Amoy Diagnostics

What Amoy Diagnostics does

Amoy Diagnostics (Xiamen Amoy Diagnostics Co., Ltd. / 厦门艾德生物医药科技股份有限公司) is a publicly listed Chinese molecular diagnostics company founded in 2008 by Professor Zheng Limou and headquartered in Xiamen, Fujian. The company specializes in tumor precision medicine companion diagnostics (CDx), operating across four technology platforms — PCR (ADx-ARMS®, Super-ARMS®), NGS (ddCapture®, ADx-HANDLE®), FISH, and IHC — and holding 30+ NMPA Class III product approvals covering lung, colorectal, breast, gastric, ovarian, prostate, biliary and thyroid cancers. Its products serve two principal customer sets: 500+ tier-3 hospital pathology/molecular laboratories in China (representing ~60% institutional CDx market share) and 20+ global pharmaceutical companies that co-develop CDx reagents alongside their targeted and immunotherapies.

The business model combines one-time kit/reagent sales to hospitals with professional services revenue tied to pharma partnership programs (CDx co-development, clinical trial support, regulatory filing services). Pricing is set via institutional procurement and government insurance reimbursement rather than list pricing. Internationally, products are sold through distributor networks across 70+ countries, with direct regulatory registration and reimbursement inclusion in Japan (NHI), South Korea, Taiwan, and CE-marked products in the EU. The in-house Xiamen AmoyDx Medical Laboratory (CAP, ISO15189 accredited) provides third-party molecular testing services and feeds clinical validation data back into the product pipeline.

FY2025 reported revenue of 1,198 million RMB (~$166M) and net profit of 361 million RMB (+41.74% YoY) underscore a profitable, growing business model. Manufacturing runs at a daily capacity of 100,000+ tests from a GMP-certified facility, with 15-20% of revenue reinvested into R&D. Revenue is increasingly diversified through multi-year CDx reagent annuities tied to partner drug launches (AstraZeneca, Pfizer, Janssen, Amgen, Eli Lilly, Merck, Roche, Eisai, BeiGene, Hutchmed, Hengrui, Haihe, Takeda, Boehringer Ingelheim, Servier), supplementing domestic hospital reagent sales.

Name

Amoy Diagnostics

Legal name

厦门艾德生物医药科技股份有限公司

Website

https://amoydx.com

Company type

Public

Founded year

2008

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Amoy Diagnostics is a publicly listed Chinese molecular diagnostics company that develops and commercializes companion diagnostic kits for oncology precision medicine, serving 500+ Chinese hospitals and co-developing CDx products with 20+ global pharmaceutical companies.

Ownership category

akta.pro rank

Product category

Oncology Companion Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Immuno-Oncology & Immune Monitoring Biomarkers (TMB, MSI, MRD, immune profiling) (HLAAAMAK), Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Molecular diagnostics kits
• Oncology companion diagnostics
• Precision medicine testing
• Cancer genetic testing
• Tumor mutation detection

Headquarters

HQ city

Xiamen

HQ country

China

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Companion Diagnostic Kits and Reagents Sales: Sale of III-class medical device diagnostic reagents and kits to hospitals and laboratories. Products include PCR, NGS, FISH, IHC panels covering major cancer types. Primary revenue driver through direct hospital sales (500+ hospitals) and international distribution.
2. Pharmaceutical Partnership - CDx Co-development: Strategic companion diagnostic development partnerships with global pharma companies (AstraZeneca, Pfizer, Janssen, Amgen, Eli Lilly, Merck, Roche, etc.). Revenue derived from CDx development services, regulatory filing support, and companion diagnostic product supply for clinical trials and post-approval commercialization.
3. Medical Laboratory Testing Services: Xiamen AmoyDx Medical Laboratory provides third-party molecular testing services to hospitals, pharmaceutical companies, and patients. Holds medical institution practice license, CAP and ISO15189 certifications.
4. International Distribution: Products sold through international distributor networks to 70+ countries. Products approved and reimbursed in Japan, South Korea, Taiwan, with direct registration and commercialization in Japan through local partners.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Amoy Diagnostics develops, manufactures, and commercializes Class III molecular diagnostic kits and reagents for oncology precision medicine, covering PCR, NGS, FISH, and IHC technology platforms. Its products detect tumor-driving gene mutations (EGFR, ALK, ROS1, KRAS, BRAF, HER2, BRCA1/2, MSI, PD-L1, etc.) used as companion diagnostics to guide targeted therapy and immunotherapy selection for cancer patients. The company also operates a third-party medical testing laboratory (CAP/ISO15189 accredited) and co-develops companion diagnostics with 20+ global pharmaceutical companies.

