Groundbreaking Steps in Melanoma Monitoring with Digital PCR Tests: Dr. Claudia Scheckel, Oncobit

Dr. Claudia Scheckel, Oncobit: 0:00

We're trying to give the patient and the physician of course as well more information on the patient's cancer.

Alex, X-Health.show: 0:10

Hi, I'm Alex and welcome to the X-Health. show, where I talk to visionaries behind the latest innovations in healthcare. For the eXtra health of the future. We're just outside of Zurich, Switzerland, in Schlieren, where billions of pieces of DNA are amplified in a lab next door. My guest today is Dr Claudia Scheckel, a CEO of Oncobit, a biochemist that worked for almost a decade in biomedical research at the Rockefeller University in New York and University Hospital Zurich, Switzerland. Oncobit is a Swiss startup developing precision monitoring assays for personalized cancer care. Their platform provides a rapid quantification of circulating melanoma tumor DNA and hence supports patients and doctors in adjusting for the optimal treatment. You'll hear about skin cancer, melanoma markers, PCR tests for melanoma stages, the difference between PCR and digital PCR, and an agile startup in a slow moving hospital environment. Claudia, this summer, the Netherlands offered free sunscreen to protect people from skin cancer. Where would you recommend a similar solution to be introduced?

Dr. Claudia Scheckel, Oncobit: 1:23

The Netherlands is definitely amongst the top countries with a high incidence of skin cancer or also melanoma, but Switzerland is amongst the top 10. So when you go around in the city now in summer, right, everyone is enjoying the sun – if you work with a topic like that, you start to be a little bit more aware of the dangers of UV. Switzerland is amongst the top 10, as, of course, Australia, New Zealand, the Nordics, Germany. In those countries it would definitely make sense that people start to use sunscreen more, or use it even more as they do already now.

Alex, X-Health.show: 1:59

So you're basically worried for people who are enjoying the sun and turning golden brown.

Dr. Claudia Scheckel, Oncobit: 2:08

I mean I myself I've changed the more I've worked on this topic. Of course, like I already said, you're more sensitized to that. It's not healthy. I think there was this conception decades ago that being outside and having a base tan was something healthy. But now we know better. Now we know that sun exposure is really bad and it increases skin cancer rates, and it's something that actually can be easily prevented.

Alex, X-Health.show: 2:55

Let's go down a bit to how can we discover that we might have a skin cancer. So how does the current skin cancer or melanoma diagnosis and monitoring look like? We can have a mole and should we go to the doctor?

Dr. Claudia Scheckel, Oncobit: 3:14

Yeah, that's actually the good news when it comes to skin cancer. So let's maybe also clarify – melanoma is one type of skin cancer. It's actually only 5% of the skin cancer cases, but it's by far the deadliest. So while only 5% of skin cancer cases are melanoma cases, 75% of the skin cancer related deaths are melanoma. So it's very deadly, but at the same time, we have the chance, because it's a skin cancer, typically it can be easily recognized through early diagnosis.

Dr. Claudia Scheckel, Oncobit: 3:47

S kin cancer screening is something that everyone should be doing once a year. Alex, X-Health. show" And what's the screen? The screen, oh, it's basically visual inspection of your skin. So about 20 to 30% of melanomas arise from moles, but it's not only moles, so it can also be other other areas of the skin that can lead to melanoma. So once you've been diagnosed with melanoma, so then it really depends on the thickness of the lesion, so which stage you are, and then if the melanoma is still very localized and hasn't spread through the body, then, for example, you also have a very, very high chance of after removal, essentially that you're done with that, that you never have to worry about it again. So the earlier the better. Exactly, and that's why this early detection, these skin cancer screenings, are so important.

Alex, X-Health.show: 4:37

Who should be doing that? I mean, is it enough that I do it by myself, or is it better by a doctor? A GP or dermatologist?

Dr. Claudia Scheckel, Oncobit: 4:46

dermatologist. I think everyone can also have a look at something that maybe changes color, shape – that's usually the early warning signs. But I myself would rather have a dermatologist look at that.

Alex, X-Health.show: 5:04

So the diagnosis is the dermatologist and what happens when you are actually diagnosed with melanoma?

