SOURCE: Mount Sinai Services, Inc.

Mount Sinai Services, Inc.

July 19, 2016 09:00 ET

Novel Molecular-Based Precision Diagnostic for Bladder Cancer Now Available; Next Generation Sequencing Is Set to Improve Tumour Classification

TORONTO, ON--(Marketwired - July 19, 2016) - Launching today, a groundbreaking precision diagnostic tool will help classify the aggressiveness of non-muscle invasive bladder tumours, announced Mount Sinai Services of Toronto, a global provider of customized clinical laboratory and research services. The new technology is marketed by iTP Biomedica as BladderPredict™, and is the first of a series of proprietary next generation sequencing diagnostic tests resulting from collaborative work at the Lunenfeld-Tanenbaum Research Institute and Mount Sinai Services.

The new technology reduces diagnostic subjectivity, providing clinicians with a higher degree of certainty regarding disease type and allowing for more evidence-based point of care treatment. The unique strategy measures the entire output of the human genome, providing a more holistic and reliable evaluation of tissue biopsies than conventional tests, which rely on more narrow sequencing methodologies.

"The current course of treatment for bladder cancer is often selected based upon presumed prognosis of the disease type, which is determined by the microscopic appearance of the tumor cells; however these are presumed and many tumors may appear identical under the microscope but behave dramatically differently," says Mount Sinai Hospital surgeon Dr. Alexandre Zlotta, who leads the hospital's Bladder Cancer Research Program. "Because bladder cancer has a variable course with tumors behaving in very different ways, quite often we treat either too aggressively, or not aggressively enough."

By contrast, BladderPredict provides both an objective molecular fingerprint of the tumour grade to inform the clinicians' judgment, and the potential clinical trajectory of disease.

Research supporting the technology has already been well received by the academic and clinical communities. In recent years, findings related to the development of the test were published in the scientific journal European Urology and presented at major scientific meetings, namely the ASCO GU (American Society of Clinical Oncology), EAU (European Association of Urology) and AUA (American Urological Association).

The BladderPredict tool is the first of many similar proprietary precision diagnostic tests to assist clinicians and researchers in the area of cancer care. The tests are being developed and validated in collaboration with Mount Sinai Hospital's Lunenfeld-Tanenbaum Research Institute, one of the leading research institutes in the world, and Mount Sinai Services. These tests are being commercialized by iTP Biomedica with the operational support of Mount Sinai Services, a CAP/CLIA and ISO certified laboratory. Bladder cancer, which is the 4th leading cause of cancer in men, and 6th overall, is the most expensive to treat, and was selected as a lead disease due to the current paucity of related molecular diagnostic procedures.

"We are extremely pleased to be the team that introduces the BladderPredict test to clinicians and patients. We are confident that BladderPredict will greatly assist practitioners in treating patients who are faced with such a difficult disease," said Dr. Ken Hughes, iTP Biomedica's CEO. "This is an important milestone for the company as it exemplifies our overarching technology platform by showing a clear clinical application. In the coming months we will be applying our approach to multiple cancers and other diseases in our pipeline."

"We believe this is the future of cancer diagnostics and prognostics," says lead researcher and Lunenfeld-Tanenbaum Research Institute scientist, Dr. Jeff Wrana. "Especially because very little is known about bladder cancer and with these technologies we can probe the functions of genes and their protein products. We can also assess how genes might be mutated or rearranged in cancer."

The availability of BladderPredict will not only help clinicians and their patients in making treatment decisions, but also enable more comprehensive, insightful and cost-effective studies to be managed by the research community. It will also provide better pre-trial screening and ongoing measurement of subject response to treatment.

About Bladder Cancer
An estimated 85,000 North Americans are diagnosed with bladder cancer each year. Although less common in women, it is the fourth most common cancer in men. Because of an 80 per cent recurrence rate, bladder cancer is also the most expensive cancer to treat on a per-patient basis. Despite progress in other areas of cancer treatment, five year survival rates of bladder cancer have not shown any improvement in recent history.

A key obstacle to improving outcomes in bladder cancer is the difficulty in securing reliable diagnoses regarding tumour stage and grade. Highly experienced pathologists may still arrive at separate conclusions about the grade of the same tumour biopsy. In fact, case studies have demonstrated that different pathologists examining the same biopsy may disagree on tumour grade in up to 40 per cent of cases. Since tumour grade is a critical data point to be used in providing effective patient care, this lack of diagnostic insight has frustrated clinicians' efforts to manage the disease.

About Mount Sinai Services, Inc.
Mount Sinai Services is a CAP/CLIA and ISO 15189 certified global provider of customized clinical diagnostic laboratory and research services. Mount Sinai Services works closely with world-renowned clinicians and researchers at Sinai Health System, Lunenfeld-Tanenbaum Research Institute, University of Toronto and other Canadian academic and healthcare providers to offer comprehensive services supporting discovery and innovation in the life sciences, including medical device and diagnostic assay development and validation, clinical trial management and providing customized services to biotech and pharma industry. Mount Sinai Services provides specialized clinical laboratory testing throughout Canada and supports processes to achieve new assay reimbursements. Mount Sinai Services is committed to providing its clients with superior customer service and high-quality results based on a truly collaborative approach. For information, visit www.mountsinaiservices.com.

About iTP Biomedica
iTP Biomedica Corporation ("integrated Transcriptomics for Personalized medicine") is a Toronto-based company founded to commercialize unique technology developed at Mount Sinai Hospital's Lunenfeld-Tanenbaum Research Institute. This proprietary whole-genome technology platform is positioned to supersede other molecular approaches to diagnosis/prognosis that have recently been commercialized. Current tests depend on limited numbers of marker genes to predict the behaviour of complex diseases, and therefore are prone to false positive and false negative results. By contrast, iTP Biomedica delivers a functional readout of the entire human genome and its Next-Gen Transcriptomic platform, incorporating a fully-developed Quality System, efficiently handles massive bioinformatics data sets to allow rapid development and commercialization of exquisitely accurate tests for cancer and other diseases. iTP's lead products are diagnostic/prognostics for bladder cancer progression, with pipeline products for prostate cancer and breast cancer to follow. The company is also developing a portfolio of blood and urine-based diagnostic tests as part of its R&D pipeline and is oriented to collaborative co-diagnostics development. For information, visit http://www.itpbiomedica.com/

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