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-OncoCyte’s Proprietary Diagnostic Markers Tested on Patient Samples Collected by Pathologists at
The goal of this clinical study was to assess the performance of OncoCyte’s proprietary diagnostic technology in detecting the most common type of bladder cancer; namely, urothelial carcinoma (UC) (previously designated transitional cell carcinoma). Study investigators collected urine samples from patients undergoing urine cytology for the diagnosis of either primary or recurrent bladder cancer. Patient urine samples were assessed microscopically for the presence of cancer cells using the current standard-of-care method of cytopathology; in parallel, OncoCyte scientists analyzed the remaining portion of the urine samples for gene expression, including expression of OncoCyte’s proprietary PanC-Dx™ markers. In some cases, the quality of the residual urine sample provided to OncoCyte did not allow for a valid analysis; in these cases additional replacement samples will be provided. A statistical analysis was performed and a panel of markers that discriminates UC from non-cancerous conditions was identified. The ability of the markers tested in the studies to determine the absence, presence, or progression of UC in patients will determine the specific nature of the bladder cancer test to be developed and the regulatory approval pathway that OncoCyte will pursue.
“There is a large and growing need for more sensitive, cost-effective, and less invasive methods to detect and monitor cancer in humans, particularly in bladder cancer. The completion of enrollment in this clinical study represents a major milestone in our efforts to develop a urine-based bladder cancer diagnostic. Importantly, the study not only was completed in the projected time frame but also the results to date have exceeded our expectations in terms of our diagnostic test performance. We are currently validating the results of this study in a larger prospective trial that will enroll up to 1400 patients. The larger study was initiated in July and has already enrolled over 300 patients at four sites; we are currently recruiting additional sites and plan on completing the study in 2015,” said
Urothelial carcinoma (UC) constitutes more than 90% of bladder cancers in the
Overall markets for bladder cancer diagnostics are large and growing. Based on
OncoCyte, a majority-owned subsidiary of
Asterias Biotherapeutics, Inc. is developing pluripotent stem-cell based therapies in neurology and oncology, including AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based cancer vaccine. Asterias Series A common stock is traded on the NYSEMKT under the symbol AST. BioTime Asia, Ltd., a Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division.
- Cell Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders. OpRegen™ is currently in a Phase I/IIa clinical trial for the treatment of the dry-form of age-related macular degeneration. ESI BIOis the research and product marketing division of BioTime, providing stem cell researchers with products and technologies to enable them to translate their work into the clinic, including PureStem® progenitors and HyStem® hydrogels.
- LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery® database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database.
- LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on developing mobile health (mHealth) products.
- OncoCyte Corporation is developing products and technologies to diagnose and treat cancer, including PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing therapies to treat orthopedic disorders, diseases and injuries.
- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of cardiovascular and related ischemic disorders, as well as products for research using cell reprogramming technology.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for
To receive ongoing
Judith Segall, 510-521-3390 ext. 301
EVC Group, Inc.
Michael Polyviou, 212-850-6020
Gregory Gin, 862-236-0673
Doug Sherk, 415-652-9100