Dr. Claudia Scheckel, Oncobit: 5:14

Then it depends a little bit on the stage. So the further progressed you are, the more so. For example, in the in the earlier stages, as I said, the melanoma is really localized to a very focal point on your skin. Once it spreads then, for example, initially to the, to the lymph nodes, the ones that are adjacent to that site, and then, in the worst case, you've had spread of metastasis to distant sides of the body, ultimately even the brain. And depending on which stage you are, different tests are being performed. Actually it also depends on the country. So every melanoma is very different, every cancer is very different and there are different markers, and these markers have an impact on which therapies you can get, and also how you respond to therapy. So depending on the stage, you are being tested for these markers.

Alex, X-Health.show: 6:06

Let's speak about, we are at this stage when it is... How do we know it's the first stage, actually? It is on the skin, how can we check it's not somewhere else?

Dr. Claudia Scheckel, Oncobit: 6:19

It depends on the thickness. So the staging is done depending on the thickness of the mole or the lesion and the thicker it is, the more likely it would have spread. And so when there is a chance that it might have spread, the adjacent lymph nodes, for example, are being looked at, and if those are positive then one looks further. But one really starts initially with the primary tumor and based on the staging of that one decides then how to progress.

Alex, X-Health.show: 6:51

And then we progress with general cancer markers? Do we do blood tests or some other screening?

Dr. Claudia Scheckel, Oncobit: 6:59

So that's another positive thing about melanoma is that you typically have the primary tumor. That's something that is not always the case. Let's say, for example, if you have lung cancer, it's much more difficult to get the tumor or even to detect it. With melanoma, there is typically a tumor tissue available that can be tested, and so I already mentioned that there are certain markers that make you then eligible for certain therapies, and so that's why it's then important to test for initially specific markers, but then besides these very specific markers, for melanoma for example, one very, very important is BRAF, and if the patient has this marker BRAF-E600, then the patient is eligible for certain therapies. Alex, X-Health. show: What is this marker? Dr. Claudia Scheckel, Oncobit: It's a DNA mutation, so it's an alteration that patients acquire, for example, through environmental influences.

Alex, X-Health.show: 7:53

UV light in this case, or something else, because we are not 100% sure what's behind it. So is it blood tests, then any other screening?

Dr. Claudia Scheckel, Oncobit: 8:04

Then, as I said, it depends a little bit on the stage. So, for example, if the cancer has already spread, typically sequencing tests are used. So what sequencing does? It not just looks for specific markers, but you can look at many, many, many different markers at the same time. And this more comprehensive characterization of the DNA markers then allows the physicians to choose certain therapies. It just gives you additional knowledge on the patient's cancer, and that's typically done for patients that are 3, stage 4. This is now, in the larger hospitals at least, this is relatively routinely done that you use such a sequencing test.

Alex, X-Health.show: 8:47

And what are they based on? What part of body, basically, I wanted to ask.

Dr. Claudia Scheckel, Oncobit: 8:54

I mean melanomas, can really...

Alex, X-Health.show: 8:56

It's the same tissue we speak about? Dr. Claudia Scheckel, Oncobit: Yeah, yeah, it's the same. So on the initial primary tumor.

Alex, X-Health.show: 9:03

So that's a lot we can actually test on this one tissue. And then, yeah, I think we are ready now to ask about Oncobit solution. Yeah, what happens when you enter? What is your solution? How can you help, I don't know, diagnose it or monitor it better?

Dr. Claudia Scheckel, Oncobit: 9:42

For melanoma at the moment, the way that the patient is monitored is really with imaging or with blood marker tests, and these blood marker tests right now that are in use are quite unspecific and also not very sensitive. Unspecific I mean they are, for example, detecting inflammation, and of course, inflammation can have all kinds of different reasons. It can be linked to cancer but it can also be linked to you having a cold. So they're not very specific. They might be positive because of the melanoma but they might also be positive because of something else and at the same time they are not very sensitive. They are protein-based – maybe this is going a little bit too much into detail, but you can only detect a certain threshold, and if it's below that threshold you won't detect it.

Dr. Claudia Scheckel, Oncobit: 10:33

And then the second and that's actually really the gold standard when you talk about melanoma monitoring is scans. In Switzerland it's predominantly PET CT scans, and that means that the patient has to lie still for quite some time in a tube, but also the patient has to swallow radiation and this dose is really quite strong – afterwards, for example, the person should not ride in an elevator with a kid. These scans are performed at the moment in regular intervals and, depending on where you are in your monitoring routine, it could be even every three months. So they're performed quite often. They are, on one hand, very powerful because they not only allow you to diagnose, or to detect, cancer, but also to localize it. So it's a full body scan and that means we know exactly where in the body the patient might have metastasis, where the cancer has spread.

