Buyer’s guide
The Digital Lab
What it actually takes to get the value out of digital pathology.
Going digital is an operational transformation, not a hardware purchase. This guide lays out what that transformation requires, in the order the work happens: from the chain of custody, through the pathologist’s screen, to the lab-side work that decides whether the investment pays off.
Where to start
Just starting. Part One is the groundwork, and it is the part most vendor content skips.
Scanning already, reading partly digital. Part Two is where most labs stall.
Mostly digital and wondering why it does not feel like it.
Who This is for
The person who has to lead a digital pathology project inside a lab. Usually a lab director, a COO or an owner-operator: someone who does not personally read cases but who has to get pathology, the bench, IT and finance to agree on something none of them will experience the same way.
It assumes you have already decided digital is coming. It does not try to sell you on that. What it does is lay out the work in the order the work actually happens, including the parts vendor material tends to skip because they are not features.
Going digital is an operational transformation, not a hardware purchase.
One honest caveat before you begin: most published digital pathology data comes from academic centers and large networks. Independent and reference laboratories are underrepresented, and their economics are different. Where this guide leans on that data, it says so.
Part One Getting Ready to Go Digital
Buying a scanner turns out to be the easy part. The harder work, and the part most often underestimated, is digitizing the physical chain of custody and the people and systems underneath it. That work is what makes everything downstream reliable, and it is where this guide begins.
1.1 Why Labs Go Digital
Roughly 1 in 10 U.S. labs is digital today. CAP, 2024.
The ones moving now are not doing it for the optics. They are doing it because a pathologist in one city can cover a site in another, because a subspecialist can be consulted in minutes rather than by courier, and because the pathologists they need to hire increasingly trained on a screen and expect to work on one.
The clearest case is logistics. The large networks that went digital earliest were solving a physical problem: glass slides driven across a region every night so a pathologist could read them by morning. Digital removed the courier run overnight. Leaders of those networks tend to describe digital the same way in hindsight, as a foundation rather than an endpoint: hard to justify on a short-term spreadsheet, essential over the long run.
In 2024 CAP introduced new CPT codes that recognize the additional work digitization creates for the laboratory. That is worth sitting with: the body that governs the profession has said, in the most formal way it can, that going digital adds work. The question this guide keeps coming back to is which system carries it.
1.2 What Everyone Needs to Succeed
Every successful rollout we studied says the same thing, and none of the failed ones do: the committee, not the technology, is the difference-maker. Early and continuous partnership between pathology and IT. Named super users on the bench who become the change champions. A finance seat that understands the number goes up before it comes down. A lab operations lead who can say, honestly, whether the plan is feasible on the floor.
Pathologist
Feels the value first. Rarely signs.
Technology
Has to make the pieces talk, and keep talking after upgrades.
Financial
Needs the whole cost, not the license fee.
Lab operations
Not a decision maker. The feasibility gate.
The labs that got buy-in did it the same way: a team of pathologists and administrators evaluated scanners together, scanned sample slides, circulated them to the pathologists who would read on them, and went to see digital working somewhere else before deciding. The buy-in came from being part of the evaluation, not from being told the outcome.
What one lab CEO told us, five years and two sites into her own transition: if you do not put a team together first, you are going to fail. She had built her own LIS to make digital work. Most labs will not, but the point about the team stands.
1.3 Chain of Custody
Hand-labelled cassettes and slides are the single largest source of misidentification risk in the anatomic pathology workflow. The digital transition point is a case-specific barcode generated by the LIS and printed at the point of use: at grossing, at the microtome, and read again at the scanner so the image files itself against the right case with nothing typed twice.
Frame this as the prerequisite for everything downstream, not a nice-to-have. AI, remote reading and turnaround analytics are only as reliable as the specimen identification chain feeding them.
1.4 Case and Workflow Digitization
Digital accessioning and case assembly, so a complete slide set is confirmed before a case reaches a pathologist. Structured reporting in place of paper requisitions and transcription queues. Dashboards that show block and slide status per grossing session, so exceptions surface automatically instead of being tallied by hand. None of this requires a scanner. All of it makes the scanner worth owning.
1.5 Choosing a Scanner
A small number of whole slide imaging systems hold FDA clearance for primary diagnosis in surgical pathology in the United States, and that fact narrows the field immediately for any lab that needs a clinical rather than research workflow. The right question to ask a vendor is not whether a scanner is cleared but what exactly the cleared configuration is, component by component, and what your lab would be validating on top of it.
Scanning adds a step. Labs that planned for it sized the fleet so slides were still ready for pathologists first thing in the morning, then found the added step was offset by work that disappeared: no more sorting slides by destination every night, special stains read the same day instead of the next. Plan for the step. Then count what it removes.
