Podcast Transcript

Anjli Venkateswaran: I am Anjli Venkateswaran, Senior Director of Marketing at Biomere, and it is my pleasure to introduce Tom Schofield, who will be joining me today. Tom is the founder and CEO of Splice Histology, a startup offering preclinical and clinical histology services. Biomere has recently partnered with Splice to offer histology and IHC analysis on samples dosed with novel therapeutics.

Prior to founding Splice, Tom had over 20 years of experience in the anatomic pathology and histology space, holding positions at Quest Diagnostics, Beth Israel Lahey Health, and LabCorp. Biomere is a preclinical CRO with locations in Worcester, Massachusetts, Richmond, California, and multiple sites in China. Our portfolio includes comprehensive PK, PD, and toxicology services, and you can learn more about Biomere’s service offerings at www.biomere.com.

Without further delay, let’s get into today’s topic on this exciting partnership focused on preclinical histology services. Welcome, Tom. I’m so glad you could join me today. Let’s start with an overview of your journey to founding Splice, because you’ve built a long track record in this space. What were the driving forces to start your own company?

Tom Schofield: Hi Anjli, thanks for having me. It’s great to be here. The best way to explain why Splice started was that prior to Splice, I was a director of pathology for a large international company. We saw a trend coming out of the pandemic where there was a severe lack of histotechnologists. You didn’t see the problem as much during the pandemic because there weren’t as many biopsies to process.

Then, around March of 2023, COVID testing went away in a matter of weeks, and I started receiving calls from hospitals across the country saying, “I don’t have enough histotechs. Can I send my tissue blocks to you to simply cut them, make a beautiful H&E, and return the slides and blocks?” We were turning away up to 10,000 blocks a day.

When you look into it deeper, it’s one of the few laboratories that is still manual; there’s not a whole lot of automation. There are so many factors that go into making a beautiful histology slide, and the number of schools that have a program continues to dwindle. I think there are only about 26 left across the entire country.

Anjli Venkateswaran: Wow, really? Why is that?

Tom Schofield: I think it’s a lack of awareness of the profession. The average age in the field was in the mid-to-upper 50s. I spoke at a conference last year to explain what Splice does, because in addition to doing histology, we also have a histotech training program. To bring awareness, I asked the audience of 90 people to raise their hand if they were under the age of 30. Only one person raised their hand.

I spend a good amount of time talking with local schools, even high schools, sharing the message of what histotechnology is. Certainly, when I talk about the compensation—for an associate’s level degree, it’s quite good. For folks who want to play an important role in healthcare but not deal directly with patients, this is a perfect place behind the scenes.

Because we were turning away so many blocks per day, I said we need to do something about this problem. We needed to build an operation that could support places needing this service. Some hospitals were four to six weeks behind, and these are all patients waiting for an answer. Internally, we need the right systems to manage and document quality. It’s all about quality for us.

Anjli Venkateswaran: Right. To be clear, that is the data being used to make patient treatment decisions. It’s critical that the quality is consistent and top-notch.

Tom Schofield: Exactly. Even basic things, like putting the right piece of tissue onto the right slide, require internal mechanisms and systems to ensure accuracy. The company I worked for didn’t really want to build capacity, so I stepped away and started Splice at the very end of 2023. We’re located in Worcester, Massachusetts, right down the street from your offices.

When we began work about six months later, we found ourselves where we are today. We are about two years old, and we have about 150 hospitals that have access to use us. It’s interesting how we started and where we are now. The biggest thing we realized was that the problem isn’t just histotechnologists in hospitals; the field has expanded way beyond clinical. We are now heavily involved in research and drug development.

Anjli Venkateswaran: It’s interesting because histotechnology is one of those “AI-trust” professions. In my mind, I view it as an art. It is a science, but there is an art to it. There is a lot of human judgment involved in grossing, fixing, and embedding these tissues. Some tissues are more robust than others, and that huge art component makes it a very human profession.

