Illumina 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 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 19 November 2013 and was CE-marked for the European Union on 16 July 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.
Illumina Oncology business general manager and chief medical officer Dr Rick Klausner noted 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," Dr Klausner added.