The GenASIs Scan & Analysis automated microscopy platform from Applied Spectral Imaging (ASI), Carlsbad, Calif, 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), according to the company.
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 United States with more than 1.6 million new cases diagnosed annually.
The platform 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.
It provides quick, repeatable, and documented results and adds the ability to perform walkaway automated genetic tissue scanning for ALK.
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.