Product overview

艾德生物是专注于肿瘤精准医疗分子诊断的领先企业，构建了PCR、NGS、FISH、IHC四大技术平台的完整产品线。主要产品包括：艾惠捷®（PCR-11基因）作为首个中日欧三地获批的肿瘤多基因联检PCR产品；维惠健™（NGS 10基因）作为跨癌种伴随诊断NGS产品；维汝健™（BRCA1/2 NGS）开创国内BRCA基因NGS检测获批先例；Super-ARMS® EGFR系列作为首个以伴随诊断标准获批的液体活检ctDNA产品；PD-L1抗体试剂作为首个国产免疫治疗伴随诊断；MSI检测试剂盒作为首个泛癌种免疫治疗伴随诊断。此外还有HER2、FISH、FGFR2、Met等多种基因检测产品，以及独立运营的艾德医学检验所提供的检测服务。公司已获批30余种肿瘤诊断产品，覆盖各大癌种，在日本、韩国、欧盟等多个国家和地区获批上市并进入当地医保。

Differentiator

Problem solved

Functional benefit

Brands

• 艾惠健 (Aihuaijian): Multi-gene PCR detection product for NSCLC covering 11 driver genes including EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1/2/3. Approved in China, Japan and EU.
• 维惠健 (Weihuijian)
• 维汝健 (Weirujian)
• Super-ARMS
• ADx-ARMS
• ddCapture

Products and services

• 艾惠捷 (PCR-11 Gene Panel / Multi-gene Joint Detection Kit) PCR-based multi-gene joint detection kit for NSCLC driver gene mutations and fusions using DNA and RNA co-detection. Approved in China, Japan and EU. Adopted by Japan's LC-SCRUM Asia network across 200+ hospitals.
• 维惠健 (WeiHuiJian / 10-Gene NGS Panel Joint Detection Kit) NGS-based joint detection kit covering 10 genes for NSCLC and colorectal cancer, including 5 companion diagnostics. Covers all targeted therapy biomarkers for lung and colorectal cancer for the next 3-5 years.
• 维汝健 (WeiRuJian / BRCA1/2 Gene Mutation Detection Kit) NGS-based BRCA1/2 mutation detection kit covering all coding regions, exon-intron boundaries, UTR and promoter regions. Used as companion diagnostic for PARP inhibitors in ovarian, breast and prostate cancer.
• Super-ARMS® EGFR Mutation Detection Kit Liquid biopsy EGFR mutation detection kit based on proprietary Super-ARMS® technology with 0.2% sensitivity for blood ctDNA. Detects 42 mutation types with pre-packaged reagents. First ctDNA companion diagnostic approved in China.
• KRAS/NRAS/PIK3CA/BRAF Gene Mutation Joint Detection Kit Fluorescence PCR-based kit for simultaneous detection of KRAS, NRAS, PIK3CA, and BRAF mutations in colorectal cancer FFPE samples, supporting targeted therapy decisions.
• PD-L1 Antibody Reagent (IHC, Clone E1L3N) IHC-based PD-L1 detection reagent (clone E1L3N) for guiding pembrolizumab first-line treatment in NSCLC. China's first domestic PD-L1 companion diagnostic for immunotherapy.
• MSI Detection Kit (Microsatellite Instability) China's first approved pan-cancer immunotherapy companion diagnostic for microsatellite instability (MSI) testing to guide immunotherapy treatment decisions.
• c-Met Gene Amplification Detection Kit (FISH) FISH-based companion diagnostic for MET gene amplification detection in NSCLC, used with savolitinib from Hutchmed. World's first approved MET FISH CDx.
• FGFR2 Gene Break-apart Detection Kit (FISH) FISH-based detection kit for FGFR2 gene fusions, approved in Japan as CDx for Eisai's Tasurgratinib in cholangiocarcinoma (biliary tract cancer).
• PIK3CA Mutation Detection Kit (Japan) PIK3CA mutation detection kit approved in Japan as companion diagnostic for risovalisib (Haihe Biopharma/Taiho) in PIK3CA-mutant ovarian clear cell carcinoma.
• AmoyDx HRD Complete Panel HRD (Homologous Recombination Deficiency) detection panel based on proprietary ADx-GSS algorithm for PARP inhibitor patient selection in ovarian cancer, co-developed with AstraZeneca.
• HER2 Antibody Reagent (Biliary Tract Cancer CDx) HER2 antibody reagent approved as companion diagnostic for biliary tract cancer, expanding the IHC product portfolio.
• Thyroid Cancer Auxiliary Diagnostic Products

