Positive Results From Clinical Study Designed To Evaluate Efficacy Of Circulating Tumor Cell Detection With Ikonisys' Automated Microscope

Main Category: Breast Cancer
Also Included In: Medical Devices / Diagnostics
Article Date: 16 Oct 2008 - 1:00 PDT

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Ikonisys, a leading provider of next-generation, cell-based diagnostic solutions, today announced positive results from a clinical study conducted by a research group at the Weatherall Institute of Molecular Medicine at Oxford University, a laboratory supported by Cancer Research U.K. (CRUK), the country's leading cancer charity. The study validates the company's CellOptics® platform and proprietary digital microscope, the Ikoniscope®, as a viable method for quickly and easily detecting and detailing circulating tumor cells (CTC) in the blood. The findings, published in the British Journal of Cancer (September 2008), represent a significant milestone for screening and disease monitoring for a variety of cancers, including prostate, colorectal and ovarian.

Led by world-renowned scientist, Sir Walter Bodmer, the study demonstrates the importance of CTC detection in providing a new and effective approach to the overall management of cancer. The study analyzed blood samples from several patients with prostate, colorectal and ovarian cancer. The blood samples were analyzed using the Ikoniscope, a fully-automated, fluorescence microscopy imaging system. CTCs were detected in 23 of 25 colorectal, 10 of 10 prostate and four of four ovarian cancer patients. Overall, study results show that CTCs could be used for early cancer screening, detection of recurrence and evaluation of response to therapy.

"I am very excited about the possibilities of this technology both for monitoring cancer recurrence and for screening for selected cancers," said lead author Sir Walter Bodmer, director of the Cancer and Immunogenetics Laboratory, Weatherall Institute of Molecular Medicine, Oxford University. "The application could be particularly valuable in preventing an excess of false positives in PSA testing."

"We are very pleased with the results of the study and the impact they have on our goal of improving current screening methods for cancer detection," said Dr. Petros Tsipouras, Ikonisys CEO and chairman. "Given the recent recommendation to stop routine prostate cancer screening in men aged 75 and older, the results are especially exciting as they suggest this method may be an effective way to increase the number of positive biopsies based on elevated PSA levels. This new method of detecting CTCs shows great promise in our continuous quest to provide physicians and patients with early, accurate screening methods that ultimately enable personalized medical treatments."

Through its breakthrough CellOptics platform, Ikonisys is developing a stream of proprietary and non-proprietary tests based on the detection of rare cells in a practical, efficient and economical manner. At the center of the platform is the Ikoniscope, a robotic, high-throughput, image acquisition and display microscopy system that is used for rare cell detection and analysis in an entirely digital environment, helping lab technicians to find the few cells out of millions that matter. In addition to simply presenting cell images to the lab technician, the platform analyzes the cells, offering an interpretation of the progression, while simultaneously allowing the pathologist to concur or override the analysis. This intelligent technology is ultimately laying the groundwork for a "virtual digital assistant" to the pathologist.

About Ikonisys

Ikonisys is changing the practice of diagnostic medicine through its unique CellOptics platform - an innovative combination of intelligent imaging, microscopy, biology and informatics - that enables Ikonisys to deliver diagnostic test solutions that are automated, innovative and integrated. By providing "walk away" automation solutions, Ikonisys enables reference labs, hospitals, research institutions and practice groups to both greatly expand their test volume capacity and standardize their diagnostic procedures. This will further enhance their ability to economically deliver accurate, fast and personalized results for early cancer diagnosis and monitoring, and genetic disorder screening to physicians and researchers.

In addition to automating existing FISH-based tests, the CellOptics platform enables Ikonisys to launch a stream of next-generation diagnostic tests that are based on the detection of rare cells in a practical, efficient and economical manner. These "signature" tests will include proprietary test specific reagents. The integration capabilities of the CellOptics platform provides for both the transfer of patient test data into a laboratory's information systems - enabling the creation of more comprehensive patient medical records - as well as the potential to utilize these novel tests as companion diagnostics, which provides a path to fully realize the promise of personalized medicine.

In 2006, Ikonisys obtained FDA clearance for fastFISH® amnio, an imaging application for the Ikoniscope that provides automated identification of numerical aberrations of chromosomes associated with common birth defects. Additionally, in early 2007, the company received FDA clearance for oncoFISH® bladder, an Ikoniscope application that helps in the initial diagnosis of bladder cancer. http://www.ikonisys.com

About the British Journal of Cancer

The BJC is owned by Cancer Research UK. Its mission is to encourage communication of the very best cancer research from laboratories and clinics in all countries. Broad coverage, its editorial independence and consistent high standards have made BJC one of the world's premier general cancer journals. http://www.bjcancer.com.