FDA approves ALK gene diagnostic for lung cancer

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.