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Biocartis, Amgen Sign Development Deal for Idylla CDx Biomarker Tests

NEW YORK (GenomeWeb) – Biocartis announced today that it has signed a companion diagnostic development agreement with Amgen to develop CDx biomarker tests on its Idylla platform for a compound Amgen is developing to treat certain solid tumors.

Financial terms of the agreement were not disclosed.

"Today's announcement is [an] important step in the expansion of our CDx portfolio, which should contribute to short term revenue generation and create a strong pipeline of future Idylla CDx biomarker tests," Ulkrik Cordes, Biocartis' executive vice president of companion diagnostics, said in a statement.

This is Biocartis second recent CDx agreement with Amgen. In December, the companies signed an agreement to seek a premarket approval for Biocartis' Idylla KRAS Mutation Test and Idylla NRAS-BRAF Mutation Test with the US Food and Drug Administration, as companion diagnostic tests for Amgen's Vectibix (panitumumab), a monoclonal anti-epidermal growth factor receptor antibody approved to treat certain metastatic colorectal cancer patients with wild-type RAS. The two Idylla biomarker tests allow for the simultaneous detection of 44 clinically relevant colorectal cancer mutations from formalin-fixed paraffin embedded tumor slices, Biocartis said. Amgen said it would provide financial and operational support to Biocartis for the PMA process.