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Cellanyx Publishes Clinical Proof-of-Concept Study in Urology of First-in-Class Live Tumor Cell, Phenotypic Biomarker Test to Risk Stratify Prostate Cancer Patients.

M2 PHARMA-November 23, 2018-Cellanyx Publishes Clinical Proof-of-Concept Study in Urology of First-in-Class Live Tumor Cell, Phenotypic Biomarker Test to Risk Stratify Prostate Cancer Patients


- US-based cancer testing platform developer Cellanyx and clinical collaborators have reported results of a prostate cancer clinical study demonstrating the ability of the company's live tumor cell phenotypic biomarker test to identify patients with low and intermediate grade prostate cancer at risk of aggressive disease, the company said.

The results of the risk stratification study, designed to provide a new tool to aid clinical decision making for patient care, are reported on line in the journal Urology.

Prostate cancer is the most common cancer in men in the United States, with an estimated 164,690 news cases diagnosed in 2018, according to the American Cancer Society. Although most men do not die of the disease there will be estimated 39,430 deaths from prostate cancer in 2018.

The inability of current tests to provide risk stratification of aggressive disease in low and intermediate grade patients leads to missed diagnoses, and inadequate treatment.

The study was a multi-center, blinded, prospective trial that evaluated fresh prostate tissue samples taken from 251 men undergoing radical prostatectomy, of which 237 samples were successfully cultured and analyzed.

The samples were evaluated in a central laboratory where they were tested, on a specially coated microfluidic chip and analysed for phenotypic biomarkers in individual cells using machine vision and machine learning algorithms.

The predictions of specific adverse pathology features were then compared to the actual post-surgical pathology reported findings following data un-blinding.

The Cellanyx test accurately predicted post-radical prostatectomy adverse pathology features with an area under the curve through receive operating characteristics analysis of greater than 0.85. The test distinguished among low and intermediate grade cancers (Gleason 3+3, 3+4 and 4+3 and PCGG 1, 2 and 3) with high precision (AUC >0.80).

The live single cell phenotypic biomarker test is being developed as a Laboratory Developed Test that can be run in any CLIA laboratory. The patient sample characteristics and acquisition were designed to fit seamlessly into the workflow of the urologist.

The paper is entitled, "Clinical proof-of-concept of a novel platform utilizing biopsy-derived live single cells, phenotypic biomarkers, and machine learning toward a precision risk stratification test for Prostate Cancer Grade Groups 1 and 2 (Gleason 3+3 and 3+4)."

Cellanyx is developing a proprietary living cell phenotypic cancer testing platform to aid clinical decision-making. The company technology provides quantitative, actionable assessments of individual cancer cells in biopsy samples using multiple phenotypic biochemical and biophysical markers of tumor aggressiveness and metastatic potential.

Cellanyx has demonstrated clinical proof-of-concept with its lead test in development, a test to improve risk stratification in men with prostate cancer.

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Publication:M2 Pharma
Article Type:Clinical report
Date:Nov 23, 2018
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