Throughput figures vary by tissue type, slide quality and site configuration. Treat every vendor number as a starting point for your own validation, not a spec.
| Scanner (Manufacturer) | US Regulatory Status | Throughput / Capacity | Notable Strength | Notable Trade-off |
|---|---|---|---|---|
| Aperio GT450 DX (Leica Biosystems) | FDA 510(k), primary dx (2024) | ~450 slides/hr rated; continuous loading, ~32 sec/slide | Fastest throughput in class; large installed base in North America | Premium price tier; showed highest discordance in some tissue subtypes in comparative studies |
| Aperio AT2 DX (Leica Biosystems) | FDA 510(k), primary dx (2019) | Up to ~400 slides; 20x/40x | Long clinical track record, broad site familiarity | Slowest scan rate among the 6 cleared scanners in independent comparison |
| VENTANA DP 200 / 600 (Roche) | FDA 510(k), primary dx | Vendor-stated mid/high volume | Tight coupling with Roche IHC/special-stain ecosystem | Best positioned for labs already on Roche staining platforms; less advantage otherwise |
| IntelliSite Pathology Solution / UFS (Philips) | FDA cleared 2017 — first scanner cleared for primary dx | Vendor-stated high volume | Broadest validated feature set in some ILR/precision studies | Highest slide rescan rate in one independent clinical comparison |
| NanoZoomer S360MD (Hamamatsu) | FDA 510(k) 2022, supplement 2023 | Up to 360 slides/load; 20x/40x | Strong reputation for image quality and cross-instrument reproducibility | Newer clinical entrant vs. Leica/Philips installed base |
| E1000 Dx (Epredia) | FDA 510(k) (K241717) — newest clearance | Vendor-stated | Newest cleared platform; competitive entry pricing narrative | Shortest track record of the six for long-term clinical performance data |
| Pannoramic 1000 (3DHISTECH) | CE-marked / RUO in US (not FDA-cleared for primary dx) | Auto & semi-auto modes | Strong presence in Europe and research settings | Not usable for US primary diagnosis today |
| NanoZoomer S60/S210/SQ family (Hamamatsu, non-MD) | RUO / education tier | Single-slide up to modest batch | Low footprint, price-accessible entry point | Research/education use only, not clinical |
| TissueScope iQ (Huron), Genius (Hologic), Pramana | RUO / niche clinical use outside US primary-dx pathway | Varies; some support mixed slide sizes in one tray | Niche strengths (mixed slide-size handling, specific specialties) | Smaller installed base; less third-party comparative validation |
1.6 IT Infrastructure Readiness
Whole slide images are among the largest files routinely generated in healthcare. A busy lab can produce tens of terabytes a year, and storage growth is reliably underestimated in early planning. Four gates to clear before go-live: tiered storage for active work and long-term archive, network bandwidth that keeps the viewer from lagging, compute if image analysis is in the plan, and a data-format strategy that keeps you out of long-term lock-in.
Multi-site labs add a fifth: moving very large files across more than one organization’s security protocols, bandwidth and access controls. The labs that did this well spent their time here before a scanner arrived, not after.
1.7 Validation and Compliance
Every component in the chain, from scanner to viewer to LIS interface, needs institutional validation before clinical use, and CAP and CLIA guidance apply to the digital workflow exactly as they apply to the wet bench. Labs decide how digital tools fit their validated procedures. Budget the time for it as a workstream, not a checkbox.
1.8 What It Will Cost
This is a completeness check, not a comparison, and the honest number goes up, not down. If a proposal does not have a line for each of these, the missing lines are yours.
License
In every proposal
Interface and maintenance fees
Usually
Validation labor
Usually
Storage, growing every month you operate
Often missing
The coordinator role nobody planned for
Almost always missing
Training as its own line
Often missing
Be honest about geography too. A multi-site network can justify digital on logistics alone. A single-site lab where histology is across the hall from the pathologist will find the return harder to quantify, and should say so to its own committee before a vendor does.
Part two Optimizing for the Pathologist
Most labs that go digital solve the pathologist’s experience first, and they are right to. It is where the value shows up, and where nearly every lab we have spoken with stalls a year later. This part is about why.
2.1 Value Shows Up at the Pathologist First
Reading from anywhere. Consults in minutes. Coverage across sites without a car. Younger pathologists who expect a workstation, not a microscope. The pathologist’s experience is the visible win, and it is real. It is also not the whole story.
Two things we heard from very different labs. The first, from an academic department: nobody would go back to the better optics of a microscope once all the surrounding support infrastructure exists. The second, from a multi-site network: when one site lost its network connection and glass came back out, the pathologists refused it and asked to be sent somewhere they could keep reading digitally. The word that matters in both is surrounding.
2.2 The Handoff That Never Comes Back
Here is the pattern. The LIS launches the viewer. The pathologist reads. And nothing structured comes back. The system that knows what the case is, who is reading it and whether it is complete is the one the case just left, so the lab is told nothing until the pathologist asks for something.
