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Ikonisys Receives CMS Registration to Establish Clinical Laboratory for Proprietary, Rare-Cell Based Tests
Clinical laboratory also serves as a reference lab for FISH-based non-proprietary testing

New Haven, Conn., March 5, 2008 - Ikonisys, a leading provider of non-invasive, cell-based diagnostic solutions, announced today that it has established a clinical laboratory registered with the Centers for Medicare and Medicaid Services under the CLIA provisions and licensed by the state of Connecticut. The company's clinical laboratory is intended to support proprietary and non-proprietary tests based on fluorescence in situ hybridization (FISH). The clinical laboratory will enable Ikonisys to showcase the breadth and depth of its products including proprietary tests for circulating fetal cells (CFC) and circulating tumor cells (CTC). Most immediately, Ikonisys will initiate clinical trials of its non-invasive oncoFISH® cervical cancer test at the clinical laboratory. Additionally, the clinical laboratory offers FISH-based laboratory testing and services to medical providers that lack the internal resources necessary for this specialized laboratory service. Ikonisys' state-of-the-art facility is designed for rapid turnaround time and accurate, high-quality FISH analysis performed by highly-trained staff with a core competency of FISH testing.

"The launch of the clinical laboratory presents us with a unique opportunity to evaluate several of Ikonisys' new product offerings quickly and effectively," said Bill Nouri, vice president and general manager of clinical laboratories for Ikonisys. "We also look forward to servicing hospitals and medical practices across the country that require non-proprietary FISH testing. With the establishment of this laboratory, we are undoubtedly continuing to demonstrate Ikonisys' commitment to excellence in the rapidly growing area of clinical diagnostics."

Ikonisys' tests are intended for the early diagnosis of genetic disorders and cancer progression, providing medical practitioners and patients with a safe and accurate detection method. Additionally, rare-cell based testing enables physicians a better opportunity to monitor disease progression closely, assess efficacy of treatment and decide upon a personalized treatment plan.

"We are very excited to receive registration for our clinical laboratory and to start operating as a reference laboratory for rare cell detection. With the launch of the clinical laboratory, we can effectively serve as a critical partner and resource to medical institutions that wish to perform proprietary testing of FISH products," said Dr. Petros Tsipouras, chairman and CEO of Ikonisys. "The availability of this laboratory also enables us to start immediate evaluation of our cervical cancer test, which will provide women with fast and accurate test results needed to make better, more informed healthcare decisions."

Ikonisys' proprietary and non-proprietary tests are supported by its CellOptics® platform, a unique integration of intelligent imaging, microscopy, biology and informatics. The company's proprietary technology, the Ikoniscope®, is a robotic, optical microscope that offers labs high operational throughput, remote access and increased accuracy.

About Ikonisys

Ikonisys is changing the practice of diagnostic medicine through its unique CellOptics platform. Through an innovative combination of intelligent imaging, microscopy, biology and informatics, Ikonisys enables physicians and researchers to deliver accurate, fast and personalized results for early cancer diagnosis, genetic disorder screening and fertility testing.

Ikonisys' solutions enable its customers to launch novel, new tests designed to achieve rare cell detection. Ikonisys offers both large and regional reference labs, hospitals, research institutions and practice groups the ability to expand test volume capacity during an industry-wide shortage of trained technical personnel.

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.

Media Contact:
Jackie Hanley
Racepoint Group