IVD Companies Collaborate with Pharma on Companion Diagnostics
Dako has signed an agreement with Genentech Inc. to collaborate on the regulatory submissions of Dako’s HercepTest and HER2 FISH pharmDx as companion diagnostics for Herceptin (trastuzumab) in patients with advanced HER2-positive stomach (gastric) cancer. The collaboration involves the use of Dako's extensive experience in developing cancer diagnostic tests to identify cancer patients who may receive greater benefits from a certain therapy. Under the terms of the agreement, Dako and Genentech will collaborate on regulatory submissions for HercepTest and HER2 FISH pharmDx in the U.S. market to identify patients with stomach cancer who may be eligible for treatment with Herceptin if Herceptin is approved for use against that disease. The collaboration is in line with Dako’s ongoing strategy to combine its strengths with biotechnology and pharmaceutical companies to develop the offering of Dako’s companion diagnostic assays. Also, Nanosphere Inc. announced that it has entered into an agreement with Eli Lilly and Co. to collaborate in connection with employing pharmacogenetic assays in drug development initiatives. The two companies have signed the agreement and the financial terms were not disclosed. Nanosphere is developing the pharmacogenetic assays for use with its new Verigene SP(r) system, a sample-to-result, benchtop molecular diagnostics instrument. The turnkey and random access system uses whole blood and requires no PCR. It allows for broad dissemination to recruitment sites which have no molecular laboratories, or to facilities already performing genetic testing.