinical Chemistry is a testament to the growth of the IVD industry that Kalorama has covered for decades.  This year's AACC in Houston, TX did not disappoint.   650 companies exhibited, 100 of them were new. 

Key areas of interest were emerging markets for IVD,  Vitamin D's continued role in the face of controversy, and the recent Supreme Court ruling that isolated human DNA cannot be patented.  AACC hosted a panel featuring ACLU Lead Counsel Sandra Park which explored this landmark decision’s impact on modern healthcare in general, and innovation in genetic research and testing in particular. There were other focuses.  We noted increased competition in POC and hematology, which we will be noting in future blog posts.  New tests to detect life-threatening prostate cancer, new cystic fibrosis tests that can be performed at the point of care, and new ways to determine the safety of schizophrenia and bipolar disorder drugs were also features.

For Kalorama, the meeting was a chance to connect with the industry and notice trends.   Look out for future updates about the meeting from our analysts.