Catalina Vasquez is co-founder and COO of Nanostics Inc., a Canadian biotechnology company that develops and commercializes innovative diagnostic tests. Established in 2017, Nanostics leverages machine learning to generate biomarker-driven improvements to patient care. It aims to revolutionize personalized medicine through early and accurate disease detection.
Catalina and Wendy connected at the Redefining Early Stage of Investment (RESI) Conference in Boston, hosted by Life Science Nation. (Wendy recently interviewed Dennis Ford, founder and CEO of Life Science Nation, which specializes in fundraising for life sciences companies.)
At the heart of the company's origin story is Frank Sojonky, a visionary whose late-stage prostate cancer diagnosis proved a pivotal moment of transformation, both personally and professionally. His life’s work became an extraordinary commitment to advancing research to prevent other families from experiencing the same devastating experience.
Sojonky's vision took root through strategic fundraising and a partnership with the Alberta Cancer Foundation. His legacy became the cornerstone of what would evolve into ClarityDX Prostate (CDX Prostate in the US), a more precise and reliable blood test alternative to existing methods.
The Science Behind the Innovation
At its technological core, Nanostics represents the cutting edge of medical artificial intelligence. The company’s proprietary approach harnesses machine learning to integrate complex clinical data with standard and proprietary biomarkers. The result is a sophisticated algorithm that generates a precise risk score, predicting the presence of clinically significant prostate cancer with unprecedented accuracy.
The advantage of ClarityDx Prostate is that it is software as a medical device. It's an algorithm.
What that means is that we don't need blood samples. We don't need to run advanced complex molecular tests that bind you to a particular lab that is the only lab that can run it. We partner with specific labs that have a large representation in the community, in the country, that have a vast network and a good number of patients. They run PSA tests, send us all the data we need, we run the algorithm, and then send the results back to them.
What sets Nanostics apart is its ability to differentiate between aggressive prostate cancer and indolent forms of the disease, meaning cases that are asymptomatic or marked by slow progression. By providing a percentage-based risk assessment, the technology empowers both patients and physicians to make more informed decisions about potential biopsies, which come with “significant adverse effects,” even death.
Global Validation Through Rigorous International Research
The company included a comprehensive international validation strategy designed to recruit over 3,400 patients across multiple countries, including Canada, the US, and Europe. This ambitious approach involved collaborations with prestigious institutions like UCLA, Johns Hopkins University, University of Calgary, University of Alberta, and Thomayer University in Europe.
As soon as the company launched its clinical trials, the COVID-19 pandemic happened, temporarily halting patient recruitment at multiple sites. Catalina and her team were unfazed, however, and she says:
In reality, after COVID abated it was actually quite easy to recruit for this study because patients really, really wanted to help. So out of a hundred patients, 97-98 of the patients would agree to participate in the study. Because of that, the recruitment was super quick. We were able to recruit 1500 patients in less than a year.
There is a worldwide need for improved prostate cancer screening. Marketing in different regions requires a nuanced understanding of cultural differences in healthcare. As such, the company doesn't simply deploy a one-size-fits-all solution but carefully adapts its technology and messaging to specific regional contexts:
- In Colombia, where men often pursue biopsies out of extreme cancer anxiety, Nanostics offers a way to reduce unnecessary medical procedures
- In the Middle East, where cultural taboos can prevent men from seeking medical examinations, their technology provides a less invasive alternative to traditional screening methods
- In North American markets, they offer comprehensive models that incorporate multiple standard-of-care diagnostic approaches
Catalina emphasizes that global expansion involves scientific adaptation and communication strategies. Marketing materials are meticulously tailored to local sensitivities. In more conservative regions like the Middle East, messaging becomes more discreet, while markets like Alberta allow for playful, witty approaches.
Expanding Global Reach
Nanostics continues to expand its global footprint, including recent partnerships with:
- Protean BioDiagnostics for the U.S. market
- OncoHelix, serving the Middle East and North Africa
- Prime Diagnostics covering Latin America
- Laboratory partnerships across multiple Canadian provinces
Their software-as-a-medical-device model provides remarkable flexibility, allowing integration with existing laboratory infrastructures worldwide. The potential impact is profound. Nanostics’s improvement in PSA testing predictive values could prevent up to 47% of unnecessary biopsies. This isn't just a statistical achievement but a profoundly human one—reducing patient anxiety, preventing potential medical complications, and ultimately saving lives.
