Ikonisys Receives FDA Clearance For Non-Invasive, HER-2 Breast Cancer Test

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 29 Oct 2008 - 9:00 PDT

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Ikonisys, a leading provider of next generation, non-invasive, cell-based diagnostic solutions, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its oncoFISH her2 test. oncoFISH her2 is a fully automated microscopy application for the determination of HER2 status in human breast cancer specimens processed with Abbott's PathVysion® HER2 DNA Probe Kit. The test runs on the company's proprietary CellOptics® platform, featuring the Ikoniscope®, a proprietary high-throughput, digital microscope, and provides "walk-away" automated testing of the HER2 gene to provide an early and accurate indication for gene amplification.

Breast cancer is one of the most common types of cancer in women in the US, and the presence of HER2 gene amplification indicates whether a breast cancer patient is a candidate for Herceptin (trastuzumab) treatment. Increased quantities of HER2 protein can cause rapid tumor growth, resistance to certain types of treatment, decreased disease-free periods and a shorter overall survival, making HER2 breast cancer more aggressive than other types of breast cancer.

"The commercial availability of our oncoFISH her2 breast cancer test is a significant step forward for us," said Dr. Petros Tsipouras, chairman and CEO of Ikonisys. "With this test, laboratories and hospitals will have an economical and accurate method for automating their FISH testing of HER2 breast cancer. This will help them to standardize their diagnostic testing procedures, decrease the wait time for test results and, more importantly, help labs to compensate for the nationwide shortage of lab technicians by enabling them to best maximize their time."

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 enhance their ability to economically deliver accurate, fast and personalized results for early cancer diagnosis and monitoring and genetic disorder screening.

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 reagent kits. 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 more 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.

Ikonisys