Nanostics Inc., a precision health company specializing in diagnostic testing, has received provisional accreditation from the College of Physicians and Surgeons of Alberta (CPSA) for its newly relocated clinical laboratory in Edmonton. The laboratory has moved 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).
The accreditation ensures Nanostics can continue providing its ClarityDX Prostate test to patients across Canada. This diagnostic tool helps identify men with aggressive prostate cancer earlier, potentially improving clinical outcomes while reducing overdiagnosis.
"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."
Strategic Relocation Enhances Diagnostic Capabilities
Nanostics previously operated from a CPSA-accredited location within Alberta Precision Laboratories' (APL) downtown Edmonton facility, where APL supported the development of ClarityDX Prostate into a clinical diagnostic test. Despite the move, Nanostics will maintain its collaboration with APL, which will continue providing sample collection services at patient sites throughout Alberta.
The company becomes the first clinical testing laboratory established within the BBDC, which is part of an emerging innovation district anchored by API and home to numerous life sciences companies and commercialization facilities focused on health innovation.
Andrew MacIsaac, CEO of API, highlighted the significance of this development: "Nanostics' expansion into the BBDC highlights how Alberta-born innovation can scale within the province. 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."
Advanced Diagnostic Technology for Prostate Cancer
Prostate cancer represents a significant health concern in North America, with approximately 1 in 8 men receiving a diagnosis during their lifetime and 1 in 44 men dying from the disease. It ranks as the second-leading cause of cancer death among North American men.
The ClarityDX Prostate test addresses a critical clinical need by helping differentiate between slow-growing, low-risk prostate cancers and aggressive variants that require immediate intervention. The test integrates biological data, clinical information, and AI-powered learning models to generate a risk score for aggressive prostate cancer.
This technology provides crucial support to patients and healthcare providers in making informed decisions about whether to proceed with a biopsy following elevated prostate-specific antigen (PSA) test results or abnormal Digital Rectal Exam (DRE) findings. Early detection of aggressive prostate cancer significantly improves treatment outcomes, while the test's specificity helps minimize unnecessary procedures for men with non-aggressive disease.
Rigorous Accreditation Process
The CPSA accreditation represents a significant achievement for Nanostics, as it validates the quality and reliability of their diagnostic services. As Alberta's medical regulator, the CPSA ensures the safety and quality of medical and diagnostic testing services through its independent accreditation program.
Any laboratory in Alberta that performs and reports diagnostic tests to guide patient care must obtain CPSA accreditation. The assessment process is based on Quality Management Systems recognized by international healthcare external evaluation organizations, making it a rigorous and comprehensive evaluation.
Expanding Access to Advanced Diagnostics
With the successful relocation and accreditation of its clinical laboratory, Nanostics is positioned to expand access to its innovative diagnostic platform. The ClarityDX technology platform uses advanced machine learning algorithms to create disease risk scores that predict the presence of various conditions and is applicable to a wide range of cancers and other diseases.
The company's lead product, ClarityDX Prostate, is currently available to patients in Canada and the United States through various ordering channels. The expanded laboratory facilities at the BBDC will support increased testing capacity and potentially facilitate the development of additional diagnostic applications using the ClarityDX platform.
This development represents a significant advancement in precision diagnostics for prostate cancer and demonstrates how innovative healthcare technologies can be successfully commercialized within Canada's growing life sciences ecosystem.
