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Amoy Diagnostics, Haihe Pharmaceutical Ink Agreement to Codevelop CDx for Lung Cancer Treatment

NEW YORK ─ Amoy Diagnostics of Xiamen, China, said on Thursday that it has inked an agreement with Shanghai-based Haihe Pharmaceutical to codevelop a companion diagnostic test for the Japanese market.

The CDx, based on AmoyDx's PCR platform, is being developed for use with Haihe's MET kinase inhibitor Glumetinib (SCC244), which targets c-MET exon14 skipping alterations in patients with non-small cell lung cancer.

Under the terms of the agreement, the companion diagnostic test developer will seek Pharmaceutical Medical Devices Agency (PMDA) approval in Japan for use of its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a c-MET exon14 skipping CDx for Glumetinib (SCC244).

Additional terms were not disclosed.

"AmoyDx has a strong pipeline of diagnostic products for precision medicines, as well as successful CDx development experience in Japan," 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."

The company recently inked an agreement to develop a PCR-based companion diagnostic for Merck KGaA's cancer drug Tepmetko (tepotinib).