Alex, X-Health.show: 11:28

The radiation helps detect it but then again you also are radiating.

Dr. Claudia Scheckel, Oncobit: 11:34

Right. You're labeling essentially cells that have high metabolic activity and that's what you can then detect, and that's typically cancer cells.

Alex, X-Health.show: 11:43

It is thorough though right? You can find really specific locations of cancer.

Dr. Claudia Scheckel, Oncobit: 11:53

Well, yes, so you can find them anywhere in the body but they need to have a certain size, so they need to actually be one centimeter in diameter to be detectable. And then also, what I just mentioned, metabolically active cells are lighting uP on the scan. Cancer cells are often metabolically active, They divide often. But it could also be that something else is going on in your body that has nothing to do with cancer but that is just very metabolically active right now. Alex, X-Health. show: What would that be? Dr. Claudia Scheckel, Oncobit: I just heard, for example, when talking to physicians, that COVID vaccination led to higher metabolic activity. Just to give you an example. There would look like a false positive scan. False positive, I mean it's positive for metabolic activity, right, but it wasn't positive for metastasis or cancer in this case.

Alex, X-Health.show: 12:47

So this is what's happening now, and then you have Oncobit solution. What do you propose in place of that, or adding to that?

Dr. Claudia Scheckel, Oncobit: 12:59

We definitely want to add to that. We have developed a test that is minimally invasive, it's used again on the blood like these unspecific markers, but in our case it's very specific. We really detect one specific marker that we know the patient has. I already mentioned this BRAF E600 marker and 50% of the melanoma patients have that marker. We know that if a patient has this marker because that is really tested very, very early on in the diagnosis. Since we now know patient X has this marker, we can follow the patient with our minimally invasive test in quite regular intervals because it's just a blood draw. We just need one tube of blood, 10 milliliters, and in this blood we can then look for this marker and we use a technology that's called digital PCR. So I think we've heard, probably through the COVID pandemic, about PCR, right...

Alex, X-Health.show: 13:55

So I mean it doesn't hurt if you actually explain that.

Dr. Claudia Scheckel, Oncobit: 14:06

With PCR, what you do is you essentially just amplify a piece of DNA. Because DNA is, of course, tiny, with this amplification you can actually visualize it. Typically, you work with something that fluoresces, so that glows green in certain wavelengths, and this allows you to detect even tiny amounts of DNA because you now go through these amplification cycles and you just generate much, much more of this DNA. So instead of having just one piece of DNA afterwards, you have billions. And that's what you can then visualize.

Alex, X-Health.show: 14:40

And you don't need this one centimeter of a cancer in your body. You need some pieces of DNA in your blood.

Dr. Claudia Scheckel, Oncobit: 14:50

Right. So I mean, this one centimeter is the tumor, right.

Alex, X-Health.show: 14:53

Yeah.

Dr. Claudia Scheckel, Oncobit: 14:55

So, to be fair, so what happens when the cancer spreads through the body is that the cancer cells release their cancer DNA into the bloodstream, and that principle is what we are using. We are detecting the cancer DNA or rather these cancer markers in the bloodstream with ultra sensitive technologies like PCR, and actually not PCR, but digital PCR. Alex, X-Health. show: What's the difference? Dr. Claudia Scheckel, Oncobit: PCR we really just measure once. So we amplify the DNA once and measure if it's there or how much of it is there.

Alex, X-Health.show: 15:31

Is it like wet lab techniques to amplify it?

Dr. Claudia Scheckel, Oncobit: 15:34

Yeah. And with digital PCR the big difference is that you parallelize the reaction. So instead of measuring once, we now measure 20,000 times.

Dr. Claudia Scheckel, Oncobit: 15:42

And so we partition that initial PCR into 20,000 little partitions, and within each partition we measure is the DNA there or not? And so now you get actually an absolute quantification of the DNA pieces. Alex, X-Health. show" So is it about possibilities? Well, you Well, not so much possibilities. So you, let's say, you start off with 10 pieces of tumor DNA, of cancer DNA, and you put them into these partitions, these 20,000 partitions, and then each of these partitions is then each mini PCR chamber, and then afterwards you basically count how many of these partitions are now glowing green. And let's say there is 10 now. Then you know that you had initially 10 pieces of tumor DNA in your blood. And so that's an absolute quantification, right? Because we can really count the number of pieces of DNA that we've seen. And that is something that is not possible with regular PCR. So it's more quantitative, it's more sensitive and that's, of course, critical when you monitor.