Links:
Website: https://www.nanosticsdx.com/
LinkedIn: https://www.linkedin.com/in/catalina-vasquez-994371b4/
Connect with Wendy: https://www.linkedin.com/in/wendypease/
Music: Fiddle-De-Dee by Shane Ivers - https://www.silvermansound.com
ATTENTION: Below is a machine-generated transcription of the podcast. Yes, here at Rapport International we talk a lot about how machine translation lacks quality. Here you see an example of what a machine can do in your own language. This transcription is provided as a gist and to give time indicators to find a topic of interest.
Wendy: Welcome to The Global Marketing Show. I'm very excited to be recording live here at the RESI conference in Boston. And as you know, The Global Marketing Show is brought to you by Rapport International and they always like to give us a tidbit to start out with. So we'll do that too. And did you know that twisting your nose when you're in France, signals that you see a drunk person? I didn't know that, but now I know when people are twisting their nose that that's what's going on. And I think it's so appropriate for today because our guest is from Canada, so we can ask her if it's the same in the French-speaking part of Canada.
Our guest is Catalina Vasquez, and she's from Nanostics Inc. She's co-founder and CEO, so Catalina, welcome.
Catalina: Thank you very much. Thank you for the invitation. I'm very excited to be here today.
Wendy: Yes. So is it the same thing? Do people in Canada, the French-speaking part wrinkle their nose?
Catalina: No, that I know of. No. [00:01:00]
Wendy: Yes. See, there are very big cultural differences, even if you speak the same language. So tell me about your company and what brings you to RESI.
Catalina: Yeah. So Nanostics is a diagnostics platform company founded in 2017 with the mission of providing clarity to our patients and doctors about their health status by providing better diagnostics.
At the core of Nanostics, what we do is we use machine learning to integrate clinical data from the patient along with standard of care biomarkers or some proprietary biomarkers, we combine it using machine learning to come up with a risk score, which is a prediction of the presence of the disease.
And our first test is in prostate cancer. It's called ClarityDX Prostate in Canada. We just launched in the United States yesterday, so this comes very timely, I'm very happy to announce that. And the name in the United States is going to [00:02:00] be CDX Prostate. And it's basically an algorithm that predicts the risk of having clinically significant or high grade prostate cancer.
Wendy: Wow. Well, that's such good news that you launched here. So tell me a little bit about your journey. You started in Canada and is the US the first country you're going into? Like what's your global launch plan?
Catalina: Right. I'm going to start with a little bit of a story and then answer your question.
So the company on the test was born based on the vision and trust of a gentleman called Frank Sojonky. Frank Sojonky, unfortunately, was diagnosed with prostate cancer late and that meant that his cancer metastasized and he died from prostate cancer, unfortunately. But before he died, he made his mission to help research to develop better tests for early diagnosis of prostate cancer.
So through his vision and his [00:03:00] fundraising efforts, in partnership with the Alberta Cancer Foundation, which is a local foundation in the province of Alberta, they got the funding to support our research. And as a product of that, we developed ClarityDX Prostate. When we developed that in 2017, we launched the company and continued working validating the test.
So we did an international clinical study, recruited over 3, 400 patients in Canada, the United States, and Europe.
Wendy: Okay, so hang on, you got to dig deeper into that in that story. So you did international clinical studies. Right. A lot of companies are afraid of doing clinical studies outside of their own country because they're afraid of the culture, the language, the regulatory environment, the IP protection, all of that.
So talk to me about how you decided to do that and how it played out?
Catalina: Well, it was a no brainer. We wanted to ensure that the product will launch if at the end we ended up having [00:04:00] a product that was solid. We didn't want to have the bugging your mind, hesitating, doubting if the test is really good, right?
So we decided to validate it in multiple cohorts with multiple groups including UCLA, John Hopkins, University of Calgary, University of Alberta, and Thomayer University in Europe.
Wendy: And so how did you find them and establish relationships enough to do that?
