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FDA Clears ASI Gene Scanner as PGx Tool for NSCLC

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Applied Spectral Imaging's GenASIs Scan & Analysis automated gene scanner as an aid in ALK gene analysis for lung cancer therapy selection, ASI said this week.

The GenASIs Scan & Analysis, a microscopy platform, is used for the genetic analysis of tissue samples stained with the Abbott Vysis ALK Break Apart FISH Probe test for identifying ALK gene rearrangement. The kit identifies ALK-positive non-small cell lung cancer patients who may be suitable for Pfizer's Xalkori (crizotinib).

FDA approved Abbott's kit and Xalkori in August 2011 for NSCLC.

According to Carlsbad, Calif.-based ASI, "Automated genetic analysis with GenASIs Scan & Analysis ensures quick, repeatable, and documented results proving unparalleled clinical accuracy and time savings."

In a statement ASI CEO Limor Shiposh said, "ALK is an important addition to our suite of FDA-cleared computerized clinical diagnostic aids. 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."

The Scan

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