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How X-Zell's founder and CEO Dr Sebastian Bhakdi achieved same-day cancer diagnostics

Dr Sebastian Bhakdi, founder and CEO of X-Zell
Dr Sebastian Bhakdi, founder and CEO of X-Zell

Cancer diagnostics can require more than 48 hours, which means agonising waits for patients and crucial time lost for clinicians. The bottleneck lies in the lab, where technicians must first process patients’ cell samples with a tedious multi-step workflow before a pathologist can analyse them. This may soon be a thing of the past though, as Singapore-based startup X-Zell has introduced a new technology that produces results in just 4 hours.


X-Zell’s Cryoimmunostaining platform – named for its sub-zero operating temperatures – fundamentally reworks the process by skipping or consolidating various steps in the original workflow. The company’s proprietary hybrid microscope further streamlines things by digitising processed samples for same-day cancer diagnostics. This is akin to the leap from film photography to digital photography. Founder and CEO Dr Sebastian Bhakdi describes this as “a win-win-win situation”: doctors can conduct more timely interventions, patients are spared the agony of waiting, and laboratories benefit from greater efficiency.


X-Zell scientists conducting cryoimmunostaining
X-Zell’s two-stage Cryoimmunostaining suite in action

A vision some 10 years in the making, X-Zell’s system has made much progress in the last 12 months, including the conclusion of product development for the first-generation Cryoimmunostaining suite in 2022. In June this year, the company also announced the first adoption of its system into routine diagnostics by Germany-based MVZ Frankfurt, a regional pathology/diagnostics centre.


X-Zell has, at this point, already proven its system’s viability and moved into the early phases of revenue generation, with reimbursement codes also in place for some markets. This puts it on the cusp of explosive growth in the following 24 months, all while further developments continue to take place. Dr Bhakdi shares more in the following interview.


X-Zell has achieved several important milestones in the past few months. Where are you right now with regard to your technology and its adoption?

Currently, our platform helps pathology labs to analyse minimally invasive body liquid samples for cancer diagnostics in under 4 hours. This system has already gone into routine [i.e. adopted for routine diagnostics] at MVZ Frankfurt in central Germany, an important medical centre specialising in pathology, cytodiagnostics and molecular pathology.

The ability to process fine-needle biopsy samples is next. This will enable wider applications to what we are doing now, because you can get a sample from almost any part of the body with a fine-needle biopsy, which opens many technical possibilities. As this method is minimally invasive too, we think we can really give this area a push by providing improved readouts with our system. We are already exploring collaborations to bring this function into our platform.

The third stage is the holy grail, and that’s liquid biopsy from blood samples for cancer screening. We are still running clinical studies on this in Singapore.


Your system follows the same principles for diagnostics as the current immunohistostaining standard, but speeds things up by reworking the entire lab process and bringing it on a digital screen. Was there ever a point during R&D when you knew that this would work?

Yes, and that was relatively recent. I’ve always thought that our system’s multiplexing feature – the ability to apply multiple antibody stains to a single microscope slide – offers fast and reproducible results with strong visuals, which should make it well-suited for routine diagnostics. But nobody was actually multiplexing in routine diagnostics to this extent. Having 2 to 3 different stains on a slide? Maybe. Definitely not 8 though. When I first showed what we had developed to [German pathologist] Dr Achim Battmann, however, he loved what he saw. This was what made me confident that the multiplexing feature would work.


Scientist studying antibody stain with X-Zell system
X-Zell’s system enables multiplexing with up to 8 different stains being applied to a single slide, maximising the data obtained from every sample

But Dr Battmann still had concerns about our platform’s speed and usability. He showed me how his workload only gave him around 30 seconds to look at each slide, with an average of slides for every case he had to diagnose. We agreed that if X-Zell could let him screen a case in under 2 minutes with fewer than 3 mouse clicks, he would adopt our system. So we developed the system towards these goals. It’s taken around a year, but Dr Battmann is now moving into routine with our system at MVZ Frankfurt.


A year’s development doesn’t actually sound too bad.

Not in terms of solving a problem, but we had to identify the issue with the workflow before we could tackle it. Now that it’s done, laboratories and their technicians will save a lot of resources, while pathologists will have an easier time and can probably make better diagnoses. It’s a win-win-win situation. Of course, since we now know what pathologists want, both from the immunostaining process and the user interface, things should move much more quickly.


What are your immediate priorities?

For many medical device companies, FDA clearance is a major hurdle to clear. For us, however, it’s a fairly straightforward registration, which we will be ready for by the end of this year.

What’s really the most pressing priority right now is finding more innovative pathologists and getting our platform into as many KOL [key opinion leader] labs as possible. It's actually more difficult to track them down than to onboard them. There aren’t that many pathologists, relatively speaking, and they’re always hiding behind their microscopes. (laughs) If we can get the buy-in of a few large pathology labs in the US, that will lend our platform a lot of gravity. I will be spending most of the remaining year in the US to do this.


X-Zell cytoblocking slicing wax blocks
A major time sink that X-Zell has eliminated is cytoblocking, where cells are affixed in wax blocks that are then sliced and mounted onto slides

Cytopathology’s principles and processes are very technical. How have you managed to secure investments so far, given how challenging it can be to explain X-Zell’s technology?

It hasn’t been easy. Our investors have mostly been angel investors, not institutions, and the ones who have signed the larger cheques are all successful entrepreneurs from our immediate personal networks, especially contacts of our COO [Johannes Hille]. They know that cancer is a major problem and that we are working on its diagnostics, and they trust us to figure out the solution. A lot of our funding is based on preexisting relationships, and our investors’ trust in the team.


What will you say to potential investors who are considering an investment into X-Zell?

I think it’s important to know that our roadmap has never been clearer, thanks to the recent addition of [former Roche Diagnostics North America and Asia Pacific CEO] Michael Tillmann to our board. Through him, we have connected to many industry leaders and gained a lot of confidence in our exit strategy. What we’ve learned is that we don’t need huge business traction to get on the radar of the industry leaders. Instead, we must get our Cryoimmunostaining platform into KOL laboratories and demonstrate clinical value in these labs, as they lead the conversation in this niche industry..

Once we get into 5 to 10 such labs in Europe – Germany especially – and the 3-4 major centres in the US, we will be on the radar for a strategic acquisition by a major player. That’s what we are going to do, followed by an exit in the next two to three years. And when that happens, we will give our investors nice returns anywhere between 4x to 10x, conservatively speaking.


X-Zell closing image

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