Products

Our core technology ClarityDX® can

- - - - Identify biomarkers expressed by diseased cells/tissues
        
        Indicate if treatment is needed
        
        Predict treatment response and resistance
        
        Stratify disease stage
        
        Identify disease recurrence

When ClarityDX Prostate® comes to market, it will help physicians and patients navigate biopsy
decision at TWO critical points in care

Initial diagnosis:

ClarityDX Prostate® is designed to accurately predict the presence of clinically significant prostate cancer
and with the guidance of a physician can be used to inform the decision to biopsy.

Active surveillance:

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.

The ClarityDX Prostate® test was validated in two prospective clinical trials in partnership with APCaRI and DynaLIFE.

The test achieved accuracy measurements of > 0.8 AUC (Area Under the Curve) for the identification of clinically significant prostate cancer, compared to 0.58 AUC for the current standard of care Prostate-Specific Antigen (PSA) test.

Our results showed a 40% increase in accuracy over PSA testing.

ClarityDX Prostate®
Prostate cancer blood test.

Sector
Diagnostics and Liquid Biopsy.

Platform
Developed with the ClarityDX® Extracellular Vesicle Machine Learning Analysis Platform.

Clinical Trials
AUC: > 0.8
Sensitivity: 98%
NPV: 98%

Accurate Diagnosis

Our test detects clinically significant prostate cancer with the highest accuracy in prospective clinical trials compared to similar tests in the market.

High Impact

Successful implementation of ClarityDX Prostate® could eliminate up to 600,000 unnecessary biopsies and 24,000 related hospitalizations in North America each year.

Clarity in healthcare decisions

By differentiating between indolent and clinically significant prostate cancer, ClarityDX Prostate® can guide physicians and patients through the decision process. As a result, men may be spared the adverse events of biopsy, prostate cancer surgery, radiotherapy, and hormone therapy.

Cost-effective

When ClarityDX Prostate® gets to the 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.

Clinical utility

ClarityDX Prostate® is designed to be a non-invasive and easily performed test with a small equipment footprint, these features will make this test ideal for large-scale population-based screening in medical clinics, worldwide.

Clinical trials

ClarityDX Prostate® is under development and so currently has not received regulatory approval or clearance in any markets. ClinicalTrials.gov Identifier: NCT03957252

New Applications and Product Pipeline

The ability to detect and measure EVs is transforming the diagnostic landscape in immunology, 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 many diseases and medically-related events. Nanostics’ R&D team continues to expand the product pipeline through in-house and partnered projects to include additional liquid biopsy diagnostic tests to improve patient care.