FDA Clears ASI’s GenASIs Advanced Imaging for HER-2/neu Analysis
Targeting the Right Treatment for the Right Patient in Breast Cancer Diagnostics
Carlsbad, Calif., February 20, 2012 – – Applied Spectral Imaging (ASI) announces that ASI’s GenASIs automated scanning and image analysis system for detection and quantifying chromosome 17 and the HER-2/neu gene has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US.
Detection and analysis is concluded via Fluorescence In Situ Hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.
GenASIs Scan and Analysis is intended for in-vitro diagnostic use as an adjunctive automated enumeration tool to assist the cytogenetics and pathologist to detect amplifications of the HER-2/neu gene in human breast cancer specimens.
With the introduction of GenASIs 7, ASI has broadened its FDA cleared portfolio and now provides 3 major FDA cleared tests: an aiding tool in breast cancer – HER2/neu FISH, CEP XY used to assess effectiveness of bone marrow transplantation in opposite-sex transplants and UroVysion for detection of cells in urine specimens from persons suspected of having bladder cancer.
ASI’s manual and automated scanning platform and image analysis systems enable laboratories to provide highly reliable Her2/neu FISH test results quickly and cost-effectively.
Limor Shiposh, ASI’s Chief Executive Officer said, “We are pleased to have received an additional and 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.”
The GenASIs Automated Imaging Platforms for Genetic and Pathological 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 Hyperspectral with HiSKY® Probes adds a new dimension to biomedical image analysis.
GenASIs is FDA cleared for FISH clinical applications such as UroVysion, HER2/neu, CEP XY and Karyotyping. ASI complies with major regulatory requirements and international quality standards.
ASI is the industry’s leading microscopy imaging solution provider since 1993, with over 30 registered patents in the US, Europe and Japan and over 2,500 systems deployed worldwide. With worldwide offices in the US, Europe and Asia, ASI has built a global network of over 50 distributors.
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