Illumina, a developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, has entered into an agreement with Amgen 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 U.S. and E.U.
Premarket approval of the test by the 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 Nov. 19 and was CE-marked for the E.U. July 16.
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 U.S. and E.U. markets. This collaboration also demonstrates Illumina’s commitment to partnering with therapeutics companies and to bringing its 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.”
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.”