What that looks like on the floor: a pathologist pinging the bench to ask whether a slide was scanned. A technologist keeping a spreadsheet of what went to the scanner. Someone whose job became watching worklists so cases arrive ready. Quality review with no place to live. A case moved from one monitor to another by picking up a barcode scanner. None of these are software failures. They are what happens when only one end of the workflow went digital.
The pathologist got faster. The lab did not.
2.3 What Optimized Actually Looks Like
The right slide, already open. The case, the history and the report in the same place they always were. A viewer the pathologist trusts, whether it came with the LIS or the lab already owned it. And a case that is complete when it says it is, because the system that runs the case is the one that knows.
See How NovoPath Does It The digital pathology LIS, and what the pathologist’s screen looks like when the slide opens from the case.
Digital Pathology LIS
Part three Extracting the Full Value
Digitizing a lab creates new jobs, and they are jobs for the system of record. This part lists them as questions, so you can ask any vendor, including us, and take the answers to your committee.
3.1 There is More to the Story
3.2 The Nine Questions to Ask a Vendor
Ask what happens to the case, not what happens to the image. Write the answers down. Then ask the next vendor the same nine.
How Does the Lab Know a Case is Complete Before a Pathologist Opens It?
Slides expected, slides scanned, slides missing. Who is told, and where.
How Are Digital Cases Assigned, and Can the Rules See Glass and Digital Together?
Subspecialty, client, workload and location, in one worklist.
Can a Case Be Routed to Glass or to a Screen, Per Case, Indefinitely?
Coexistence is an architecture, not a transition phase. Ask how long it is supported.
What Decides Which Slides Get Scanned?
Payer, ordering clinician, pathologist preference, test type. Who sets the rule and where does it live.
Does the Scanner Read the Barcode the LIS Printed?
If the image is found by file name rather than by case, someone is retyping.
Can a Lab Lead See Where Every Slide is Right Now Without Asking Anyone?
Queue state, by site, by scanner, by pathologist.
Who is Told When a Scan Fails, and When?
Before the pathologist opens an empty case, or after.
Where Does the Delay Show Up?
Turnaround by step, not by case. If the answer is a monthly report, the answer is no.
Where Does an AI Result End Up?
On the case, in the report, or in a viewer nobody reconciles. Orphaned results are the most expensive kind.
3.3 Take It to Your Committee
Part four Where NovoPath Fits
Everything before this line was written to be useful whether or not you ever talk to us. This part is the exception, and it is labelled so you can skip it.
The vendor section Clearly labelled. Skip it if you like.
NovoPath is a cloud-native anatomic pathology laboratory information system used by more than 300 laboratories. It is the all-in-one LIS that takes your pathologists and your lab fully digital. It includes a viewer, and it connects to the scanners and viewers a laboratory already owns, so nothing has to be replaced to start.
For your pathologists
For your lab
For your business
Also on this page
Common Questions
What is Digital Pathology?
Digital pathology is scanning glass slides into whole slide images and managing, viewing and reporting on them through software. For a laboratory it is an operational change as much as a technology one: the case, the slide and the report have to stay connected as the slide moves from glass to screen. Part One covers the operational side.
Is Digital Pathology FDA Approved?
FDA clears specific devices, not digital pathology as a whole. Scanners and software used to view whole slide images for primary diagnosis need FDA clearance. Laboratory information system functions, including ordering, tracking, case management and displaying images and results alongside the case, are not regulated as a medical device. Laboratories decide how digital tools fit their validated procedures under CLIA and CAP. See 1.7 and the regulatory note.
What Features Should Digital Pathology Software Include?
For the pathologist: the right slide opening from the case, with worklist, history and report in one place. For the lab: barcode chain of custody from accessioning to scan, case assignment, role-based worklists, discrepancy checks and prebuilt connections to scanners, image systems and EHRs. For the business: one accountable vendor and reporting that sees the whole case. The nine questions turn this into a checklist.
How Can Digital Pathology Improve Laboratory Workflows?
Only when the workflow is digital, not just the reading. Barcoding removes handwriting from cassettes and slides. Case assignment removes morning triage. Worklists show what is ready and what is waiting. Reporting sees every step because every step happened in one system. A lab that digitizes only the pathologist’s screen usually finds the lab’s work did not change. 2.2 describes what that looks like.
The All-In-One LIS That Takes Your Pathologists and Your Lab Fully Digital.
Two minutes is all the demo needs. See NovoPath at PathVisions 2026, Booth 406, October 16 to 18, or talk to us before then.
Regulatory note
Regulatory note. NovoPath’s laboratory information system functions, including ordering, accessioning, specimen tracking, case management, reporting and displaying images and results alongside the case, are not regulated as a medical device under the 21st Century Cures Act. NovoPath’s whole slide image viewer is not FDA cleared for primary diagnosis. Laboratories decide how digital tools fit their validated procedures under CLIA and CAP.