Cellanyx’s First-in-Class Prostate Test
Tumor cells act differently than normal cells. The Cellanyx test is the first to assess prostate cancer risk based on phenotype, the behavior of live tumor cells obtained from a patient biopsy. The test is designed augment Gleason testing and provide an actionable, quantitative score to measure likelihood that individual’s risk that a tumor is aggressive or not.
In a proof-of-concept study, published in the journal Urology, the test predicted specific post-surgical adverse pathology features – the gold standard of prostate cancer clinical diagnosis – with a high degree of sensitivity and specificity. 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 predictions of specific adverse pathology features based on the Cellanyx test were then compared to the actual post-surgical pathology reported findings following data un-blinding.
Based on the initial success with the proof-of-concept study, Cellanyx plans to conduct a prospective clinical study in prostate cancer patients at the time of needle biopsy to evaluate its ability to predict adverse pathology at the time of surgery. The study is designed to demonstrate the test’s clinical utility and will provide the basis for commercialization of the LDT.
Cellanyx’s LDT will be used in conjunction with the prostate pathology Gleason scoring test. The Cellanyx test, which delivers a result in three days, integrates with the workflows of both urologists and testing laboratories. The Company is exploring the potential for commercializing the test through the FDA 510(k) regulatory pathway.