• Discover the Power of Live Primary Cell Phenomics

  • Learn About Cellanyx's Machine Vision and Machine Learning Technology

  • Advancing a Precision Risk Stratification Test

  • Meet the Team Developing a Personalized Risk Stratification Test

  • Cellanyx Has Unlocked Novel Phenotypic Biomarkers

  • Predictive Phenotypic Solutions

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About

Cellanyx is developing proprietary phenotypic (cell behavior) biomarker tests based on AI-driven analysis of live tumor cells to improve cancer risk-stratification and informed clinical decision making. The Company’s unique approach provides quantitative and actionable information based on analysis of thousands of live tumor cells, including cellular behavioral biomarkers, which may be a characteristic of cancer aggressiveness. The Company has demonstrated clinical proof-of concept with its initial laboratory developed test (LDT), for prostate cancer, and has established a pipeline of additional phenotypic tests for other solid tumors, including breast, kidney, bladder and lung cancers.

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Technology

Cellanyx’s technology uniquely analyzes individual “live” tumor cells for cellular behavioral and other markers of cancer and tumor aggressiveness to generate quantitative, actionable information to augment cancer risk stratification. The approach is enabled by a proprietary, breakthrough technique for rapidly culturing primary tumor cells, advanced live cell imaging, machine vision and deep learning and AI that complements machine learning and machine vision technologies.

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Prostate Cancer LDT

Cellanyx’s first LDT is designed to augment prostate cancer biopsy tests, particularly for the tens of thousands of men diagnosed annually with low and/or intermediate grade prostate cancer for which the clinical decisions for surgery, radiation or active surveillance are unclear. The Company has published clinical validation results from a randomized clinical trial, demonstrating the potential of the LDT to predict tumor aggressiveness at the time of surgery. The test has provided the basis and rationale for conducting a clinical utility study at the time of prostate biopsies to enhance the results from prostate biopsy pathology and other tests.

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Prostate Cancer LDT

Cellanyx’s LDT is designed to address the clinical challenges in prostate cancer diagnosis and management. This is particularly important for risk stratification in men with low and intermediate grade prostate cancer (Gleason 6 or 7) and/or for patients that have a negative, prostate pathological score at biopsy, while having an elevated prostate surface antigen (PSA) score.

Prostate cancer is the most common cancer in men but is very heterogeneous. Few patients die from prostate cancer and this presents a major challenge in distinguishing indolent from locally advanced to very aggressive cancer and selecting the best clinical actionability plan. For instance, decisions for active surveillance (also known as watchful waiting) versus definitive treatment with surgery or radiation would benefit from an augmented Gleason pathology score. The Gleason pathological grading system is based on formalin-fixed paraffin embedded (FFPE) prostate biopsy tissue samples that are microscopically evaluated by a board certified pathologist. The Cellanyx score is designed to augment the Gleason score with a Cellanyx to allow better risk stratification of low to medium grade prostate cancers.

Approximately one-half of approximately 1.3 million initial prostate cancer biopsies conducted in the US annually are negative, resulting in a high re-biopsy rate and use of expensive MRI imaging and/or other tests to improve the pathological detection of prostate cancer. The Cellanyx LDT would augment the pathological test results.

Technology Platform

Cellanyx’s technology uniquely enables the use of live single tumor cell analysis that are harvested from tumors to analyze tumor cell morphology and behavior, which is referred to as phenotypic testing. The Cellanyx test measures dynamic molecular and cellular physical (morphologic) characteristics of the tumor cells using advanced microscopy, and machine learning and vision algorithms to allow objective spatial-temporal resolution of biomarker assessment with a single cell resolution.

The technology generates objective, quantitative and predictive measures of adverse pathology to support superior risk stratification. The Company’s technology has resulted in a completely new suite of phenotypic biomarkers, such as cytoskeletal dynamics, adhesion dynamics, tumor micro-environment interactions, and assessment of protein sub-cellular localization, modification, and dynamics.

The Cellanyx phenotypic biomarker platform is objective and distinct, albeit complementary to, traditional light microscopic pathological evaluation of formalin-fixed paraffin-embedded (FFPE) tumor tissue. The Cellanyx technology quantifies many different phenotypic biomarkers via machine vision software. Biomarkers are then selected and objectively ranked by the machine learning algorithms to produce predictive and actionable adverse pathology scores for enhanced cancer risk stratification.

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