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GeneCentric Begins Study to Validate RNA Gene Signature Test in Bladder Cancer

NEW YORK – GeneCentric Therapeutics on Wednesday said it has launched a real-world study in collaboration with researchers at Memorial Sloan Kettering Cancer Center and the University of Wisconsin-Madison Carbone Cancer Center to validate its FGFR predictive response signature (FGFR-PRS) in bladder cancer patients.

The FGFR-PRS is a multi-gene RNA expression test designed to identify a larger population of patients who could benefit from FGFR-targeted therapies than currently available tests. GeneCentric is developing the FGFR-PRS test in partnership with Labcorp.

In the study, dubbed Alamance, investigators will collect tumor samples and clinical response data from about 250 patients with locally advanced or metastatic urothelial cancer who have been treated with FGFR-targeted therapy or another standard-of-care therapy. Clinicogenomic data obtained from the study will be analyzed using GeneCentric's RNA-based Tumor and Immune Micro-Environment (rTIME) explorer platform.

"While there has been significant progress in developing new treatment options for patients with locally advanced or metastatic bladder cancer, there remains a need for better predictive biomarkers and tests that can inform the optimal treatment for individual patients," Gopa Iyer, section head of urothelial cancer at Memorial Sloan Kettering, said in a statement. "Data from the Alamance study will be invaluable in this endeavor, especially with regard to developing novel tests to guide the use of FGFR-targeted and other therapies."

Durham, North Carolina-based GeneCentric partnered with Janssen in 2020 to identify potential signatures of disease progression and drug response, including genomic alterations in FGFR, in non-muscle invasive bladder cancer using GeneCentric's RNA-based tumor bioinformatics technology.