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News Breaks
July 31, 2014
09:03 EDTBTXBioTime unit expands clinical development of bladder cancer test
BioTime and its subsidiary OncoCyte announced that OncoCyte has expanded the clinical development of its urine-based bladder cancer diagnostic test by initiating a multi-site clinical trial. The trial, which will involve up to 1,200 patient samples obtained from at least four large urology clinics located throughout the U.S., has received Institutional Review Board approval at multiple sites and should begin enrolling patients within the next week. OncoCyte’s initial clinical study of its bladder cancer diagnostic test began in January and involves pathology specimens being collected at a leading medical institution with an international reputation for excellence and discovery. The multi-site clinical trial is designed to expand the potential use of the PanC-Dx bladder cancer test beyond pathology laboratories and into urologic practices at the point of cystoscopy. Cystoscopy along with urine cytopathology, are the standard methods utilized for bladder cancer screening and diagnosis. The multi-site clinical trial should be completed within 12 months. The goal of the current clinical trial is to compare the performance of OncoCyte’s proprietary PanC-Dx bladder cancer markers to the performance of cystoscopy.
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December 15, 2014
12:01 EDTBTXBioTime unit, GE Healthcare sign set of license agreements, terms not disclosed
BioTime (BTX) announced that its subsidiary ES Cell International Pte. Ltd. and GE Healthcare (GE) have signed a set of license agreements through which GEHC received rights to ESI’s stem cell patents and ESI received rights to stem cell patents controlled by GEHC, in both cases for the development of cellular assays and models derived from stem cells for use in drug discovery and toxicity screening. In addition, the agreements give GEHC the right to grant sub-licenses to the ESI patent portfolio and, in certain circumstances, ESI may further sublicense its rights for the purpose of marketing stem cell-derived products. Financial terms were not disclosed.
11:01 EDTBTXBioTime completes initial enrollment of urine-based bladder cancer test trial
BioTime and its subsidiary OncoCyte Corporation announced that OncoCyte has completed enrollment in the initial clinical study of its urine-based bladder cancer diagnostic test. The study, which involved 100 patients, was conducted in collaboration with investigators in the Department of Pathology, Division of Cytopathology, at a leading medical institution with an international reputation for excellence and discovery. Initial results of the study have been submitted for presentation at a large upcoming cancer society meeting; eventual publication of the final results in a peer-reviewed clinical journal is also anticipated. 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. 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.
December 12, 2014
14:52 EDTBTXBioTime to host investor and analyst meeting
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