Quantifiable outcome

• PCR-11 gene panel achieved 98.5% detection success rate vs 87.8% for leading NGS panels in LC-SCRUM Japan study (n=406 samples), enabling 10 additional patients to access targeted therapy who would have failed NGS testing
• +4 more outcomes

Named customers12 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature10 records

Partnerships

22 partnerships are on record, tiered core, major and minor.

• Riken Genesis + Precision Medicine Asia (PREMIA)coreChannel Partner/ Reseller/ Distributor · 28 April 2026Japan market partners for PCR-11 gene CDx registration and commercialization. Riken Genesis (founded 2007, CLIA certified) provides laboratory testing and gene testing products. PREMIA manages Asia's largest clinical genomic lung cancer registry (20,000+ patients) across 200+ hospitals in Japan, Taiwan, Malaysia, Thailand.
• Haihe Biopharma + Taiho (海和药物 + 大鵬薬品)coreStrategic or Co-development Partner · 30 March 2026PIK3CA Mutation Detection Kit CDx for risovalisib (瑞索利塞片, 海泽欣®) approved in Japan (March 23, 2026). Risovalisib licensed to Taiho for Japan development, manufacturing, and commercialization. Medical Biology Laboratory (Tokuyama Group) obtained manufacturing/marketing approval as CDx.
• Servier (施维雅)majorStrategic or Co-development Partner · 26 June 2024IDH1/2 NGS CDx development for vorasidenib in China. Vorasidenib is a dual IDH1/2 inhibitor for IDH-mutant diffuse glioma (LGG). AmoyDx to use proprietary NGS panel for CDx development and China registration.
• Pfizer (辉瑞) - OASIS EcosystemmajorGTM or Marketing Partner · 9 November 2023OASIS肺癌创新生态圈 (OASIS Lung Cancer Innovation Ecosystem) partnership at CIIE 2023. Collaboration with Pfizer on肺癌 precision diagnosis market expansion, bringing合规 (compliant) innovative products to broader markets.
• Hengrui Medicine (恒瑞医药)majorStrategic or Co-development Partner · 2 November 2023PD-L1 CDx (E1L3N clone) for camrelizumab (卡瑞利珠单抗). AmoyDx PD-L1 IHC CDx was China's first domestically-developed PD-L1 CDx, included in NCCN/Chinese expert consensus.
• AstraZeneca + Merck MSD (阿斯利康+默沙东)coreStrategic or Co-development Partner · 24 July 2023HRD CDx for Lynparza (olaparib, 奥拉帕利) in China. AmoyDx's proprietary ADx-GSS HRD scoring algorithm to support HRD-positive advanced epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer patients for olaparib first-line maintenance treatment.
• Haihe Biopharma (海和药物)coreStrategic or Co-development Partner · 9 March 2023MET inhibitor glumetinib (谷美替尼, 海益坦®) CDx in China and Japan. PCR-11 gene as glumetinib CDx approved in China (March 2023) and Japan (July 2024). Also FDA IND support for US market. Multiple CDx collaborations ongoing.
• Hutchmed (和黄医药)coreStrategic or Co-development Partner · 20 December 2022MET FISH CDx for savolitinib (赛沃替尼) approved in China (March 2026). World's first approved MET FISH CDx. Also collaborated on CRC precision medicine with Merck KGaA.
• BeiGene (百济神州)coreStrategic or Co-development Partner · 11 October 2022HER2 IHC and FISH CDx strategic partnership for BeiGene's HER2-targeted oncology pipeline in China. Also BRCA1/2 CDx for pamiparib (帕米帕利, 百汇泽®) approved in China (May 2021).
• Roche (罗氏制药)majorGTM or Marketing Partner · 12 August 2022Pan-tumor precision diagnosis ecosystem strategic partnership announced at Roche China Innovation Ecosystem Forum. Collaboration on泛肿瘤 patient diagnosis pathway and individualized precision treatment. Entrectinib NTRK CDx support in China.
• AstraZeneca (阿斯利康)coreStrategic or Co-development Partner · 6 November 2020Long-term strategic partner since 2012. Multiple collaborations: global companion diagnostic partnership (expanding from China to Japan, EU, and international markets), ovarian cancer HRD CDx development, lung cancer HER2 CDx development, county-level precision diagnosis market partnership (县域市场), and broader oncology ecosystem collaboration. Products include ROS1, HRD, HER2, and multiple PCR-11 gene CDx. First CDx partnership with international pharma in 2012.
