Xceed Molecular Signs University of Florida to Strategic Collaborator Program; Focus on Developing New Molecular Test to Diagnose Early-Stage Bladder Cancer

Xceed Molecular, a pioneer in the development of cost effective, easy-to-use gene-expression analysis systems, announced that the University of Florida has joined Xceed’s Strategic Collaborator program. Xceed will work with primary researchers, Charles Joel Rosser, MD (Department of Urology) and Steve Goodison, MD (Department of Surgery), to perform initial verification and validation of an expression signature that has shown promise as a way to differentiate bladder cancer from other conditions using voided urine samples.

As part of the collaboration, Xceed and the University of Florida will test approximately 700 samples from patients previously identified to have either cancerous or non-cancerous bladder tumors to verify that the expression signature is useful in distinguishing the two populations. Xceed will run the first 100 samples on the company’s Ziplex^® System in its expression-services laboratories in Toronto to optimize the performance of the signature on the Ziplex platform. The company will also provide a Ziplex System to the university, where the study on the remaining samples will be completed. If the signature is successfully validated, Xceed and the University of Florida will continue to work together to pursue subsequent clinical testing to validate the signature for use in patient management. Specific terms were not disclosed.

Nearly 70,000 Americans are diagnosed with bladder cancer every year. The symptoms, voiding problems and/or blood in the urine, are common to many other health issues (e.g. urinary tract infections, kidney stones, trauma). Today, bladder cancer is diagnosed and monitored with cystoscopy – an invasive, uncomfortable, and costly procedure in which a scope is inserted through the urethra to visualize the bladder. Suspicious areas are biopsied and sent to the pathology lab. The skill of the doctor performing the procedure is of paramount importance – low-grade and low-stage tumors can be easily missed. Too often, cancer is not diagnosed until after it has had a chance to progress. Nearly 14,000 Americans die annually from the disease.

“We are honored to work with the University of Florida on this important effort to find an earlier, more effective way to diagnose and monitor this devastating disease,” said Xceed President and CEO, David Deems. “Dr. Rosser and Dr. Goodison are the ideal collaborators, with the necessary experience to evaluate the potential of the signature to improve patient management.”

Commenting on the collaboration, Dr. Rosser said, “We are excited to be developing our bladder cancer assay on Xceed’s Ziplex System. It offers the first chance for us to perform our validation studies on a platform that is easy to use, cost-effective, and well suited for the clinical lab. The medical community has been looking for a better way to diagnose and monitor the disease. Seventy to 80 percent of bladder tumors are superficial, but 60 to 70 percent of these tumors will reoccur, and 20 to 30 percent will progress to a higher grade or stage – so regular, aggressive surveillance is required. The current protocol calls for cystoscopy every three months for two years after diagnosis, followed by every six months for two years, followed by cystoscopy yearly. If we are successful in developing a urine assay to test for bladder cancer, it would not only potentially save lives, but would also reduce the need for frequent cystoscopies – a welcome change to improve patients’ quality of life.”