FDA Clears ASIs Advanced FISH Imaging System for Breast Cancer Diagnostics

Applied Spectral Imaging (ASI) announced yesterday that its GenASIs automated scanning and image analysis system has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US. The Gen ASIs Scan and Analysis is intended to assist cytogeneticists and pathologists in breast cancer diagnostics.

GenASIs detects and quantifies amplifications of the HER-2/neu gene, in breast cancer specimens. The analysis is provided using highly reliable Fluorescence In Situ Hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.

FDA clearance of the GenASIs 7 broadens ASI’s FDA cleared portfolio to 3 major tests. Also included is CEP XY for assessing effectiveness of bone marrow transplantation in opposite sex transplants; and UroVysion for detection of bladder cancer cells in urine specimens.

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.”

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.