• Takeda (武田制药)coreStrategic or Co-development Partner · 26 August 2020EGFR exon 20 inhibitor mobocertinib (莫博赛替尼) CDx in China. PCR-11 gene and NGS 10-gene panels used as mobocertinib CDx, approved in China (March 2023).
• Merck KGaA Germany (德国默克)coreStrategic or Co-development Partner · 10 August 2020MET inhibitor Tepotinib CDx partnership for Japan market. PCR-11 gene (艾惠健® upgrade version) to be registered as Tepotinib CDx in Japan. Tepotinib approved in Japan March 2020. Also collaborated on colorectal cancer KRAS/NRAS/BRAF blood vs tissue study.
• Amgen (安进)coreStrategic or Co-development Partner · 22 May 2020KRAS G12C CDx for Lumakras (sotorasib, AMG510) in China and Japan. PCR-11 gene product approved in Japan as sotorasib CDx (November 2022). Partnership announced in 2020 supporting sotorasib China/Japan clinical development and registration.
• Janssen (Johnson & Johnson, 强生)coreStrategic or Co-development Partner · 24 March 2020Strategic CDx partnership for J&J tumor product line. AmoyDx NGS 10-gene panel (维惠健®) to support J&J oncology pipeline CDx registration expansion. EGFR exon 20 amivantamab (锐珂®) CDx approved in China (April 2025). BRCA1/2 as Zelbonki® (尼拉帕利阿比特龙片) CDx approved (December 2025).
• Eisai (卫材)coreStrategic or Co-development Partner · 22 November 2019Global diagnostic collaboration for Eisai's novel oncology targets. FGFR2 gene break-apart FISH CDx for Tasurgratinib approved in Japan (September 2024) for biliary tract cancer. First FISH CDx developed with Eisai for FGFR2 fusion cholangiocarcinoma.
• National Cancer Center Japan / LC-SCRUM Asia (日本国家癌症中心)coreStrategic or Co-development Partner · 27 September 2019LC-SCRUM Asia program collaboration since 2019. PCR-11 gene (艾惠健®海外版) adopted for NSCLC patient screening in LC-SCRUM Asia (200+ hospitals across Japan, Taiwan, Korea, Singapore). Japan's National Cancer Center validated PCR-11 gene outperforming leading international NGS products. Product validated with 97.4% overall concordance (OPA: 96.3%, NPA: 98.9%).
• Eli Lilly / LOXO Oncology (礼来制药)coreStrategic or Co-development Partner · 23 June 2019RET inhibitor selpercatinib (loxo-292) CDx partnership for Asia clinical trials. PCR-11 gene and NGS 10-gene panels used as CDx for LOXO-292 Asia clinical studies in China, Japan, and Taiwan. Product approved in Japan as selpercatinib CDx (March 2023).
• Sanomics (善觅有限公司)minorChannel Partner/ Reseller/ Distributor · 28 January 2019Multi-gene testing service partnership for Hong Kong and Macau lung cancer patients. Based on AmoyDx's 艾惠健® product, Sanomics launched 'Oncosnap Nonet™' service for 9 core gene testing. Co-founded by Prof. Tony Mok (莫树锦).
• IlluminacoreTechnology or Integration · 20 November 2018Strategic partnership for NGS product development. AmoyDx's first NGS product (维惠健®, 10-gene panel) developed through this partnership using Illumina's sequencing platform. Product received NMPA approval through innovative medical device review pathway (November 2018).
• Boehringer Ingelheim (勃林格殷格翰)majorStrategic or Co-development Partner · 10 January 2017Lung cancer EGFR mutation blood detection project for China market. Super-ARMS® EGFR blood test to enable 一管血 (single blood tube) EGFR testing. Afatinib (阿法替尼) CDx support. Partnership on EGFR blood testing standardization in Chinese hospitals.
• Pfizer (辉瑞)coreStrategic or Co-development Partner · 1 January 2012ROS1 CDx for crizotinib (Xalkori) in Asia-Pacific clinical trials (OO-1201). AmoyDx ROS1 product was first Chinese CDx product approved in Japan (2017) and South Korea (2018) as crizotinib companion diagnostic and included in Japan National Health Insurance.

