Cellanyx, a Massachusetts-based diagnostic company, has developed proprietary live tumor cell phenotypic biomarker tests to improve cancer risk-stratification and allow informed clinical decision making. Their unique approach provides quantitative and actionable information based on analysis of thousands of live tumor cells. The tests employ a microfluidic platform combined with machine vision and machine learning approaches to analyze phenotypic morphological, biochemical and biophysical markers.
Cellanyx has demonstrated initial clinical proof-of-concept with its lead phenotypic test in prostate cancer. The initial clinical proof-of-concept study was conducted to demonstrate improved risk stratification in men with low and intermediate Gleason grade (6 and 7) disease and reduce the number of repeat biopsies. Furthermore, analysis of “field” samples (away from the suspicious core) demonstrated the potential value of Cellanyx phenotypic test as it was able to analyze the tumor microenvironment conditions and predict expected adverse pathology from samples that were not taken from the suspicious core. These new findings from the Cellanyx prostate test are transformative as it will reduce the errors in diagnosing cancers early due to sampling heterogeneity of prostate biopsies.
There is a need for precision within the world of prostate cancer diagnostics. As the company states on their website, lack of clinical tools for more precise individualized risk stratification results in significant over-diagnosis and overtreatment of low/intermediate Gleason 6 and 7 prostate cancer, the need for repeat biopsies with resultant reduced quality of life, and increased healthcare costs for treatment of prostate cancer. Additionally, precision tools are needed to identify aggressive low/intermediate prostate cancer thereby reducing the risk of under-treatment.
With biopsies to detect prostate cancer sampling less than one percent of the prostate gland, one-half of approximately 1.3 million initial prostate biopsies are negative. This leads to the need for re-biopsy in a significant percentage of men. Prostate cancer is then detected in approximately 80 percent of such re-biopsied patients, representing an unmet need and a market opportunity for a supplementary, albeit simultaneous or contemporaneous test, to augment the conventional pathological evaluation.