Products

StromaGenesis has developed three products aimed at transforming cancer diagnostics and personalized treatment strategies:

ProstaGene


A tissue-based QRT-PCR diagnostic that analyzes the expression of 14 genes using a proprietary algorithm to improve risk stratification and recurrence prediction for prostate cancer. It is designed as a Laboratory-Developed Test (“LDT”), with CLIA certification in progress and in silico clinical trials already completed. The test has the potential to expand into a non-invasive urine-based version. With an estimated global market opportunity of approximately $1 billion, the underlying gene panel and algorithm are protected as trade secrets.

CCR5 Companion Diagnostic

A blood-based immunoassay detecting CCR5 expression in circulating tumor cells and tumor tissue to identify patients most likely to respond to CCR5-targeted therapies. It functions as a companion diagnostic for multiple solid tumors, including breast, colon, prostate, and pancreatic cancers. The platform has completed a Phase 1B/2 clinical trial and targets an estimated $2 billion global market. It is protected by granted patents and claims in the U.S., Canada, and Japan, with additional applications filed to expand coverage.

StromaGenesis

A tissue-based immunohistochemistry assay that assesses biomarkers in the tumor microenvironment to predict therapy response across multiple solid tumors. It supports both diagnostic and prognostic applications in indications such as breast, colon, prostate, and glioblastoma. The platform has completed Phase 1B/2 clinical trials and has been validated in over 10 independent clinical studies.

Intellectual property protection includes granted patents in France, Germany, and the UK, with global expansion underway through Patent Cooperation Treaty (“PCT”) filings. The estimated global market potential is approximately $600 million.

These products address large global markets, are supported by strong intellectual property, and have demonstrated strong clinical promise across various stages of development.