Amoy Diagnostics Co. Ltd.

Company Overview

Amoy Diagnostics Co. Ltd. (AmoyDx) is developing and marketing liquid biopsy assays for cancer as well as DNA extraction kits for isolation and purification of DNA from serum or plasma.

In January 2018, the China FDA approved Amoy Diagnostics’ SuperArms EGFR mutation analysis liquid biopsy test as a companion diagnostic for EGFR TKI-based NSCLC drugs. This test uses RT-PCR and can identify EGFR mutations in ctDNA from patients with advanced or metastatic NSCLC. In April 2018, this test received the CE-IVD marking.

During the past several years, Amoy has formed partnerships with several pharmaceutical companies; these partnerships are important for validating and expanding the use of Amoy’s companion diagnostics PCR- and NGS-based tests.

In November 2019, Amoy Diagnostics partnered with Eisai Co. Ltd. covering the development and registration of companion diagnostic tests. The companies will work on tests for emerging valuable targets in the oncology space.

In March 2020, Amoy Diagnostics formed a partnership with Johnson & Johnson Investment Ltd. to develop an oncology companion diagnostic test based on AmoyDx’s NGS technology. The agreement covered AmoyDx’s LC10-Essential NGS Panel, for which Amoy agreed to pursue National Medical Products Administration (NMPA) approval for use as a companion diagnostic for an oncology therapy.

In May 2020, AmoyDx began a collaboration with Amgen to develop companion diagnostics supporting an investigational molecule within Amgen’s oncology portfolio for the Chinese market. The partners agreed to develop and register AmoyDx Lung Cancer PCR Panel in China, to get NMPA approval for an intended use as a companion diagnostic for AMG 510, an investigational small molecule designed to specifically and irreversibly inhibit KRASG12C in people with NSCLC.

In August 2020, Amoy formed a strategic alliance with Haihe Pharmaceutical to develop its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a companion diagnostic test for the Japanese market. The companies agreed to developed a CDx based on AmoyDx’s PCR platform 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.

In December 2020, AmoyDx formed a partnership with Merck KGaA to develop a PCR-based companion diagnostic for Merck KGaA’s cancer drug MET inhibitor, Tepmetko (tepotinib). Tepotinib is a selective small molecule drug designed to inhibit MET in patients with NSCLC and MET alterations.

In February 2021, AmoyDx partnered with AstraZeneca to develop a companion diagnostic for use in treating ovarian cancer patients with homologous recombination deficiency (HRD).

Company's Business Segments

• Oncology Products : The company generates revenue through various oncology products such as HRD Focus Panel, HRD Complete Panel​, Master Panel, BRCA Pro Panel, and many others.
• Pharma Service : Services regarding drug development, including Drug-related Biomarker Discovery, Bespoke Assay Development, Global Assay Transfer, CTA service, Companion Diagnostics Kits Development, and Post-Marketing Investigational Studies.