Tom Schofield: You’re absolutely right. Proper fixation, fixation time, tissue processing, and orientation during embedding are all things that vary based on the sample. Even the humidity in the room or vents can affect the tissue ribbon. While some companies have tried to automate it, I think we’re still 5 to 10 years away from a machine reproducing what a human can do.

Anjli Venkateswaran: I would hazard a guess that while robust tissues could be automated, I would hesitate with soft tissues or something like the eye. Ocular tissue is tricky; there’s hard tissue, soft tissue, gel, and matrices. Having been in this space for over two decades, I find histopath analysis so informative. You can actually see the tissue architecture changes or damage. It speaks much louder than just a number. High-quality histotech data is priceless.

Tom Schofield: I can give you an example. We never intended to get into research until we started getting calls from pharma and development companies. I worked with a company that had purchased blocks from a failed clinical trial—about a thousand blocks. We determined that about a third of those cases were not embedded in the right orientation. They should have excluded a significant portion of those patients from the trial, which would have dramatically impacted the results.

Anjli Venkateswaran: That shakes me, because that is entirely avoidable with the right training and processes. It’s not a biology issue; it’s a process-driven issue.

Splice started as a clinical service for hospitals, but you’ve pivoted to pre-clinical services. When the Biomere team met you, we realized it’s tough to find providers in the preclinical space who hit all the checkboxes: consistent quality, expertise across different tissues, consistent pricing, and timelines. The clock is ticking in preclinical research because you have to make quick decisions on animal models. Was that pivot just happenstance?

Tom Schofield: The phones kept ringing. Part of the DNA of Splice is that we’re amazingly human. I’m typically involved in these customer calls and in the laboratory quite a bit. We started with a veterinary client, which got us into non-clinical work. Then we realized we needed to bring in someone who speaks the research language as a consultant. That’s why we brought in Bruce to work with researchers and nail down projects quickly.

Anjli Venkateswaran: That’s very true. In pre-clinical discovery, it’s very open-ended. You have to go where the data takes you. If you have an unexpected finding, you have to pivot on a dime.

I also wanted to ask about reagents. With human samples, there are many validated antibodies available. But with non-human species like mice, rats, or primates, it can be tricky. Has that been a rate-limiting step for Splice?

Tom Schofield: We have great automation for immunohistochemistry (IHC) and immunofluorescence (IF). We have an instrument that allows for assay development. We can develop assays that don’t necessarily mirror our clinical offerings.

Anjli Venkateswaran: Tell me more about automation. I saw some really cool instruments in your lab. Automation reduces human error and speeds things up. What have been your favorite “toys” to implement?

Tom Schofield: There are a lot. Many of our customers are startups and don’t have the capital to spend $200,000 on equipment, so we bring that in for them. The first one that was really fun was brightfield scanning. We brought in an automated digital scanner that scans up to 40x. Unlike other labs where it’s integrated into one LIMS system, we push that data into three different image management systems depending on what the client prefers.

Today, we use platforms like Lyra and Proscia, or we can simply download to a manual hard drive. Another fun project was the digital scanner. Because we started receiving over a thousand blocks a day, we added automated H&E stainers—the Sakura Prisma. We have two now: one for clinical and one for non-clinical. We also got a BioCare ONCORE Pro for IHC. We like this platform because it handles several methodologies—IHC, ISH, and IF—all in the same instrument. It allows us to get more out of expensive reagents, which is vital for multiplex spatial biology.

Anjli Venkateswaran: If a preclinical client has a new biomarker but no IHC assay, is that something Splice handles? Can you develop the protocol from scratch?

Tom Schofield: Yes, that’s where our consultative approach is important. Some clients want to try their own antibodies, or they want us to source them. A crucial part of this is the control tissue. We have partners with access to tens of thousands of tissue blocks with pathology data. Finding the right control is key to identifying the signal and avoiding artifacts.

