ClarityDX Prostate®: Redefining Precision Medicine and Transforming Prostate Cancer Diagnostics
Prostate cancer is a major concern for men's health, with early detection being vital for effective treatment. It remains the most commonly diagnosed non-skin cancer among Canadian men, and traditional methods like the Prostate-Specific Antigen (PSA) test often result in false positives, leading to unnecessary biopsies. ClarityDX Prostate, developed by Nanostics, an Alberta-based precision health company, in collaboration with the Alberta Prostate Cancer Research Initiative (APCaRI), offers a non-invasive, precise solution for predicting prostate cancer and represents a transformative step forward in prostate cancer screening.
This simple blood test utilizes a unique combination of biomarker analyses and machine learning (ML) to predict the risk of clinically significant prostate cancer with up to 4 fold more accuracy than the traditional PSA test. By incorporating clinical data such as patient age, previous negative biopsies, Digital Rectal Exam (DRE), and MRI data (prostate volume and Prostate Imaging Reporting & Data System score (PI-RADS)), the ClarityDX Prostate test provides a comprehensive risk score, helping clinicians make more informed decisions about the need for further screening or intervention, triggered by elevated PSA levels.
The development of ClarityDX Prostate, a cutting-edge diagnostic tool, has been a journey filled with challenges, innovation, and determination. In an interview, Dr. Desmond Pink, Chief Scientific Officer (CSO) of Nanostics, and Dr. Perrin Beatty, Communication Coordinator, shared their insights into the development of Clarity DX Prostate and future applications.
The Biggest Challenge
One of the most significant hurdles in bringing ClarityDX Prostate to life was understanding the full scope of what the test could offer. "When you start out, it’s just an idea. As you walk that path, the notion gets more refined or you pivot completely," explains Desmond. This refinement process involved identifying key stakeholders – from patients and clinicians to payers – and ensuring the test would benefit all parties involved.
However, as with many healthcare innovations, the biggest challenge was securing funding Desmond said. “Taking the test from an academic idea to a developed product requires a lot more resources—financial, technical, and biological—than people initially think”. In this scenario financial covers expanding clinical studies, technical means hitting regulatory checkpoints and biological resources refer to obtaining the required numbers for diversity and number of patient samples.
Perrin also noted that overcoming the academic versus entrepreneurial mindset was crucial. "The academic and the entrepreneurial mindsets are infrequently aligned," she said. This shift in thinking was essential in pushing forward despite numerous roadblocks. Both Desmond and Perrin highlighted the importance of meeting the patient’s needs in the development of ClarityDX Prostate, which is the main focus of the Nanostics’ team.
Regulatory Compliance: An Essential Pathway
The regulatory landscape, while often seen as a barrier, was approached differently by the Nanostics team. "Regulatory is most often considered a hurdle, but it’s not. It’s a fact, and you have to achieve it for patient safety," Desmond Pink Nanostics’ CSO remarks. Although the paperwork can be overwhelming, the checks and balances ensure that both the test and the process are safe, secure, and reliable. “It’s important to understand why these requirements are in place—they benefit the scientists, the company, and, most importantly, the patients.”
ClarityDX Prostate is on track to meet regulatory approval not only in Canada but also internationally. The team is working towards FDA approval in the United States with plans to expand globally. "Yes, it takes time, but we are getting there," confirms Desmond.
Leveraging Data and Patient-Specific Factors
ClarityDX Prostate uses advanced algorithms to integrate blood-based biomarker levels and patient-specific clinical features into its risk assessment model. While the specifics of the algorithm remain confidential, Desmond mentioned ongoing research and publications that delve deeper into how these factors influence the test’s predictive capabilities. Access to patient data plays a vital role in improving the accuracy of ClarityDX Prostate. The focus on using real-world data and patient samples ensures that ClarityDX Prostate remains at the forefront of prostate cancer diagnostics.
Future Applications of the ClarityDX Platform
Looking ahead, the team sees tremendous potential for the ClarityDX platform beyond prostate cancer. “We are exploring other disease indications like bladder cancer,” shares Desmond Pink. By integrating clinical data with biomarker data, the team is working on identifying aggressive diseases early. “This marriage of data points will provide a cleaner, more accurate diagnosis and aid in developing future iterations of ClarityDX” he adds.
Advancing Through Collaboration, AI, and Machine Learning
Securing provincial healthcare coverage for ClarityDX Prostate remains a pivotal objective for Nanostics. Desmond notes, "We plan to conduct a clinical utility study to validate the test's effectiveness and integrate it as a standard component of men's healthcare." Perrin Beatty adds, "ClarityDX Prostate is a simple, minimally invasive, cost-effective, and timely diagnostic tool that can fit seamlessly into the current standard of care."
