Zetiq Reports Success in Clinical Trial for Identification of Bladder Cancer
The study's goal was to validate the ability of the CellDetect® technology to correctly identify bladder cancer by means of its dual analysis features which include differential staining alongside morphological visualization. The study reviewed 58 biopsy samples obtained from the archive of "Rabin MC" in Israel which were selected by an unrelated party. The study included Biopsy samples with no previously identified abnormal findings (control group) as well as two study groups containing biopsy samples from identified bladder cancer cases, at different severity disease stages. Histological samples were prepared from each case, where one sample was processed by the CellDetect® technology while another slide was stained by the H&E method, the current gold standard stain for identifying bladder cancer. Diagnosis of each sample was performed independently by two expert pathologists.
The study results demonstrated a perfect (100%) correlation between the CellDetect® technology based diagnosis, and the diagnosis made upon H&E staining, obtained from each pathologist. The CellDetect® technology showed distinct morphological features in addition to the powerful differential staining, which showed a high correlation with the morphological features. In certain cases, suspected pre cancer regions were identified in the control study group. In these cases, the CellDetect® technology showed the correct differential staining, which aided the identification of subtle morphological changes, findings that were strengthened by an independent secondary stain examination. As said, in all the examined cases, the CellDetect® technology was found to correctly identify, in comparison to the current gold standard, both the disease and the disease stage.
On the basis of the positive results, Zetiq intends to pursue the development of products for monitoring and diagnosing bladder cancer.
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