Machine Learning Improves Diagnostics - Show #137

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. Its larger aim is 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 Sciences 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. 

Through strategic fundraising and a partnership with the Alberta Cancer Foundation, Sojonky's vision took root. His legacy became the cornerstone of what would evolve into ClarityDX Prostate (known as CDX Prostate in the US), a blood test more precise and reliable alternative than 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. So the advantage of ClarityDx Prostate is that it is a software as a medical device. It's an algorithm. 

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. “For the family to find out later on that the patient did not have prostate cancer,” Catalina continues, “that's what we want to avoid.” 

Global Validation Through Rigorous International Research 

The company’s strategy 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. The company’s recruitment strategy originated in English only, but quickly expanded to attract participants from South America and the Middle East, concurrent with a search for more diverse candidates domestically. 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 isn't just about scientific adaptation but also about 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 more 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, and 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 deeply human one – reducing patient anxiety, preventing potential medical complications, and ultimately saving lives. 

Links: 
LinkedIn: https://www.linkedin.com/in/catalina-vasquez-994371b4/ 

Website: https://www.nanosticsdx.com/ 
 

Connect with Wendy - https://www.linkedin.com/in/wendypease/ 

Music: Fiddle-De-Dee by Shane Ivers - https://www.silvermansound.com