Alex, X-Health.show: 16:51

Let me just ask, so you get part of DNA and you're rebuilding the whole DNA from this part?

Dr. Claudia Scheckel, Oncobit: 16:58

No, we're really just focusing on that one marker that we know the patient has. So it's more like searching for a needle in a haystack. We know in this haystack we expect 10 needles and those 10 needles are the cancer DNA right. But we know what kind of the needle we have to look for and that's what we do.

Alex, X-Health.show: 17:21

OK, so this is Oncobit PM, so personalized monitoring platform. Now, who is this solution for? Is it for labs? Is it for doctors' offices? For cancer clinics?

Dr. Claudia Scheckel, Oncobit: 17:35

At the moment, the test is really aimed towards patients that have late stage melanoma, so the cancer has already spread.

Dr. Claudia Scheckel, Oncobit: 17:44

The more the cancer has spread, the easier it is to detect the cancer DNA in the blood, and so these patients are typically seen at large hospitals that really are specializing on these later stage melanoma patients, and so that also means that it's relatively few hospitals where these patients that we have to really approach. And those hospitals also, for example, have large pathologies, and that also means they have a certain infrastructure, which they, of course, want to use. That was something that was really important to us that we wanted to develop a solution that could be easily implemented at hospitals. So our tests, it's a platform technology, and maybe we can go a little bit more into detail in that regard later, it consists of tests and also software, and the tests and the software run together with existing infrastructure at the hospitals. With our solutions, we really also want to enable hospitals to perform the test themselves, that's how they also get the results quicker, if they can just run the test themselves and then make decisions based on that more quickly.

Alex, X-Health.show: 18:50

If we have anyone working at such hospitals listening to us now, could you name the technology that they use?

Dr. Claudia Scheckel, Oncobit: 18:58

At the moment the test runs on the digital PCR platform technology of Bio-Rad.

Alex, X-Health.show: 19:12

I can see that when you are speaking about the hospitals and clinics, you might have in mind the clinical studies that Oncobit performed. Could you tell a bit more about the clinical studies?

Dr. Claudia Scheckel, Oncobit: 19:26

So far we've mostly worked with retrospective samples, so that means the samples were already collected, and so we were able to test both stage three and stage four patients. We published this last year, tumor DNA detection was a predictor of disease progression, and that also we saw a nice correlation with other tumor markers that were measured in the blood. The problem with retrospective studies is that you're always a little bit limited to what samples are there and what data is there, and so right now we're running some additional prospective studies, in combination with the University Hospital of Zurich, but also with other leading cancer centers in Europe. Actually we're also starting now with some hospitals in the US to really get a more detailed understanding of when and how it makes most sense to use our test.

Alex, X-Health.show: 20:19

And so what do clinics benefit? And the next question would be how do patients benefit from using this technology?

Dr. Claudia Scheckel, Oncobit: 20:28

So with our technology, our idea is really to sort of give physicians and therefore ultimately, of course, patients like another data point on how their cancer is progressing essentially or not progressing ideally. So at the moment, let's say, they get these scans, but what if we could add something even more specific, right? So it's sometimes very difficult to also interpret these scans. And what if we have something that is where we really can measure something in the blood and at that knowledge At the same time it can be performed much more often, for example, than a scan, right? Because it's just a blood draw.

Dr. Claudia Scheckel, Oncobit: 21:31

And because our tests are quite cost- and time- efficient, so they can be performed in regular intervals more often than a scan, it would maybe make sense in the long run to add an additional blood draw in between the scans to really make sure that one detects cancer recurrence as early as possible. And so that, of course, gives the patients and the physicians more certainty, right, that they're on the right track on how to treat a patient.

Alex, X-Health.show: 21:58

What frequency are we speaking now? We already said that the scan can be done every three months. And what are you testing? The blood draw – how often do you test it now?

