Danvers, MA – Cell Signaling Technology, Inc. (CST) of Danvers, MA, announced today that it has granted Cepheid, Inc., a worldwide non-exclusive license to CST patent rights relating to the detection of ALK gene rearrangements for the field of PCR (polymerase chain reaction) diagnostic testing. Cepheid will develop a test, which is intended to identify non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) gene rearrangements.

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

CST and one of its partners own dominant rights to the intellectual property directed to the detection of EML4-ALK translocations. The patent rights include method claims that cover IHC (immunohistochemistry), PCR, and gene sequencing platforms as well as patents (US Patent Nos. 8,288,102, and 8,377,642) relating to molecular-based methods for the detection of EML4-ALK. With the recent addition of US patent 8,481,279, which covers methods for inhibiting the progression of lung cancers that express the EML4-ALK fusion gene, CST now has a dominant IP position for EML4-ALK in NSCLC that spans from research through diagnosis and therapy.

“CST is very excited to enter into this agreement with Cepheid for the development of molecular based testing products to add to the diagnostic platform options for EML4-ALK detection,” said Michael J. Comb, Ph.D., CST President and CEO. “We believe it further validates our growing intellectual property portfolio and the research in identifying the expression of EML4-ALK, important to the diagnosis and treatment of cancer patients.”