Scale indicators10 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Burning Rock Biotech: China-based oncology NGS company that develops companion diagnostics for solid tumors, directly competing with AmoyDx for pharma CDx partnerships and Chinese hospital NGS accounts.
• Geneseeq Technology (Nanjing Geneseeq): Chinese oncology NGS/CDx company offering similar multi-gene panels for NSCLC and other solid tumors, competing head-to-head for pharma CDx deals and hospital accounts in China.
• Berry Genomics: Chinese genomics and molecular diagnostics company with NIPT heritage that has expanded into oncology NGS and rare disease testing, overlapping with AmoyDx in molecular IVD.
• Guardant Health: US-based liquid biopsy leader whose Guardant360 CDx is approved alongside multiple targeted therapies — directly overlaps with AmoyDx's Super-ARMS EGFR liquid biopsy franchise and pharma CDx pipeline.
• Myriad Genetics: US-based molecular diagnostics company whose BRCA/HRD franchise was the historical monopoly that AmoyDx's ADx-GSS algorithm disrupted; overlaps directly in PARP-inhibitor CDx.

Broad incumbents

• BGI Genomics: China's largest genomics company with broad sequencing services, IVD kits, and oncology testing — overlaps with AmoyDx in molecular diagnostics but operates at vastly greater scale across many segments.
• Foundation Medicine (Roche): Global leader in tissue and liquid biopsy comprehensive genomic profiling; competes with AmoyDx for global pharma CDx contracts and is a benchmark for NGS-based CDx validation.
• NeoGenomics: US oncology-focused clinical lab and IVD company offering solid tumor profiling, FISH, IHC, and NGS services — competes with AmoyDx's NGS and FISH product lines for global hospital contracts.

Regional players

• DaAn Gene (Sun Yat-sen University DaAn Gene): Major Chinese IVD and molecular diagnostics manufacturer with broad infectious disease and oncology test menus — competes with AmoyDx in domestic hospital reagent sales and COVID-era PCR platform expansion.

Emerging players

• Caris Life Sciences: US-based molecular profiling company combining tissue WES/WTS with AI-driven CDx development; emerging competitor in pan-cancer profiling and pharma CDx services where AmoyDx also operates.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/AmoyDx
• Facebookfacebook.com/amoydx
• LinkedInlinkedin.com/company/amoy-diagnostics

Compliance13 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries2 records

Funding overview

Funding rounds2 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Amoy Diagnostics