Dr. Claudia Scheckel, Oncobit: 22:12

It depends a little bit on the treatment and also the treatment regimen because some treatments, for example, are given every week and often of those patients every week a blood sample is drawn. So depending on the treatment that the patient gets, we sometimes even look every week. For other treatments it's every month or every three to six weeks. So then, right now in these studies we're looking at exactly that time of when they get their treatments. I could imagine that maybe depending on where the patient is in the patient history, so let's say, to detect early therapy response, does the patient respond well to the therapy? Are we on the right track with that therapy? That maybe initially you really test every month. In the follow-ups, you know, when the patient gets scans every three, later every six months, maybe one additional time point in between. But on how often exactly – ultimately it's going to be the physician's responsibility and also they know much better on how.

Alex, X-Health.show: 23:12

No doubt about that.

Dr. Claudia Scheckel, Oncobit: 23:13

Exactly.

Alex, X-Health.show: 23:23

So they would basically have more information about the progress or about the cancer not progressing, and they can adjust the treatment or change the medication or think of other solutions.

Dr. Claudia Scheckel, Oncobit: 23:38

Right, exactly. So we wanted to really come up with a solution that allows this very frequent monitoring of the patients for really an optimal therapy management.

Alex, X-Health.show: 23:52

[MID-ROLL BREAK] This episode is brought to you by the X-Health. show and me.

Alex, X-Health.show: 23:56

So if you like this podcast, be generous, hit: Follow, leave a review. That'll help me invite more such amazing guests for you. Thank you. [END MID-ROLL] So could you now just tell about the product, so about the Oncobit PM. So, you know, there is a cancer clinic that would like to use that solution to help their patients. How would they work, so what could be the workflow? Or what is the workflow that one of the clinics that you cooperate now with work with.

Dr. Claudia Scheckel, Oncobit: 24:31

We have regulatory approval. That's important, of course in Europe, actually, for that test, the healthcare system is quite complex, of course. So it's not just the regulatory approval you need but, as I already mentioned, we need a lot more clinical data to really get into the routine, and we're working on that with, as I said, many collaborations. And then a third big component is reimbursement, so health insurance is needed to to reimburse. In Switzerland we're lucky the test is already reimbursed if it's performed at the hospitals. So at the moment we essentially start to enter the market with two different models.

Dr. Claudia Scheckel, Oncobit: 25:07

I already mentioned that we want to enable hospitals to perform the tests themselves, but at the moment, digital PCR is still a relatively new technology, and so it's not broadly used yet. That's why we are starting right now also with offering it as a service. We have here a fully equipped lab set up just outside of Zurich, and so what the hospitals can do is essentially just send us the blood samples. They need to collect the blood in special tubes that stabilize the tumor DNA in the blood, they send us these blood samples and then we are processing everything. And so with processing, this means on one hand, we perform the test, so our Oncobit PM test, which runs on, as I mentioned, existing machines, but then something that's absolutely critical of our test as well is our software. So the data that is generated is analyzed with our PM software. And what the software does is was trained on healthy data and thousands of samples were run with this software, and based on this existing data, the software decides on how to classify the patient sample.

Alex, X-Health.show: 26:13

So we're speaking machine learning or AI, artificial intelligence?

Dr. Claudia Scheckel, Oncobit: 26:19

More machine learning. And the software then helps us to eliminate biases, on one hand, it has integrated quality control checks but it also allows us, because of this integrated QC checks, quality control checks, that the hospitals in the long run can perform the test themselves. Because what the software does, it runs together with a positive control and it immediately checks certain boxes if everything looks fine. If it was run at a hospital, for example. And if it doesn't, it will flag automatically the samples that something was not correctly performed, essentially. And so what comes out of this software is then, besides of course that everything is automated, so the analysis, interpretation and also reporting, so what comes out is more robust data. That is really that takes, as I mentioned, healthy data into account when classifying a patient sample, and if you work with ultra sensitive technologies, that's actually quite critical. So there was something that was quite important to us that we had a standardized data analysis to really provide more confidence into the results that we can deliver.

Alex, X-Health.show: 27:45

Let's just move back in time a bit to the founding of Oncobit. Could you tell a bit more about the founders, the two founders, why they actually founded the company and how the idea changed from the beginning to what it is now available at least in Switzerland and soon outside.

Dr. Claudia Scheckel, Oncobit: 28:08

Two of my co- founders are professors at the University Hospital and they were essentially not satisfied with what was being used in terms of diagnostics and monitoring when it came to melanoma, and that was really the starting point. So Oncobit was really founded out of an unmet need. They then got together with two bioinformatic entrepreneurs who thought, well, let's commercialize this, let's not make this only available to patients at the University Hospital of Zurich, but rather to a broader patient population. And that was sort of the starting point. And then I myself joined as a co- founder and CEO a little more than three years ago.

