Our core technology, ClarityDX, is designed to diagnose disease from a single drop of blood by combining a highly sensitive extracellular vesicle detection platform with advanced machine learning algorithms.
Our lead product currently in development, ClarityDX Prostate, is set to be the most accurate diagnostic test to diagnose aggressive prostate cancer and is positioned to emerge in the near future as the world’s leading diagnostic tool to transform the management of prostate cancer.
In ongoing clinical validation trials, ClarityDX Prostate accurately predicts the presence of clinically significant prostate cancer to inform the decision to biopsy. If the ClarityDX Prostate result informs the decision NOT to biopsy, then a decision tree is followed to select the appropriate time to biopsy.
ClarityDX Prostate can be used to monitor patients on active surveillance to detect the progression to clinically significant prostate cancer and inform the decision to biopsy.
ClarityDX Prostate results are over 40% more accurate than current Prostate Specific Antigen (PSA) testing.
ClarityDX Prostate has been validated in a prospective clinical trial in partnership with the Alberta Prostate Cancer Research Initiative (APCaRI).
In the validation prospective clinical trial, our diagnostic test achieved a > 0.8 AUC (Area Under the Curve, a measure of accuracy) for the identification of high-grade prostate cancer, compared to a 0.58 AUC for the Prostate Specific Antigen (PSA) test, which is the current standard of care.
Extracellular Vesicle Fingerprint for Diagnosis
Sector
Diagnostics and Liquid Biopsy.
Product
Prostate cancer blood test - currently in clinical trials - to identify patients at risk of having aggressive prostate cancer.
AUC: > 0.8
Sensitivity: 98%
NPV: 98%
In ongoing clinical trials, ClarityDX Prostate detects aggressive prostate cancer with the highest accuracy compared to similar tests in the market.
Successful implementation of ClarityDX Prostate could eliminate up to 600,000 unnecessary biopsies and 24,000 related hospitalizations in North America each year.
By differentiating between indolent and aggressive prostate cancer, ClarityDX Prostate will guide clinicians through the decision process to determine if the patient needs cancer treatment, or not. This will tremendously improve the quality of life of millions of men worldwide by sparing them the adverse events of prostate cancer surgery, radiotherapy and hormone therapy.
When ClarityDX Prostate goes to market the test will save an estimated $1.4 billion in healthcare costs by reducing the number of prostate biopsies and unnecessary treatments such as surgery and radiation.
ClarityDX Prostate is non-invasive and its ease of use and small equipment footprint,makes it ideal for large-scale population-based screening in medical clinics, worldwide.
The ability to detect and measure extracellular vesicles (EVs) is transforming the diagnostic landscape in a variety of fields such as immunology, transplant medicine, neurology, cardiology, and oncology.
The ClarityDX platform technology is well positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for a large variety of diseases and medically-related events.
The research and development team at Nanostics continues to expand the ClarityDX platform through our own development and in partnership with others to include additional liquid biopsy diagnostic tests to better manage disease aiming to improve patient care.
Development of the ClarityDX platform for use with many disease targets.