Anjli Venkateswaran: You also have an amazing team. These are experienced, top-notch people. Tell me about your staffing.

Tom Schofield: We have a core team. Our laboratory manager is incredible; she understands the histology process so well she can look at a slide and tell you exactly what happened during fixation or processing. She trains all of us.

The rest of the team is very resilient. We work 24/7 when needed. We have a new customer in Pennsylvania sending a couple of hundred blocks tonight, so the team will be in tomorrow on a Saturday. That’s the life of a startup—you need people who believe in the company and are willing to work around the clock until the volume becomes predictable.

Anjli Venkateswaran: That deserves a moment of applause. Histopath has a ticking clock, and your “can-do” attitude—getting things done without sacrificing a millimeter of quality—really sets Splice apart.

Tom Schofield: Thank you. One other comment: we do a lot of hospital-based work, but the research side is incredible. For researchers, this project is their whole life. Partnering with Biomere to get histology as their endpoint is a huge part of our CRO growth.

Anjli Venkateswaran: Exactly. Clients come to Biomere and Splice to make “Go/No-Go” decisions on new drugs. If they see massive cell damage in a histopath analysis, they need that info immediately. In drug development, time is money, and patients are waiting.

To wrap up, let’s talk about data analysis. Pathologists can read a slide like an encyclopedia, but the average scientist might not. What is Splice’s approach to analyzing this data?

Tom Schofield: Partnerships are key here. We are focused on creating the data; we aren’t an AI company. But you have to start with a beautiful H&E. Without a clear image, scanning and AI analysis are irrelevant. We focus on brightfield and thermal scanning and then push that data to partners.

Anjli Venkateswaran: I agree. People get carried away with AI, but if the starting image is fuzzy, you’ll never get meaningful data.

Tom Schofield: Exactly. It starts with fixation and embedding. Even cover-slipping can introduce air bubbles. We use automated QC on our scanners to check for focus and tissue folds. You need a beautiful slide to get a beautiful scan.

Regarding IHC, we can do single-plex or multiplex. We’ve done a six-plex PD-L1 panel on a single slide, which is important when tissue is limited. For fluorescent multiplex scans, we use a local partner’s specialized scanner. Once a slide is cover-slipped, it’s very transportable, as long as you keep fluorescent labels out of the light to avoid bleaching.

Anjli Venkateswaran: And what about the pathology reports?

Tom Schofield: On the clinical side, we are a CAP-accredited lab with a clinical director. However, creating an H&E is considered a service, not a “test” by CLIA standards. On the research side, we brought on a veterinary pathologist who works with us on a per diem basis. He joins initial discussions to develop the statement of work and performs the vet path analysis for small animal studies.

Anjli Venkateswaran: That completes the workflow. Biomere handles  in vivo studies, you handle the histology, and the vet pathologist closes the loop with a report. So, what are the plans for growing Splice?

Tom Schofield: We began investing in contract research (CRO) last summer. We spent the last six months getting the word out, visiting places, and going to meetups. In January, we really started to see growth. I’d like to see research make up 50% of our business; right now, it’s about 20%.

On the hospital side, we are moving toward a subscription model. We just sold our first subscription to one of the largest health systems in the country, covering over 40 hospitals. These are large sites processing 2,000 to 3,000 blocks a day. They will always have this need, so subscribing to Splice makes sense for them. Growing consistent, predictable revenue is our top priority.

Anjli Venkateswaran: We’re so excited to offer our clients these expanded services in partnership with Splice. Thank you, Tom, for joining me and for sharing your vision and sharing, so much great information on splices, capabilities. I’ll say to our listeners – if you’re interested in learning more about our services online, check out biomere.com, or you can email us at bd@biomere.com and check out Splice and Biomere’s LinkedIn pages.  We’re so proud to have announced this partnership in January and we’re looking forward to an exciting collaboration, not just for client projects, but also for some really interesting internal research projects, which I hope can be presented as posters and papers.