Alex, X-Health.show: 28:49

Is it still the same idea? Or was it pivoting?

Dr. Claudia Scheckel, Oncobit: 28:52

Yeah, we definitely started more with a diagnostic focus. So I mentioned that the tumor tissue is tested for many, many different markers and we developed or my co-f ounders developed a very comprehensive test for that and that test is actually still used in diagnostics at the University Hospital of Zurich. But we saw this larger unmet need when it came to monitoring and where we really felt we could more quickly make a bigger difference. And so that was why we pivoted a little bit and have now a very, very strong focus on monitoring.

Alex, X-Health.show: 29:33

Is there a limit to iterations?

Dr. Claudia Scheckel, Oncobit: 29:36

So it depends on what you mean with iterations.

Alex, X-Health.show: 29:40

It's a general question and it's a startup, so I mean, on one hand, startups are there to be agile and to, adjusting according to the situation. I'm just wondering, if there's a limit.

Dr. Claudia Scheckel, Oncobit: 29:57

I mean, I wouldn't say there is a limit, but since we're working in the healthcare industry, even though you're a startup, it's a very regulated market and you have to fulfill a lot of regulatory requirements. To get CE marking is not trivial. And if you get CE marking and then don't want to use that test, then that you should have pivoted before that, I would say. Alex, X-Health. show: You should know what you are actually certifying for.

Dr. Claudia Scheckel, Oncobit: 30:27

Dr. Claudia Scheckel, Oncobit: Yes, because it's not a fast thing to do, also for a startup. But at the same time, I already mentioned that our PM test is a platform technology, so that means it exists of the software that I mentioned that is really important for the classification of the samples, but also tests that then detect these different markers. And so, for example, we started off with the most critical melanoma marker,BRAF E600, that I already mentioned a few times. But by now, we have four additional melanoma markers and all of those are right now under regulatory review. And so that's what I meant with "what you mean with iterations" because also our software, of course, has gone through a lot of improvements since the initial version. And I think you can't stand still. With more data, we're improving our solutions and that's absolutely critical.

Dr. Claudia Scheckel, Oncobit: 31:22

Because of this regulated market, you can't just make a change and then the next day it's going to be available to the patients. I t needs to go through vigorous testing and again through regulatory approval. A s I said, it depends on how you define iterations and for us it's a platform technology, so it's going to be very normal to now add additional markers that are not relevant to melanoma anymore but to other cancers. That's very easy for us and that's, yeah, like you said, we are agile, we're a startup. It's quite easy for us to expand there.

Alex, X-Health.show: 31:55

So these will be additional CE marks to what you have now.

Dr. Claudia Scheckel, Oncobit: 32:01

Yeah, so right now the initial CE marking is really for this one marker, and the other four markers are under review. Alex, X-Health. show: Let me just say, congratulations. Dr. Claudia Scheckel, Oncobit: Thank you.

Alex, X-Health.show: 32:12

If you could also say a bit more about the whole process because you've received the CE mark. What's the process to receive that? So that also our listeners know, how long does it take actually to be able to enter the market.

Dr. Claudia Scheckel, Oncobit: 32:32

There was a recent change in the law in Europe to make the market a little bit more regulated, and we are much closer now to what the FDA requirements in the US are than we were before. And so I should say that the CE mark that we already have is still under the old law. But even with the old law we already fulfilled all of the requirements of the new law. So we knew the new law was coming and so it was clear for us that we already wanted to fulfill these requirements. But the advantage of getting CE marked still under the old law was that we didn't have to go through the review process, which in itself takes nine to 12 months.

Dr. Claudia Scheckel, Oncobit: 33:11

So while we are quite fast on the development side, the review process is something we can't really influence much. I mean, we can be, we can try to be optimally prepared for that, and we have tried. And so far with all our audits they're very positive. But at the same time you never know what might come up during a review process. And so, I would say, by now, with the experience we have to add an additional marker is several months to maybe half a year but then the review of this can take up to up to a year. That's then really out of our hands, well, largely out of our hands, of course, we have to respond to the reviews but it depends a lot on our notified body that performs this review.

