Ramat Gan, Israel, February 9th, 2009 - "Zetiq Technologies", a subsidiary of Bio-Light Ltd (TASE: BOLT), reports the successful completion of a clinical trial, aimed at identifying and diagnosing bladder cancer in biopsies via Zetiq's proprietary CellDetect® technology. The goal of the trial was to demonstrate and measure the ability of the CellDetect® technology to accurately diagnose the presence of bladder cancer cells and the stage of the disease, in bladder biopsies.
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.
"We are excited by having successfully completed this important milestone which demonstrates the company's ability to develop a simple and effective diagnostic tool for early identification of bladder cancer", says Dr. Adi Elkeles, CEO of Zetiq Technologies Ltd. "We are bringing forth a powerful tool for dual analysis of color and morphology to the bladder cancer setting. Alongside our previous positive clinical data on diagnosis of cervical cancer, these results prove our long standing statement that the CellDetect® technology has the ability to identify a broad range of cancer indications, and augments our well published pre-clinical findings", adds Dr. Elkeles.
Zetiq's technology, known as CellDetect®, uses dual analysis of both color discrimination and morphological analysis to differentiate between neoplastic and non neoplastic cells.
Bladder cancer is one of the most commonly occurring cancers in the world. In the US, bladder cancer is the fifth most common neoplasm and the 12th leading cause of cancer death, with over 70,000 annual new identified cases of bladder cancer and over 14,000 annual deaths as a result of this disease. It is estimated that over 500,000 patients in the U.S. and over two million patients worldwide are living with bladder cancer. Males are affected four times more frequently than women. The overall 5-year relative survival rate is 97% when the disease is identified at its earliest in situ stage, and drops to 6% when the disease is diagnosed at its distant stage, stressing the importance of early diagnosis.
No effective screening technique is available for detection of bladder cancer. Moreover, bladder cancer has the highest rate of recurrence among all US malignancies (over 75%), and there exists a high demand for effective monitoring programs.
Dr. Ami Eyal – Medical Director of Zetiq and CEO of Bio-light, its parent company says: "The CellDetect® technologies' ability to detect cancer cells is exceptional. These findings attest to the range of applications for the company's technology and open the door for expanding our efforts to develop diagnostic tools for additional cancer indications. The results of this trial confirm that Zetiq has the potential to develop novel and effective products for early diagnosis of bladder cancer alongside cervical cancer, and other indications. The company plans to further develop products for early diagnosis, and monitoring, of bladder cancer."
Zetiq is a subsidiary of Bio-Light Life Science Investments, a management and holding company specializing in biomedical technologies. Bio-Light is traded on the Tel Aviv Stock Exchange under the symbol TASE:BOLT.
About Zetiq:
Zetiq Technologies Ltd. develops effective cancer diagnostic tools. There is a significant medical need for early stage diagnostic tools for screening, monitoring or diagnosing cancer. Zetiq offers unique advantages in this market with its proprietary CellDetect® technology for differential staining and morphological visualization to differentiate between non cancer cells and a wide variety of cancer indications. The Company's products alleviate the process of locating and identifying suspected cancer cells, reduce error, simplify the process and have a potential to be fully automated.
Zetiq is a subsidiary of Bio-Light Life Science Investments, a management and holding company specializing in biomedical technologies. Bio-Light is traded on the Tel Aviv Stock Exchange under the symbol TASE: BOLT.
