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.
Cellanyx reported positive results from the risk stratification study, designed to offer a new tool to help in clinical decision making for patient care.
The study was conducted at multiple centers, 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 at a central laboratory where they were tested, on a specially coated microfluidic chip and analyzed 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 is claimed to have accurately predict post-radical prostatectomy adverse pathology features with an area under the curve (AUC) 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).
American Cancer Society reported that prostate cancer is considered to be one of the most common cancers for men in the US, with an estimated 164,690 new cases diagnosed this year. Although, most men do not die from this cancer, yet an estimated 39,430 deaths from the cancer have been estimated for this year.
Current tests are unable to provide risk stratification of aggressive disease in low and intermediate grade patients leads to missed diagnoses, and inadequate treatment.
Scientific Advisory Board member Albala Cellanyx said: “Risk stratification in prostate cancer – distinguishing clinically significant cancer from indolent disease – remains a major challenge in men with low and intermediate grade disease.
“A subset of these patients may develop aggressive disease and we currently lack sufficiently precise, personalized risk stratification tools to distinguish between indolent and potentially aggressive disease.”
This live single cell phenotypic biomarker test is being developed as a Laboratory Developed Test that can be run in any CLIA laboratory.