Dr. Claudia Scheckel, Oncobit: 33:59

Alex, X-Health. show: Speaking of a startup journey, could you tell a bit about the milestones that you went through. For example, financially wise. What was that made you, well, grow. Dr. Claudia Scheckel, Oncbit: We closed a seed round two and a half years ago, actually almost two and a half years ago and that allowed us to, on one hand, build up a quality management system, get ISO certification for that ISO 13485. So that's essentially gives you the credibility that you can develop diagnostic and monitoring solutions for cancer in our case. So that was early last year that we got our ISO 13485 certification. It was also the requirement to get CE marking of our products and that was then the next milestone, that we actually CE marked our first marker. Also, now that we already expanded to four additional markers, we also now split our product, that the software is a standalone product.

Dr. Claudia Scheckel, Oncobit: 35:04

Everything is, as I mentioned now, under review and we've learned a lot about how how different it is to go from a research test and a university setting to a regulatory approved product, and w e had a lot of support from consultants, but we the whole team really got together and built that quality management system on one hand, but also that knowledge that you need to really bring products on the market. And that was actually really fantastic to see how the team rose up and tackled that challenge.

Alex, X-Health.show: 35:39

So who's on the team, who's crucial on the team?

Dr. Claudia Scheckel, Oncobit: 35:44

I think at a startup, everyone is crucial. We are 10 people. We are all very scientific, even our Chief Business Officer has a has a PhD in cancer biology.

Dr. Claudia Scheckel, Oncobit: 35:59

I think it's quite important at this stage still because our customers are typically really leading oncologists, so you need to have a very good understanding of the cancer, of the tests, to really have an eye to eye conversation with them. And so Bjoern, he worked for 12 years in industry and also another startup where he worked on business marketing, business development and marketing and sales. Then Elisa is our quality manager. She has been quite involved from the beginning, at first more on the study side – well, she's still involved in that as well but now she's really taken care of the quality management system and the regulatory requirements.

Dr. Claudia Scheckel, Oncobit: 36:43

And then, roughly, our team is split into two halves, kind of reflecting also the nature of our tests. So we have our software development team with very complimentary experience from bioinformatics, analytical software, engineering and statistics. And then on the assay side we have quite experienced molecular biologists and people who also did their PhDs on cancer biology, worked in pathology – again quite complimentary also to really develop something that's useful for physicians and therefore ultimately – the patient.

Alex, X-Health.show: 37:17

Okay, so it sounds like you have everyone you need on the team. Now, when you were looking for investors, did it matter to you I mean, their background did it matter to you? Or was it just that you needed funds to accelerate what you already have?

Dr. Claudia Scheckel, Oncobit: 37:36

I think ideally, of course, you have investors that share the same vision and I think we're lucky that we have those investors on board. So everyone really wants to make a difference for the patients. That's, I think, a big motivator for all our investors At the same time sometimes also you don't have the luxury to choose. But I think that's actually really cool that our investors really share that vision.

Alex, X-Health.show: 38:02

Speaking of investors, are you fundraising right now?

Dr. Claudia Scheckel, Oncobit: 38:06

Yes, so we are a startup, so I think most startups are in fundraising mode all the time. But right now we're raising 3 million to demonstrate commercial proof of concept here in Switzerland, so to implement our tests in the first clinics in Switzerland, to also expand our portfolio further, so our scalable platform technology to other cancer types and with that we can then also start to enter additional markets, the US. So that's then next for Oncobit.

Alex, X-Health.show: 38:37

Any thing particular you're looking for?

Dr. Claudia Scheckel, Oncobit: 38:41

Yeah,

Dr. Claudia Scheckel, Oncobit: 39:01

If we can get investors who share our vision again, but also who have a lot of knowledge when it comes to diagnostics, to market entry in the healthcare system, it's quite particular, it's quite different from other industries, so it's great if investors have that background as well.

Alex, X-Health.show: 39:19

It might be a tough one, but I don't know" Are you successful? You mean?

Dr. Claudia Scheckel, Oncobit: 39:24

You mean... I'm assuming you mean professionally. So I'm very, very proud of the team and what we've managed during the last couple of years, and so we are, of course, not there yet, like we still have quite some important steps to go but I think we are on a very good path and I think we have really a great team to go there. Yeah, I would say" yes. Well, also, what do you mean with you, like you personally or you, you as a team? Right? So yeah, because obviously they are doing most of the work that I then get to talk about. So I think, yeah: yes.

