BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation provided an update on the progress of development of PanC-Dx TM, a novel blood-based diagnostic test utilizing molecular markers discovered at BioTime and OncoCyte designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon. By facilitating early, non-invasive cancer detection, PanC-Dx TM could lead to more successful therapeutic outcomes through earlier diagnosis and treatment. This diagnostic test could also reduce the cost of cancer monitoring and increase the availability of affordable cancer screening worldwide. OncoCyte first announced the development of PanC-Dx TM during December 2011 and last provided a progress update in March 2012. In addition to this update, OncoCyte intends to release additional information regarding the progress of PanC-Dx TM development throughout 2013.
OncoCyte’s plans for 2013 include the initiation of a clinical study focused on breast cancer screening at a group of leading cancer research institutions. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies in preparation for the initiation of the clinical study and is currently working with a select group of cancer researchers to design the trial and select the study sites. If its laboratory findings are validated in clinical trials, PanC-Dx TM may be used as a simple, routine blood test that could be performed in women of any age at any desired frequency to detect breast cancer with as much if not better accuracy and with less cost than a conventional mammogram.
OncoCyte has achieved several key advances in the past year, including:
- Completion of the development and characterization of over 50 proprietary, patent pending, monoclonal antibodies targeting 7 novel cancer antigens. OncoCyte’s findings show a significant elevation of these antigens in the blood of cancer patients when compared to healthy control patients;
- Initiation of validation studies of ELISA assays in order to demonstrate high-sensitivity detection of target antigens using proprietary monoclonal antibodies;
- Completion of large-scale manufacturing of 11 proprietary monoclonal antibodies;
- Initiation of prototype development for a second detection format (solid phase ELISA point of care testing) through a collaborative development agreement; and
- Initiation of clinical trial protocol design analysis in consultation with key opinion leaders and outside diagnostic experts.
Key goals for 2013 will be:
- Completion of validation of our proprietary ELISAs in our patient sample dataset;
- Formalization of additional relationships with key opinion leaders at major medical institutions;
- Institutional review board (IRB) approval and initiation of a large, prospective multicenter patient study at leading breast cancer institutions;
- Presentation of key findings at major oncology-related scientific conferences; and
- Submission of manuscripts to peer-reviewed scientific journals for publication.