BioTime, Inc. (NYSE MKT: BTX) and its subsidiary OncoCyte Corporation today announced that OncoCyte has initiated clinical development of its bladder cancer diagnostic test in both the United States and China. In the United States, OncoCyte has entered into a Clinical Trial Agreement with a leading medical institution with an international reputation for excellence and discovery, while in China, OncoCyte has entered into a Fee-for-Service Agreement with China Medicine Inc., a contract research organization serving nine major medical institutions, including top-ranked university hospitals in Shanghai and Wuhan.
The goal of these clinical studies is the testing of OncoCyte's proprietary diagnostic technology in the most common type of bladder cancer; namely, urothelial carcinoma (UC) (previously designated transitional cell carcinoma). Investigators in the collaborating institutions are collecting urine samples from patients at time of bladder cancer diagnosis as well as from those with a risk for recurrent disease. In certain cases, current standard-of-care diagnostic strategies such as the cellular microscopic analysis of the urine samples will be compared with OncoCyte's proprietary markers. A statistical analysis of these and other results will be performed to determine the overall relative performance of OncoCyte's PanC-Dx™ markers. Completion of these studies is expected by late 2014.
PanC-Dx™ is a class of non-invasive cancer diagnostics based on OncoCyte's proprietary set of cancer markers. These markers were discovered by OncoCyte scientists through an analysis of broad gene expression patterns in numerous cancer types. The markers are the subject of claims in numerous patent applications filed in the United States and abroad, as well as the recently awarded Australian patent entitled "Methods and compositions for the treatment and diagnosis of bladder cancer." 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.
UC constitutes more than 90% of bladder cancers in the Americas, Europe and Asia. Although most patients with bladder cancer can be treated with organ-sparing chemotherapy, UC has a relapse rate of nearly 70% and can progress to invasive, metastatic, and lethal disease. The regular surveillance and treatment of recurrent disease from the time of diagnosis for the remainder of a patient's life makes UC the most costly malignancy on a per patient basis. The problem is amplified because the standard of care for surveillance - microscopic assessment of urinary cytology specimens - often lacks the sensitivity sufficient to ever declare a patient truly disease free. While cytology does have a very high positive predictive value (low false positive rate), it has a low negative predictive value and a high indeterminate rate. Patients who have indeterminate urine cytology results commonly undergo cystoscopy, which is painful, time consuming, costly, and unnecessary in many cases since a neoplasm is often not present. In UC, as in virtually all other cancers, earlier and more accurate diagnosis, including diagnosis of disease recurrence, is generally associated with better outcomes and lower cost.
Overall markets for bladder cancer diagnostics are large and growing. Based on National Cancer Institute statistics released in 2012, it is estimated that in 2013 over 72,000 new cases of bladder cancer would occur in the United States and a total of over 550,000 men and women alive would have a history of bladder cancer and be subject to recurrence surveillance testing using cystoscopy or urine cytology. Based on data released in 2012, the overall incidence of bladder cancer in China is 6.1 cases per 100,000 individuals; a number expected to increase markedly in the next two decades. It is estimated that the annual number of urine cytological analyses performed in the U.S. is over 1.5 million, with more than 3 million tests performed annually in the developed world.
"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. We look forward to working with our clinical investigators in the United States and China, a group that includes key opinion leaders experienced in diagnostic product development, in hopes of developing a superior test for new and recurrent bladder cancer," said Joseph Wagner, PhD, OncoCyte's Chief Executive Officer.