World's First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available from ASI

Applied Spectral Imaging (ASI) announced today that its GenASIs Scan & Analysis automated microscopy platform has received FDA clearance as an aid in ALK gene analysis for lung cancer therapy selection. The introduction of automation in ALK therapy selection represents a new era in personalized medicine for patients with NSCLC (Non-Small-Cell-Lung-Cancer).

About 85% of lung cancer patients have NSCLC and are commonly diagnosed at an advanced disease stage with very low survival rate. Lung cancer is the leading cause of cancer related death in the US with over 1.6 million new cases diagnosed annually.

GenASIs Scan & Analysis offers clinicians a way to automatically perform genetic analysis on tissue samples, stained with the Abbott ALK™ probe kit, and identify the ALK gene rearrangement.

Automated genetic analysis with GenASIs Scan & Analysis ensures quick, repeatable and documented results proving unparalleled clinical accuracy and time savings. GenASIs further adds the ability to perform “walk away” automated genetic tissue scanning for ALK using an 81 slide continues scanning robot.

The Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer’s approved NSCLC therapy, XALKORI® (crizotinib), an oral first-in-class ALK inhibitor. The Vysis test uses in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome. The diagnostic test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from XALKORI® (crizotinib) therapy.

“We are proud to be the first to offer an automated platform to aid in ALK therapy selection for Non-Small-Cell Lung Cancer patients. This significant achievement further affirms ASI’s commitment to offer new and innovative tools to make personalized medicine using companion diagnostics more available and more effective.” said Limor Shiposh, ASI’s Chief Executive Officer.

Limor further added, “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. I am confident that this addition will help further establish ASI as the world leader in automated and manual FISH imaging and analysis.”