Illumina, Inc. has announced that it has entered into an agreement with Amgen Inc. to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the US and EU.
Under the terms of the collaboration, premarket approval of the test by the US Food and Drug Administration (FDA) and other regulatory bodies will be sought.
The test will be developed for use with Illumina's MiSeqDx™ instrument, which received premarket clearance from the FDA on November 19, 2013 and was CE-marked for the European Union on July 16, 2013.
The collaboration will seek to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix. Following CE marking and FDA approval, Illumina plans to commercialize the test with a focus on US and EU markets. This collaboration also demonstrates Illumina’s commitment to partnering with therapeutics companies and to bringing its leading NGS technologies into oncology care.
“This collaboration is consistent with our strategy to bring the power of NGS to clinical diagnostics,” said Nick Naclerio, Senior Vice President of Corporate and Venture Development and General Manager of Illumina’s Enterprise Informatics business at Illumina. “With three FDA-cleared NGS products in our portfolio, we intend to complement internal development programs by taking products developed with external partners through the FDA submission process. Amgen is a key partner given their leadership in therapeutic development and strong track record in commercializing novel products.”
Dr. Rick Klausner, Chief Medical Officer and acting General Manager of Illumina’s Oncology business, added, “NGS provides an advantage over traditional technologies that typically detect only one or a few variants. Multigene NGS panels provide a more complete genetic picture of each patient’s tumor, which can better inform critical treatment decisions. We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes.”