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Illumina, Amgen Collaborating on NGS-Based CDx for Colorectal Cancer Drug

NEW YORK (GenomeWeb News) – Illumina and Amgen will collaborate on the development of a next-generation sequencing-based companion diagnostic for the colorectal cancer drug Vectibix (panitumumab), the companies announced yesterday.

Illumina will develop the companion test on its MiSeqDx instrument, which garnered 510(k) clearance from the US Food and Drug Administration in November. The company also registered the platform last year in the European Union with a CE mark.

The label for Vectibix, an EGFR-inhibiting monoclonal antibody marketed by Amgen, restricts the use of the drug for those metastatic colorectal cancer patients who harbor KRAS mutations or whose KRAS status is unknown. The US Food and Drug Administration hasn't yet approved a companion diagnostic that gauges KRAS mutation status specifically in those considering treatment with Vectibix.

However, in 2012, the agency approved Qiagen's Therascreen KRAS RGQ PCR Kit to identify best responders to Erbitux (cetuximab), a drug in the same class as Vectibix. Amgen is also working with Qiagen to advance a PCR-based companion test for Vectibix that detects KRAS mutations.

Illumina is planning to garner regulatory approval in the US and in Europe for an NGS-based companion test that can identify patients' RAS mutation status. KRAS is part of the RAS family of genes. Illumina and Amgen will validate the test platform and Illumina will commercialize the test.

Illumina's MiSeqDx is the first next-generation sequencing platform cleared by the FDA. At the same time, the FDA also greenlighted two cystic fibrosis tests that run on the same instrument.

"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," Nick Naclerio, Illumina's senior VP of corporate and venture development, said in a statement.

Even before garnering regulatory clearance for MiSeqDx, Illumina launched a pharma partnership program under which it offered to work with drug developers to advance companion tests on its NGS platform. Although to date drug developers are largely using NGS in their discovery efforts, they may have more confidence advancing a commercial companion test on such a platform if it has FDA's nod in terms of its analytical validation and design controls.

"Multigene NGS panels provide a more complete genetic picture of each patient's tumor, which can better inform critical treatment decisions," Illumina's chief medical officer Rick Klausner said in a statement. "We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes."

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