Cellanyx Publishes Clinical Proof-of-Concept Study of First-in-Class Biomarker Test to Determine Prostate Cancer Risk


Cellanyx and clinical collaborators today 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 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.

“In the study, which analyzed tissue collected from radical prostatectomy specimens, the live tumor cell phenotypic test predicted specific post-surgical adverse pathology features – the gold standard of prostate cancer clinical diagnosis – with a high degree of sensitivity and specificity,” said David Albala, MD, Chief of Urology at Crouse Hospital (Syracuse, NY) and an author on the paper. “Significantly, the test identified subgroups of prostate cancer patients within established low and intermediate Gleason and Prostate Cancer Grading Group (PGGC) tumor grades who had a higher risk based on adverse pathology features, such as positive surgical margins, lymph node involvement, and extra-prostatic extension. These initial clinical results suggest considerable potential of this phenotypic test as a risk stratification tool for prostate cancer patients with low and intermediate grade disease. The results will need to be confirmed in future studies in prostate cancer patients at the time of initial biopsy."

“Tumor heterogeneity and risk stratification are major challenges in the contemporary management of prostate cancer,” said Grannum R Sant, MD, a co-author, Professor of Urology at Tufts University, Chairman of Cellanyx’s SAB and a board member. “This Cellanyx proof of concept study of the first in class, live single cell phenotypic biomarker platform is a major contribution to personalized oncology. If these findings are confirmed in a planned prostate needle biopsy trial, this phenotypic biomarker test will significantly augment Gleason, Grade Group and formalin-fixed tissue genomic analysis in risk stratification of Gleason 6 and Gleason 7 (3+4, 4+3) prostate cancer.”

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.  The Cellanyx live tumor cell phenotypic biomarker platform has the potential for use in a wide range of solid tumors – prostate, breast, kidney, bladder and non-small cell lung cancers.