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AmoyDx Strikes CDx Development Deal for Merck KGaA Cancer Drug

NEW YORK — Amoy Diagnostics said on Thursday that it has signed an agreement to develop a PCR-based companion diagnostic for Merck KGaA's cancer drug tepotinib (Tepmetko).

Tepotinib is designed to inhibit the oncogenic MET receptor signaling caused by MET gene alterations, including both MET exon 14 (METex14)-skipping alterations and MET amplifications, or MET protein overexpression. The drug was approved by Japanese regulators in March for treating non-small cell lung cancer alongside a companion diagnostic that Darmstadt, Germany-based Merck KGaA developed with ArcherDx. 

Under its deal with Merck KGaA, Xiamen, China-based AmoyDx will develop and seek Japanese approval for its Pan Lung Cancer PCR Panel, which is designed to detect 167 hotspot variants in multiple oncogenes, for use as a METex14-skipping companion diagnostic for tepotinib.

Additional terms were not disclosed.

Earlier this year, the AmoyDx Pan Lung Cancer PCR Panel was selected for first-line screening for patients who potentially benefit from targeted therapy in Japan's Lung Cancer Genomic Screening Project for Individualized Medicine.