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Amoy Diagnostics, Merck KGaA Partner for Lung Cancer Companion Diagnostic Development in China

NEW YORK – Amoy Diagnostics announced Wednesday that it has signed an agreement with Merck KGaA to develop a companion diagnostic test in China to support Merck KGaA's novel MET inhibitor tepotinib (Tepmetko).

Tepotinib is a selective small molecule drug designed to inhibit MET in subjects with non-small cell lung cancer and MET alterations. 

Under the agreement, Xiamen-based AmoyDx will develop and register a lung cancer PCR panel called the AmoyDx Lung Cancer PCR Panel (11-in-1 Panel) with the aim of obtaining regulatory approval for intended use as a MET exon14 skipping companion diagnostic for tepotinib.

"AmoyDx has a strong pipeline of diagnostic products for precision medicines, as well as successful CDx development experience in China," Li-Mou Zheng, the firm's founder and CEO, said in a statement. "Exploiting our test to help guide treatment decisions will address a high unmet medical need from patients," Zheng added.

Earlier this year AmoyDx partnered with Merck KGgA to develop and seek approval in Japan 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.

AmoyDx has also recently partnered with Haihe Pharmaceutical, Janssen Research and Development, and Eisai, to develop companion diagnostic tests.