A novel diagnostic device is being developed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups.
OncoCyte Corp. (Alameda, CA, USA) a subsidiary of BioTime, Inc. (Alameda, CA) has plans to develop the novel pan-cancer diagnostic product PanC-Dx, to detect the presence of various human cancers. The product would require only a simple antibody-based blood test similar to that commonly used to screen for prostate cancer.
PanC-Dx may be useful for detecting a much wider range of cancer types than that detected by blood tests currently available to clinicians. By facilitating early noninvasive detection, it could lead to more successful therapeutic outcomes while reducing the costs of cancer monitoring and increasing the availability of affordable cancer screening worldwide.
BioTime developed novel methods of accurately determining the pattern of over 40,000 gene sequences expressed in diverse types of cells arising from embryonic stem cells and induced pluripotent stem cells. Working together, BioTime and OncoCyte scientists discovered a large number of altered genes that appear to be associated with cancer.
The patterns of the proteins produced from a subset of these genes could be detected in the blood of cancer patients, but not in the blood of healthy people. The test’s specificity was higher than that of commonly used tests such as the prostate-specific antigen test for prostate cancer.
BioTime and OncoCyte want to commercialize rapidly the PanC-Dx. The goal is to launch PanC-Dx in Europe in 2013. A blood-screening test for cancer markers meets the definition of an in vitro diagnostic product as defined in the European Directive on in vitro diagnostic medical devices (IVD). Under this directive, IVD products placed into the European market must bear the CE mark, which indicates the product is in conformity with all applicable requirements of safety, performance, instructions, markings, and quality sufficient for the safe and effective use of the product. PanC-Dx is classified as a General IVD under this directive.
Joseph Wagner, PhD, CEO of OncoCyte, said, “Our initial evidence of high sensitivity and specificity of the product, our aggressive filing for patent protection, the great unmet need in the field, and the tie-in of the molecules used in the diagnostic product with our stem cell-based therapeutic strategy give us an ideal “theragnostic” model under which we are codeveloping a diagnostic and an associated therapeutic that hinge on the same biology. All these factors led to our choice of PanC-Dx as OncoCyte’s lead diagnostic product.”