Posted in | Imaging

ASI’s GenASIs Advanced Imaging Receives FDA Clearance

Applied Spectral Imaging (ASI) declared that the United States Food and Drug Administration (FDA) has cleared its GenASIs automated scanning and image analysis system for marketing in the US. This advanced imaging is employed for quantification and detection of HER-2/neu gene and chromosome 17.

The interphase nuclei of human breast cancer tissue specimens are detected and analyzed by using Fluorescence In Situ Hybridization (FISH).

GenASIs Scan and Analysis is capable of functioning as an adjunctive automated enumeration tool to detect amplifications of the HER-2/neu gene in human breast cancer specimens. It enables cytogenetics and pathologist to perform improved in-vitro diagnostics.

GenASIs 7 complements the FDA accredited line of products of ASI. It offers three innovative tools such as the CEP XY that can determine the efficiency of bone marrow transplantation in opposite-sex transplants, HER2/neu FISH which functions as an aiding tool in breast cancer, and the UroVysion for detection of bladder cancer cells in urine specimens. All the test tools have been cleared by FDA.

By integrating ASI’s image analysis systems and manual and automated scanning platform facilitates laboratories to perform the Her2/neu FISH test results more quickly and reliably with reduced cost.

According to ASI’s Chief Executive Officer, Limor Shiposh, the new additional FDA clearance will complement the ASI’s FDA cleared array of tools in the GenASIs platform. With this new achievement, ASI will provide precision clinical results, thereby improving its customer services. Furthermore, ASI anticipates becoming a pioneer in automated and manual FISH imaging and analysis, offering affordable and excellent analysis.



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