Catalina: Through our network because we started an academic research program thanks to the funds from the bird dogs in the Alberta Cancer Foundation. For over five years we were able to develop this massive biorepository and database. And through that we were able to collaborate with multiple institutions across the world. And we created a lot of very strong relationships and connections with them and so that has helped us with the validation plan.
Wendy: Oh, fantastic. Okay. And did you have any struggles or challenges when you were doing your clinical trials? Like what advice would you have? [00:05:00]
Catalina: Yes. You know what happened? We launched the clinical trial and then COVID hit. Oh no. For about a year, the clinics were closed. We opened multiple sites in the United States.
We sent all the material, we paid all the fees, we had ethics approvals, and then COVID hit, and they no longer have patients come to the clinic, so they couldn't recruit any patients. So, we had about five sites across North America that we could never recruit patients. But there were other sites that later on opened, and so then we started doing the recruitment there.
Wendy: Okay, so if you're launching internationally, don't do it during the year of a major epidemic. How about some of the other challenges? I guess that one would be the big one. After that, everything was easy.
Catalina: In reality, after COVID weighing down and [00:06:00] it was actually quite easy to recruit for this study because patients really, really wanted to help. So out of a hundred patients, 97-98 of the patients would agree to participate in the study. So once that went down, the recruitment was super quick. We were able to recruit 1500 patients in less than a year.
Wendy: Wow, and did you recruit only in English or did you use any other language?
Only in English. Okay. Okay, so all of your work has only been done in English to this point? In English, that's right. Oh my goodness, wow.
Catalina: That's right. Having said that, at this very moment, we're enriching our cohorts with patients from Latin America and African American descent in the United States and that will support our FDA application.
Wendy: Oh, to get more of the cross-cultural representation. Exactly. And how are you going to reach out to the Latin American communities?
Catalina: So what we're doing is we're partnering with institutions that serve a lot of those communities, and so they're going to provide us with the data we need to do the [00:07:00] validation.
As we speak, we are working with some groups in Michigan, Maryland, and Florida.
Wendy: Which have heavy Spanish-speaking populations. Yes. So then you'll have to translate all the recruitment materials and patient authorizations.
Catalina: And then, so, when we launched the test, we had our own little accredited lab in Alberta. So we initially launched in Alberta about a year ago.
But then what we have been doing is because we recognize that the test is very beneficial for a lot of men to avoid unnecessary biopsies, and we want to make it available to any men anywhere in the world, we started expanding. So from Alberta, then we have been partnering with multiple labs in Canada to offer the test in BC, Alberta, Saskatchewan, Ontario, and Quebec, and the Yukon in the territories as well.
And we launched in the United States. States in Florida with our partner Protean BioDiagnostics yesterday, and then we are also [00:08:00] announcing another partnership with a lab called OncoHelix that will serve the Middle East and North Africa.
Wendy: Oh, wow. So this is the big announcement of your expanding globally into the Middle East.
Congratulations. What good timing.
Catalina: Thank you very much. And we're also announcing later on a partnership with a lab called Prime Diagnostics in Colombia, and that will serve Latin America.
Wendy: Okay, so talk to me more about these partnerships. What kind of partnerships are they, and how will they be using your diagnostics?
Catalina: Right. So the advantage of ClarityDx Prostate is that it is a software as a medical device. It's an algorithm. What that means is we don't need blood samples. We don't need to run advanced complex molecular tests that bind you to a particular lab that is the only lab that can run it.
Because we use clinical data and lab data that is part of standard of care like free PSA [00:09:00] testing. Virtually any lab in the world could run those tests. So what we do is we partner with specific labs that have a large representation in the community, in the country, that have a vast network and a good number of patients.
And so we partner with them for them to offer these tests to their communities. So they run PSA tests, send us all the data we need, we run the algorithm, and then send the results back to them.
Wendy: Okay, so they're already gathering the information, but when they send it to you, you've figured out how to project it. Exactly.
So you're telling them as to whether they're going to get prostate cancer? Right. It's an early detection.
Catalina: It's early detection. What we do is we come up with the risk that the patient has prostate cancer now. It's not that they're going to develop, it's if they have it now. And we also are able to differentiate between what we call high-risk or high-grade or aggressive prostate cancer versus [00:10:00] indolent prostate cancer. So we discriminate that and so what we give is a risk score, which is a percentage. So basically we say to a patient, hey you have 85 percent risk of having clinically significant prostate cancer. Or you have 2 percent risk of having clinically significant prostate cancer.
