A Clinical Lab Strategy Session for 2027

Clinical labs are entering a correction period. For years, panel sizes and data collection expanded faster than payer and regulatory frameworks could adapt. Now, that gap is closing.

In a recent fireside chat, Sam Thompson (Head of Lab Services & Commercial Strategy at OMAPiX) and Tony Mancuso (Director of Business Development at Onymos) worked through exactly what that correction looks like on the ground, and what labs should be putting on their 2027 roadmap because of it.

Optimize for Defensible Claims, Not More Data and Workarounds

The conversation kept coming back to the same planning principle. Volume alone is no longer a sustainable strategy. Sam explains:

“I think the key thing here is that we expanded so rapidly that all of a sudden you have a patient sample testing 50 to 60 different organisms, with 10 to 15 ABR [antimicrobial resistance] targets… Precision medicine is ultimately looking at specific patient populations and what is the clinical claim that you’re trying to make. Instead of broadening the overall panels, we need to reel in exactly what we’re looking at — what are the specific claims per patient, and the specific demographic you’re looking at, for precision medicine’s sake. Right now, there’s a lot of push to continue to expand and generate more data, but the data is irrelevant if it’s not relevant to the clinical claim that it’s making.”

Tony added:

“The medical necessity thing really becomes a key player in this, because I think what you’re seeing too is the payers not paying for those large panels, because part of those panels are not quote-unquote medically necessary.”

Some labs responded to stricter billing requirements by relocating to friendlier billing regions instead of proving clinical utility. Sam saw this firsthand in Utah:

“We primarily ran into a lot of trouble my first while back in Utah… we were part of the MolDX infrastructure for CMS. And there, they were the first ones to implement a new billing system, which required a Z-code in order to bill for a molecular assay. For this molecular assay, for the Z-code, you needed to establish a clinical claim, and that included a technical assessment, which included clinical validity and clinical utility of the assay.

“A lot of labs were not getting approved for that testing… A lot of labs ended up picking up their lab and moving it outside of the MolDX regions, and start testing the [CPT code] 87798 over and over and over again until you got paid $700 for a UTI test.”

All of this is exactly what’s drawing industry-wide scrutiny now, as MolDX-style, case-by-case technical assessments spread into private payers. As Sam put it, this is increasingly becoming the standard, not the exception:

“I think a lot of the technical assessments will be implemented in a lot of the private payers. I think United has already started talking about implementing it or have already implemented it.”

Budget for AI Validation, Not AI Shortcuts

On artificial intelligence, Sam’s starting point was that adoption is inevitable. But that doesn’t mean AI should be held to a different standard than any other diagnostic technology:

“I personally see it as sort of a copilot to start, not a full implementation… We won’t lower the bar for AI validation for a clinical setting. We just have to revamp and reorganize what that validation will look like.”

That reorganization, he argued, is where the industry currently falls short. For starters, the foundations of CLIA and CAP are decades old:

“This is where we get into the outdatedness of the CLIA CAP regulations that are implemented into now the molecular and precision medicine field, because our tests are now a lot more complex. Bioinformatics is involved, precision medicine is now evolving. What does that look like for our regulatory bodies to implement AI precision medicine and expand on clinical claims?”

Build Your Peer Network Before You Need It

The conversation wrapped up with trying to answer the session’s most practical question. How does a lab stay current when everything around it is moving this quickly?

Tony asks:

“There’s so much information, there’s so much moving in this entire space… As an individual lab that’s siloed within their own business, what are some resources or things that you’ve found that have helped?

“…One of the conferences we go to is the Executive War College. And that one is great because it’s just genuinely everyone just putting their guard down. It’s lab leaders across the country, and they just share ideas. And I think that’s a great forum — but the problem is it’s once a year, and you’re not catching everybody while you’re there.”

Sam replied that no lab can figure this all out on their own:

“Continue to ask questions, continue to be curious… continue to rely on other laboratory directors, other clinical guidance, FDA, obviously regulations… CAP, New York State — they all provide their own individual newsletters, CMS obviously too… if we come together over the course of the next couple of years, we’re going to come out stronger.

What This Means for Your 2027 Roadmap

Defensible claims, budgeting for AI tools and copilots, and building peer-to-peer relationships that catch industry shifts in real time (not once a year at a conference) will separate the labs that stay ahead of regulatory and reimbursement pressure from the ones forced to react to it.

…And Tony and Sam’s full conversation goes even deeper. We couldn’t fit it all here. Don’t miss out, and watch the whole fireside chat on YouTube (or below).