Jun 24 2010
Zetiq Technologies Ltd. ("Zetiq"), a subsidiary of Bio-Light Ltd. (TASE: BOLT), reports the successful completion of another clinical trial to validate the effectiveness of the company's technology for early identification and diagnosis of cervical cancer, in conventional cytological smears.
“The practical significance of these findings shows that we have a tool for cervical cancer diagnosis, a field with a WW market size of above $3 Billion, which is more accurate and substantially cost effective as compared to the tests currently used.”
In this trial, conducted in parallel in Israel and in the National Institute of Oncology in Hungary, conventional cytological smear samples were collected from 68 subjects undergoing clinical evaluation for cervical cancer diagnosis, without processing such as liquid based preparations, commonly used today in cervical cytology. The collected samples were examined in 3 methods: staining with the traditional widely used Pap method, testing to identify the presence of the HPV virus that causes the disease (HPV typing), and the CellDetect® technology developed by Zetiq. Specimen analysis was conducted by the company's team as well as by an independent professional.
The results of this experiment confirm the previous successful experiments performed by the company in which identification of cervical cancer was gouged using histological samples as well as liquid based cytological samples (ThinPrep™), showing that the CellDetect® technology offers superior diagnosis of the disease.
The trial results demonstrate that testing utilizing the company's CellDetect® technology had an average sensitivity of 94% in identifying early dysplasia, 97% sensitivity in identifying moderate to severe dysplasia, and 100% in diagnosing Squamous Cell Carcinoma. The specificity of the CellDetect® test was found to be 85%.
The sensitivity of the CellDetect® test was found to be greater than that achieved by the comparative tests examined. In this trial, the average sensitivity for identifying early dysplasia was found to be 81% for the Pap test and 80% for HPV typing; the average sensitivity towards identifying moderate to severe dysplasia was found to be 82% for the Pap test and 92% for HPV typing; and 100% sensitivity for diagnosing Squamous Cell Carcinoma in the Pap test. The specificity of CellDetect® was found to be similar to that of the Pap test (85%), and much higher then that of HPV typing (41%).
Dr. Adi Elkeles, CEO of Zetiq Technologies Ltd says: "The practical significance of these findings shows that we have a tool for cervical cancer diagnosis, a field with a WW market size of above $3 Billion, which is more accurate and substantially cost effective as compared to the tests currently used."
"The results of this trial indicate that the CellDetect® technology developed by Zetiq is more efficient in the main parameters tested, above the current available tests. Considering the fact that the product developed by Zetiq is also cheaper, we believe that we have the basis for a superior product," adds Dr. Elkeles.
Cervical cancer is the second leading cause of cancer in women world wide. Early identification of the disease greatly increases the survival rate.
The screening methods currently available for the disease have succeeded in reducing mortality rate in the Western world, where performed, but their error rate is high and the cost of follow up tests is substantial. To note, the error rates of the Pap test in screening reach 30-50%.
Screen tests for cervical cancer are performed routinely in the western world, and in spite of their draw backs have a large market that in the US alone reaches above 1.5 Billion dollars. In developing countries, that have 80% of the WW newly identified cervical cancer, there is no effective screening test available today to identify cervical cancer.
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