Amgen, Illumina deal

Illumina partnered with Amgen to develop and commercialize a companion diagnostic for Amgen's Vectibix panitumumab, a human mAb against epidermal growth factor receptor 1 ( EGFR1; HER1; ErbB1) marketed for metastatic colorectal cancer (mCRC). The partners will seek to validate a multi-gene, next-generation sequencing (NGS)-based test for use with Illumina's MiSeqDx genome sequencing system that can identify Ras mutation status. The companies plan to seek premarket approval from FDA and other regulatory bodies. Illumina plans to commercialize the test, with a focus on U.S. and EU markets.

Amgen markets Vectibix to treat metastatic colorectal cancer (mCRC) in the EU, U.S. and Canada. Vectibix is indicated for wild-type Ras mCRC in the EU and for wild-type K-Ras mCRC in Canada. In the U.S., Vectibix is not indicated in patients with K-Ras (KRAS) mCRC or for whom K-Ras status is unknown. ...