Cell SignalingCell Signaling Technology Inc, Danvers, Mass, has received a patent relating to PCR-based methods for the detection of EML4-ALK (anaplastic lymphoma kinase) polynucleotides in patient samples.

The presence of the fusion kinase EML4-ALK has been reported in a subset of patients with breast, colon, and non-small cell lung cancer (NSCLC). Pfizer’s XALKORI® (crizotinib) is approved in the United States for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ALK fusions as detected by an FDA-approved test.

The methods disclosed in the patent, titled “Gene defects and mutant ALK kinase in human solid tumors”, include the amplification of DNA or RNA fusion polynucleotides from patient blood, tissue, or cells and the determination of a therapeutic regimen based on the presence of the fusion in the sample.

Lung cancer is the world’s leading cause of cancer death with more than 1.6 million new cases diagnosed each year, according to the company. About 85% of lung cancer patients are of the non-small cell type and are usually diagnosed with advanced disease with a very low survival rate. Preliminary epidemiology suggests that approximately 3% to 5% of NSCLC patients have tumors positive for the ALK fusion gene.

The company discovered the abnormal gene rearrangement EML4-ALK in NSCLC. The presence of the ALK fusion gene in lung cancer was also reported by a Japanese researcher in 2007. Cell Signaling’s patent portfolio includes other methods of detecting the EML4-ALK fusions, including detection by FISH (fluorescence in situ hybridization) and antibody-based assays for the detection of polypeptides. Cell Signaling and Astellas Pharma Inc have pooled their respective worldwide intellectual property estates relating to the fusion kinase EML4-ALK.

Cell Signaling has also entered into a license agreement with Ventana Medical Systems, Inc, a member of the Roche Group, which, in collaboration with Pfizer Inc, is developing the first fully automated and standardized immunohistochemistry (IHC) companion diagnostic test for ALK gene rearrangements using CST’s D5F3 antibody.

Clinical Lab Products recently spoke with David Hout, PhD, Insight Genetics’ vice president of R&D, on the company’s continuing work on Insight ALK Screen, Insight ALK Resistance, and other biomarker-specific diagnostic tools to advance cancer care. Click here to read.


[Source: Cell Signaling Technology Inc/Photo courtesy of Business Wire]