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Ikonisys Introduces Rare-Cell Test Designed to Determine Early Progression to Cervical Cancer

September 22, 2008

Ikonisys, a leading provider of next-generation, cell-based diagnostic solutions, announced today the launch of its clinically-validated, novel cervical cancer test, oncoFISH(R) cervical. Used in conjunction with the company’s proprietary CellOptics(R) platform, a robotic microscopy system, oncoFISH cervical provides the physician, while still adhering to current practice guidelines, with an assessment of risk of progression of low grade dysplasia to cancer of the cervix. oncoFISH cervical will be offered as a laboratory developed test through Ikonisys’ licensed CAP-accredited Clinical Laboratory.

According to the American Cancer Society, cervical cancer is the second most common form of cancer in women in the world, affecting more than 500,000 women yearly. While the traditional Pap smear has helped to decrease substantially the cervical cancer death rate, a significant number of women with cervical dysplasia still develop cervical cancer, resulting in 11,000 newly diagnosed cases and 5,000 deaths in the United States each year, thus making additional cervical screening methods critical. oncoFISH cervical is the first to work in conjunction with currently used screening tests like the Pap smear and HPV as a differentiator for medical professionals seeking to identify which patients may regress or progress to cervical cancer. Based on this information, physicians and patients can work together to develop early, personalized treatment plans that aim to better address individual needs and ultimately increase chances of survival.

“We are very pleased to introduce our first rare-cell based test, supported by Ikonisys’ proprietary CellOptics platform, the foundation for all of our next-generation diagnostic tests,” said Dr. Petros Tsipouras, Ikonisys CEO and chairman. “Through our novel tests and unique ability to provide intelligent, digital pathology, Ikonisys is undoubtedly advancing the practice of medicine. Not only are we providing patients and physicians early and accurate detection, but we’re helping them to realize the promise of personalized medicine by enabling practitioners to provide the appropriate treatment based on individual risk.”

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. In addition to simply presenting cell images to the laboratory technologist, the platform analyzes the cells, offering an interpretation, while simultaneously allowing the pathologist to concur or override the analysis. Ikonisys will be initiating clinical trials on oncoFISH cervical for Food and Drug Administration (FDA) clearance.

For more information on Ikonisys’ oncoFISH cervical, please visit www.ikonisys.com.

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(R) amnio, an imaging application for the Ikoniscope(R) 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.




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