So, You're Consolidating Molecular Platforms: Here's What to Consider

Contributing Lab Leaders: Frederick S. Nolte, PhD, D(ABMM), F(AAM) and John Longshore, PhD, FACMG

Operational

Article highlights:

Many labs are moving to consolidate testing on new workhorses that can accommodate larger menus.
When considering a workhorse, labs should think not only about their full test menus, but also their future development pipeline.
For consolidation, redundancy and rapid manufacturer support must be taken into account.

"When you go into the traditional molecular pathology lab, you find that it's—how do I say this? Instrument rich," says Dr. Frederick Nolte, professor and vice chair for Laboratory Medicine and director of Molecular Pathology at the Medical University of South Carolina. It's well known that molecular labs often maintain quite a few varieties of testing equipment, which may only perform two or three tests apiece. This is hardly a sustainable path forward, for time- and budget-crunched lab managers.

However, with testing menus growing in size and scope, particularly in infectious disease, lab leaders have the opportunity to consolidate more testing on fewer, high- volume workhorse platforms. For many lab leaders, this is an appealing route. But platform consolidation comes with many options to weigh and consider. Here, lab leaders discuss what molecular labs need to know as they determine a consolidation plan.

Accommodating Your Test Menu

Of course, when reviewing a platform, the first question you should ask is, "Can it perform the tests I need?" Dr. John Longshore, director of molecular pathology at Carolinas Pathology Group, Atrium Health, elaborates: "Platform consolidation ... really changes the way you look at your menu. You're not buying an instrument for a single test, but looking at the entirety of your menu and the future pipeline for development on that instrument."

The first point, and Dr. Nolte agrees, is that lab leaders should ensure that the instrument can accommodate full spectrum of their menu—which may include not only a broad range of FDA-cleared tests, but also the many laboratory-developed tests that labs support, such as esoteric viral load tests or even off-label uses of IBB tests for varying types of samples.

That second point—ensuring robust future development pipeline—is also key. Lab leaders need to consider not just what their platform can offer patients and physicians today, but how its use can evolve over the coming years. In other words, for platform consolidation to be successful, your workhorse must be able to accommodate change with a promising development portfolio.

On Changing the Way You Look at Your Menu

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John Longshore, PhD, FACMG

Director of Molecular Pathology

Carolinas Pathology Group, Atrium Health, Carolinas HealthCare System

Ensuring Redundancy and Robust Support Services

One critical factor in platform selection is how labs will avoid downtime during trying moments. The first point to consider—should your lab require it—is redundancy. Ideally, labs would have multiples of the same instrument, in the event that one goes down. But, for reasons of space and resource, this isn't always possible.

However, many automated platforms today have redundancy features built into a single unit. For instance, instruments may have multiple thermocyclers for amplification, or multiple channels for samples to flow through. For lab leaders, these features are something to consider carefully. "The ability to have built-in redundancy is something that I think is a very powerful and very attractive sales feature for a manufacturer," says Dr. Longshore.

Meanwhile, lab leaders should also ensure that they receive adequate support services from a manufacturer, in the event of system malfunctions. Here, Dr. Longshore advises that labs work with trusted equipment suppliers. "That's the importance of working with an established manufacturer. If you do not have redundancy or have a single instrument, they better have their repair people available almost instantaneously with the parts you need to get your workhorse up and running again," he says.

Of course, a lab's need for redundancy and rapid support will depend on the turnaround times required for particular tests. Dr. Nolte mentions, for instance, that while CMV viral load tests cannot experience downtime because results need to be rapid, other things, like HIV viral load tests, are under less pressure, because they may not be needed for several weeks. "That figures, I think, into the decision about whether or not you can tolerate a delay in delivering those results if you only have a single system," he says. Again, redundancy and reliable support will be critical for tests that require quick, consistent turnarounds.

On the whole, consolidating testing to fewer platforms can be a complicated endeavor. However, when lab leaders carefully evaluate their current and future testing menu needs, along with requirements for redundancy and rapid support, they can more easily find a manufacturer and workhorse that suits their lab. Over the long term, it is an effort that can save time and money for "instrument rich" molecular labs, putting them on a more sustainable path toward success.