So with that information the doctors and patients can make a better informed decision of whether or not to biopsy the patient. And this is very important because biopsies come with significant adverse events. Right. In fact, we have had patients in our cohorts die of sepsis from the biopsy. Oh my gosh.
For the family to find out later on that the patient did not have prostate cancer so that's what we want to avoid. Upto 85 percent of biopsies come back negative. So with our tests, what we do is we improve the predictive value of the PSA test by up to four times. Wow. So we can avoid up to [00:11:00] 47 percent unnecessary biopsies.
And so what we want to do is make these tests available globally so then men don't have to undergo biopsies if they don't need them.
Wendy: Okay. And so you're launching in the US and you're going into the Middle East and South America, have you done any studies where what markets would be better or like picking which regions that you're going to, or you know that this is needed worldwide?
Catalina: It is needed worldwide. There are a lot of differences between cultures in terms of prostate cancer screening.
So for example, one thing I learned, I didn't even know. In Colombia, men are more prone to having biopsies even if they don't need them because they're so scared of having the cancer that they don't mind having the biopsy.
Fascinating! So a lot of men have negative biopsies, a lot of them, which we can help avoid.
Wendy: Right.
Catalina: Now, if you go to the Middle East, there is a lot of taboo for men going to [00:12:00] the doctor. There is a lot of taboo around the digital rectal exam, so men don't want the doctor poking, like, and trying to see if the prostate is enlarged, right?
So alternatives like these offer a solution where patients don't have to be exposed to the digital rectal exam, for example, if they don't want it. Yes. Because we do have models that work without digital rectal exam. But for those, for example, in Canada and the United States where there is availability of digital rectal exams and MRIs as part of standard of care.
Then we have additional models that are more advanced that provide higher level of accuracy. So basically what we're doing is we're customizing our models to meet the needs of the jurisdictions we work with.
Wendy: Okay, so you're customizing the models and then how do you customize the marketing since we are a global marketing show?
How are you going to market in these places?
Catalina: Yes. So same. So there is difference in the language, but also the [00:13:00] difference in the message. So for communities like Alberta, for example, we can be a little bit more witty and use certain, certain images and certain terms.
But we understand that there are also communities that are more conservative, for example, in the Middle East. Then it will need to be more discreet, so we adapt the marketing, the message, the images that we use based on that.
Wendy: Oh, that's fantastic. Well, I really appreciate you sharing your story on this.
What are you hoping to get out of the RESI conference here today? Oh, great
Catalina: question. Yeah, so we're raising money. So we've come this far with only angel dollars and grants. Non-dilutive funding, but now because we are working on expanding and we have achieved a certain level of expansion in market penetration, what we really want to do is to have a very aggressive sales and marketing campaign now in North America to ensure all men that can benefit from the test do it.
Wendy: That's [00:14:00] fantastic. So we'll certainly share this episode and you can send it out to the funders and this is a good place to be to connect it in with Life Science Nation. As a thank you for doing the podcast today. I would like to give you a copy of the book on global marketing. It sounds like it's good timing as you're reaching out to the global markets.
Catalina: Very nice. Well, thank you very much. Thank you for the present and for the invitation.
Wendy: We always ask what's your favorite foreign word? I can't end the podcast without asking that.
Catalina: Okay. Well, actually, I'm going to respond in inverse. So when I lived, I am from Colombia originally, right? So when I used to live in Colombia, my very favorite foreign word was indeed.
Indeed. And so now in North America it's not foreign, but it was foreign to me, so that's my favorite word. I like how it sounds, and I like how it agrees with [00:15:00] what the person is saying, so it's very nice.
Wendy: Indeed it does. Well, thank you very much. Yes, thank you. So thank you listeners for tuning in to this episode of the podcast.
If you're connected at all in this field, certainly send this episode off to any funders that you know. Let's help the men in our lives with prostate diagnostics. And if you like this episode, please give us a five and follow us. We've got some more episodes coming from the RESI conference.
Thank you. Thank you.

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