Amgen and Illumina to develop companion diagnostic for Vectibix

USA-based Illumina (Nasdaq: ILMN) has entered into an agreement with Amgen (Nasdaq: AMGN), the world’s largest independent biotech firm, to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Amgen’s Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer approved in the USA and European Union.

Under the terms of the collaboration, financial terms of which are not disclosed, premarket approval of the test by the US Food and Drug Administration 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 in November 2013, and was CE-marked for the EU in July last year.

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.