Illumina, Inc. has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), an anti-EGFR monoclonal antibody for the treatment of metastatic colorectal cancer. The companies will pursue premarket approval of the test from the FDA and other regulatory bodies, and will be developed for use with Illumina's MiSeqDx instrument, which received premarket clearance from the FDA in November, and was CE-marked for the EU in July 2013.
The collaboration will work to validate a test platform that can identify RAS mutation status of patients who would be appropriate to receive Vectibix. Following approval, Illumina plans to commercialize the test in U.S. and EU.
“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, said, “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.”