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