Press Releases

Funding to Propel Widespread Adoption and Integration of Innovative Prostate Cancer Diagnostic Test into Canadian Healthcare

EDMONTON, AB, June 26, 2025 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, announced today significant financial support from Genome Canada and Genome Alberta through the Canadian Biotechnology Innovation and Commercialization Initiative (CBIC) to accelerate the integration of ClarityDX Prostate into the standard of care for prostate cancer screening across Canada. This project is propelled by academic, clinical, and economic collaborations with leadership from Dr. John Lewis, Bird Dogs Chair in Translational Oncology at the University of Alberta, Partnerships and Innovation at Acute Care Alberta (formerly Alberta Health Services), and Nanostics.

ClarityDX Prostate is a laboratory-developed test that uses machine learning to combine clinical and blood-based biomarker data to predict the risk of aggressive, clinically significant prostate cancer and is currently offered as a patient-pay test. This pivotal funding will further support the adoption of ClarityDX Prostate into the standard of care for prostate cancer screening, first in Alberta, then across Canada. The anticipated outcome of this project is a stronger, more responsive, and cost-effective healthcare system for Canadians facing the challenge of prostate cancer.

 The project’s primary objective is to assemble a comprehensive evidence package demonstrating the clinical efficacy and economic value of incorporating ClarityDX Prostate into Canada’s prostate cancer diagnostic pathway. This evidence will help pave the way for reimbursement and increased public accessibility. The evidence package will include results from a clinical utility study, a health impact feasibility study, and a health system integration study.

“We are very grateful for Genome Canada’s support of this project,” said Dr. John Lewis, Bird Dogs Chair of Translational Oncology. “This unique opportunity to collaborate directly with Acute Care Alberta will accelerate adoption of ClarityDX Prostate, and more importantly, help improve the outcomes of men in their journey of screening and diagnosis for prostate cancer.”

“This project is an example of how Acute Care Alberta is collaborating with academia, industry, and care providers to ensure that Albertans have access to the best quality healthcare,” said Tara Klassen Ph.D., Innovation Lead – Surgical Care Alberta “The results from this real-world study will be used to quantify the impact of adopting ClarityDX Prostate into the Alberta and Canadian healthcare systems using in system, on system, for systems science.”

• The first patient was enrolled this month in a Nanostics-sponsored clinical utility study in Calgary to quantify the impact of incorporating ClarityDX Prostate into the standard of care for the early detection of prostate cancer.
• The randomized two-arm control study will recruit up to 1,074 men referred to two urology centres in Alberta.

EDMONTON, AB, April 23, 2025 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, has met a major milestone with the recruitment of the first patient into its recently launched clinical utility study (NCT06678828). The study will quantify the clinical and economic impact of incorporating ClarityDX Prostate into the standard of care for prostate cancer screening.

The Nanostics-sponsored study will recruit 1,074 patients from two Alberta Urology sites, with Dr. Eric Hyndman serving as the principal investigator at the Prostate Cancer Centre in Calgary and Dr. Adam Kinnaird serving as the principal investigator at the Kipnes Urology Centre in Edmonton.

ClarityDX Prostate was previously validated in a 3448-patient study that showed using ClarityDX Prostate as an adjunctive test after an elevated PSA result could more accurately identify men with aggressive prostate cancer sooner, leading to better outcomes while also minimizing the negative effects associated with overdiagnosis of the disease.

“We’re excited to announce the first patient recruited in our ClarityDX Prostate clinical utility study,” said John Lewis, CEO, Nanostics. “The study is designed to further support the use of ClarityDX Prostate as an additional tool for prostate cancer screening and support the wide-scale adoption of the test.”

“If the results of the ClarityDX Prostate validation study hold true for this clinical utility study, a 47% reduction in unnecessary biopsies would be transformative for prostate cancer screening, both for the patient and the healthcare system,” said Dr. John Dushinski, Chief Medical Officer for the Prostate Cancer Centre.

Prostate cancer affects one in six Alberta men, is the second leading cause of cancer death in men in North America, and 1 in 44 will die from it. Some prostate cancers grow slowly and are low risk, while others are aggressive and grow quickly. This disease often progresses with little to no symptoms, which makes early detection a critical component of screening because, when caught early, prostate cancer can often be treated successfully.

Including ClarityDX Prostate into the clinical care pathway for men with elevated PSA levels aligns with the Canadian Urological Association (CUA) recommendation to use adjunctive strategies to better stratify the risk of aggressive prostate cancer. North American and European urology associations also recommend that men with elevated PSA levels use adjunctive tests to better inform their decision to biopsy.

• Nanostics clinical lab relocates to Applied Pharmaceutical Innovation’s newly upgraded Biotechnology Business Development Centre in the Edmonton Research Park.
• Nanostics clinical lab has been granted provisional accreditation from the College of Physicians & Surgeons of Alberta (CPSA) to continue providing its ClarityDX Prostate test to patients.

EDMONTON, AB, April 16, 2025 – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, announced today the provisional accreditation by the College of Physicians and Surgeons of Alberta (CPSA) of its newly relocated clinical laboratory. Nanostics moved its clinical laboratory to the Biotechnology Business Development Centre (BBDC), a hub within the Life Sciences Campus at the Edmonton Research Park managed by Applied Pharmaceutical Innovation (API).

Nanostics clinical laboratory moved from its previous CPSA-accredited location within Alberta Precision Laboratories’ (APL) downtown Edmonton facility, where APL helped support the development of ClarityDX Prostate® into a clinical diagnostic test. Nanostics is proud to continue this collaboration, with APL maintaining its support through sample collection services at patient collection sites across Alberta. Provisional accreditation of the new clinical laboratory means that Nanostics can continue providing ClarityDX Prostate to men in Canada.

“Relocating our clinical testing lab to BBDC is a major milestone for Nanostics,” said John Lewis, CEO of Nanostics. “This new facility offers us expanded laboratory space, providing greater capacity for growth as we continue fulfilling our goal to improve the clinical outcomes of men facing prostate cancer by ensuring they have access to the best tools for managing this challenging disease.

Nanostics is the first clinical testing lab established within the BBDC; located in the Life Sciences Campus, an emerging innovation district anchored by API and home to a growing number of life sciences companies and commercialization facilities dedicated to health innovation.

“Nanostics’ expansion into the BBDC highlights how Alberta-born innovation can scale within the province,” said Andrew MacIsaac, CEO of API. “The BBDC is designed for exactly this—giving high-potential life sciences companies the lab space and support they need to grow, stay competitive, and impact patients here and around the world.”

In North America, about 1 in 8 men will be diagnosed with prostate cancer, and 1 in 44 men will die of prostate cancer, making it the second-leading cause of cancer death in North American men. Some prostate cancers are low-risk because they grow and spread slowly, while others are aggressive cancers because they grow and spread quickly. When detected early, prostate cancer is one of the most successfully treated types of cancer. When used as an adjunctive test, ClarityDX Prostate helps to identify men with aggressive prostate cancer sooner, leading to better outcomes while also minimizing the negative effects associated with overdiagnosis of the disease.