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.
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.
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:
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.
Nanostics continues to expand its global footprint, including recent partnerships with:
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.