ASI receives FDA clearance for GenASIs Scan and Analysis

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."