Collaboration has played a key role in Nanostics' success, particularly with its partnership with DynaLife, a medical diagnostics company purchased in 2023 by AHS-owned Alberta Precision Laboratories. "Their mentorship was invaluable, guiding us through both the technical and business aspects of healthcare," says Desmond Pink. DynaLife’s support significantly accelerated the team's progress, helping them navigate complex logistics, regulatory challenges, and practical issues like sample transportation and providing insights that would have otherwise taken years to master.
Machine learning algorithms are critical to Nanostics' innovation strategy. "We focus on the big picture with ML, but it's also the everyday applications that can truly make a difference," explains Desmond. ML is already enhancing diagnostic processes, improving speed and accuracy, with future ambitions aimed at expanding the use of biomarker analysis to other cancers, such as bladder cancer.
Advice for Aspiring Professionals: Lessons from the Nanostics Team
The Nanostics team emphasizes the importance of a mix of education, experience, and adaptability, particularly for people aspiring to grow in precision health companies. Finding the right mentorship at the right time is critical for building a successful team leading through the development of a medical device. Desmond is quick to point out that formal education alone isn't sufficient. "A lot of being successful in a biotech startup comes down to experience and the ability to handle everything, everywhere, all at once," he explains, underscoring the need to juggle multiple roles in a fast-paced, start-up environment. Perrin added that at multiple timepoints during a biotech startup’s technology readiness levels (TRL) journey from idea to product, the need for a scientific mindset is useful but needs to be balanced with the right tone and language to communicate the intended message to a diverse audience. "In science communication, formal education may not be the most important factor, you need to be able to switch hats quickly to help your team succeed," she says, stressing the importance of adaptability.
Dr. Argo Basu, Senior Scientist and Clinical Laboratory Manager at Nanostics, reinforces these perspectives by drawing on his own experience. "My diverse experience, spanning biochemistry, molecular biology, and the development of diagnostic tools, has equipped me with a unique ability to oversee complex laboratory processes. This blend of expertise enables me to efficiently manage the intersection of scientific research and practical diagnostics, helping our team deliver high-quality, reliable results while running a state-of-the-art clinical laboratory." His words highlight how multidisciplinary expertise and hands-on experience are critical in delivering reliable outcomes, especially in fast-evolving biotech environments like Nanostics.
ClarityDX Prostate: A Game-Changer in Cancer Diagnostics
ClarityDX Prostate continues to push the boundaries in cancer diagnostics. For men with elevated PSA levels, ClarityDX Prostate offers a much-needed, highly accurate, diagnostic tool that can clarify the decision-making on treatment paths and provide peace of mind for patients and their families. As life sciences professionals, it's our responsibility to raise awareness about such advancements that are developed in Canada, but may be beneficial to every human being in every corner of the world. The more we amplify the conversation around innovative diagnostics like ClarityDX Prostate, the closer we get to erasing the fear of cancer through early detection and effective treatment.
Let’s use Prostate Cancer Awareness Month to make noise and ensure that everyone who could benefit from this test is aware of its potential. As the Nanostics team demonstrates, true innovation in healthcare isn't just about developing cutting-edge technologies; it's about making those breakthroughs accessible to everyone.
For more information about the ClarityDX Prostate test, visit the Nanostics’ website.
References
Cancer Research UK. (2021). Prostate cancer statistics. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/prostate-cancer
Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9. PMID: 38902526; PMCID: PMC11190196.
Mason, R. J., Marzouk, K., Finelli, A., Saad, F., So, A. I., Violette, P. D., Breau, R. H., & Rendon, R. A. (2022). UPDATE – 2022 Canadian Urological Association recommendations on prostate cancer screening and early diagnosis: Endorsement of the 2021 Cancer Care Ontario guidelines on prostate multiparametric magnetic resonance imaging. Canadian Urological Association Journal, 16(4), E184. https://doi.org/10.5489/cuaj.7851
Nanostics. (2023, September 28). Nanostics launches ClarityDX Prostate test in Alberta to significantly improve prostate cancer screening. Newswire Canada. https://www.newswire.ca/news-releases/nanostics-launches-claritydx-prostate-test-in-alberta-to-significantly-improve-prostate-cancer-screening-807242360.html
Nanostics. (2024, January 10). A better way: How Nanostics is revolutionizing prostate cancer detection. Disruption Magazine Special Issue 21. https://www.disruptionmagazine.ca/revolutionizing-prostate-cancer-detection
Preprint citation Paproski, RJ, Kinnaird, A., Hyndman, M.E., Fairey, A, Marks, L., Pavlovich, C., Fletcher, S.A., Zachoval, R, Adamcova, V, Stejskal, J, Aprikian, A, Wallis, C J.D., and Pink, D, Vasquez, C, Beatty, PH. and Lewis, John D., Predicting Clinically Significant Prostate Cancer with or Without Digital Rectal Exam and MRI Data Using ClarityDX Prostate Models. Available at SSRN: https://ssrn.com/abstract=4943735 or http://dx.doi.org/10.2139/ssrn.494373