Alex, X-Health.show: 40:08

So what's in the bright future for on Oncobit? If you could just imagine, everything goes as you planned or everything goes as you envision. What's the future you want to see?

Dr. Claudia Scheckel, Oncobit: 40:22

We really want to make a difference for the monitoring of cancer patients. So, with an initial focus on melanoma, that we can really help physicians and therefore really ultimately the patients to better understand their cancer, to hopefully detect it earlier when it comes back, to detect if the patient responds well to a therapy and to immediately adjust it if they don't. And to really make a mark there.

Alex, X-Health.show: 40:48

And going back down to earth, what are the challenges? Or how do you plan to approach them?

Dr. Claudia Scheckel, Oncobit: 40:57

I think one of the bigger challenges right now, especially, while not only in Europe, but in general, because the healthcare market is so complex that you not only have to worry about clinical data and regulatory approval but also, for example, about reimbursement, and then, of course, also hospitals are maybe not the businesses that implement solutions the fastest. If you want to call them businesses, although I think in most countries hospitals actually are businesses and that's actually fair enough, right? Like we're dealing here with the healthcare system, we're dealing with the lives of patients.

Dr. Claudia Scheckel, Oncobit: 41:34

Alex, X-Health. show: S omeone has to pay for it. Dr. Claudia Scheckel, Oncobit: Well, to pay for it but also, I think in many ways it's justified that you don't immediately run after the first new solution, right? You want to make sure that it's really benefiting the patient. But at the same time, of course, it means that it's not the fastest industry to implement new solutions, right? So that's certainly a challenge for startups, where typically the money is not very abundant and you can move fast as a startup. Then you hit reality and you realize, oh, the people you are dealing with are actually maybe moving at a very different pace than you.

Alex, X-Health.show: 42:12

You are a bit too upfront.

Dr. Claudia Scheckel, Oncobit: 42:15

Well, it's just, yeah, we're a small team, we can move quickly, but, of course, a large hospital, where that has to go through a lot of different levels, it's a completely different situation.

Alex, X-Health.show: 42:27

So where do you find fuel for it? How do you recharge? How do you accelerate? What do you need to accelerate?

Dr. Claudia Scheckel, Oncobit: 42:35

I think I generally have a high energy level, I would say, but I do definitely really try and keep my weekends free, for example. I really love to be out in the nature and doing sports, being in the mountains, kind of seeing something different.

Alex, X-Health.show: 42:54

It's actually scientifically proven, it works. So probably did the right thing there.

Dr. Claudia Scheckel, Oncobit: 43:26

I mean, that's great, we're in Switzerland, you can get out to the mountains quickly –with sunscreen.

Alex, X-Health.show: 43:32

So what's right next for Oncobit? In the immediate future.

Dr. Claudia Scheckel, Oncobit: 43:37

So right now we're talking to Swiss hospitals to start implementing our test. As I mentioned, we do need more data to really get a very precise idea on how often and when to use the test but there are already now patients that the physicians don't really know on how to proceed with and that's exactly where we can come in and provide an additional data piece that hopefully helps to decide on how to proceed with therapy or with a different therapy. And so we're working on that right now. With the regulatory approved test, we are also already now to start to expand beyond melanoma.

Dr. Claudia Scheckel, Oncobit: 44:21

So one of the marker that I mentioned is actually also critical for other cancer types. We need to expand on the clinical data but the test itself is actually already done, is ready to go. So those are immediate next steps but then, in the long run, we want to... So digital PCR can be used to just look at one specific marker but we also want to expand to something called multiplex approach. Then not just only detect a single marker but multiple markers. And that opens up a lot of additional indications that you can look at and new possibilities.

Alex, X-Health.show: 44:57

Okay, it looks like there's a lot coming up. So thank you, Claudia, for this conversation. Dr. Claudia Scheckel, Oncobit: Thank you, Alex. Alex, X-Health. show: And for you guys listening, if you want to learn more about Oncobit, please go to oncobit. com. Thanks again, thank you. [POST-ROLL] I'm totally impressed by the audacity of researchers turned startup founders, doctors turned entrepreneurs or ordinary parents turned healthcare innovators. People battling the battles that no one fought before. For the eXtra health of the future. So if you see a startup posting on LinkedIn, show them some love, hit Like, comment: That's fabulous. If you have a couple of drops more of that altruism, follow the X-Health. show, leave a review here. I'll be able to bring more of these visionaries to you. So a big thank you. You're awesome. See you next week.