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FDA Clears Applied Spectral Imaging (ASI)'s GenASIs Advanced Imaging for UroVysion Analysis


1/30/2012 7:28:46 AM

CARLSBAD, Calif.--(BUSINESS WIRE)--Applied Spectral Imaging (ASI) announced today that ASI’s GenASIs Scan & Analysis, SpotScan used for the detection of chromosomal aberrations in bladder cancer has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.

GenASIs Scan and Analysis, SpotScan is intended for in-vitro diagnostic use as a diagnostic aid for automated and manual classification of bladder cancer cells. Cells of interest are targeted based on color size and their signals pattern assisting in the diagnosis of bladder carcinoma in patients with hematuria. GenASIs Scan & Analysis, SpotScan also assists in the subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

With the introduction of GenASIs 7, ASI has broadened its FDA cleared portfolio and now provides 3 major FDA cleared computerized diagnostic aids for: breast cancer - HER2/neu, CEP XY for counting and classifying fluorescent signals in interphase nuclei and the newly cleared UroVysion test for the detection of cells in urine specimens.

ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable UroVysion test results quickly and cost-effectively.

Dr. Felipe Dominguez MD, President and CEO of Suncoast Pathology Associates said, “Using the GenASIs system from ASI is like having an efficient robotic assistant helping us perform fully automated UroVysion® Bladder Cancer scanning.” Dr. Dominguez further added that “The combined microscope and computer-aided image analysis capabilities of GenASIs help us give faster and more accurate clinical results. GenASIs takes automated UroVysion scanning and analysis to a new level.”

Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received this important FDA clearance. We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost effectively. I am confident that this addition will help further establish ASI as the world leaders in automated and manual FISH imaging and analysis.”

UroVysion is used for the detection of cells in urine specimens, stained with fluorescence in situ hybridization (FISH) using Vysis UroVysion® Bladder Cancer Kit.

About ASI

Applied Spectral Imaging (ASI) makes patient care better through advanced biomedical imaging.

The GenASIs Automated Imaging Platforms for Genetic and Pathology Analysis are the foundation of ASI’s offering. With superior imaging and analysis capabilities, ASI provides state of the art diagnostic aids, offering cytogeneticists and pathologists accurate analysis. GenASIs enables automated tissue analysis for primary diagnostics, with reproducible and reliable results. GenASIs Spectral with HiSKY® adds a new dimension to biomedical image analysis.

GenASIs is FDA cleared for clinical applications such as UroVysion, HER2/neu FISH, CEP XY, Karyotyping and FISH. ASI complies with international quality standards including ISO, CE, CMDCAS and 21CFR part 820.

ASI is the industry's leading microscopy imaging solution provider since 1993 with over 30 registered patents in the US, Europe, Japan and the rest of the world. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.

Contacts

Applied Spectral Imaging

Mr. Dror Armon, Director Sales and Marketing

Phone: +1(800) 611-3466

E-mail: Dror@spectral-imaging.com

www.spectral-imaging.com


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