MEDx

What MEDx does

MEDx Translational Medicine Co., Ltd, founded in 2013 in Suzhou, China (spun out from QIAGEN's translational medicine research center), is a privately held companion diagnostics (CDx) and translational medicine company serving global pharmaceutical and biotechnology sponsors and oncology healthcare providers. The company operates integrated technology platforms spanning genomics (NovaSeq 6000, HiSeq XTen, NextSeq 500 sequencers), proteomics, cytomics, pathology (IHC, mIHC, FISH, ISH, RNAscope, digital pathology), and bioinformatics with AI-assisted interpretation software, supported by an automatic digital PCR system. Its commercial portfolio includes 20+ NMPA-approved IVD/CDx products, 8 CE-certified products, 150+ validated biomarker assays, and 40+ CDx pipelines, alongside a comprehensive NGS panel catalog spanning pan-solid tumor, hematologic malignancy, HRD, MRD, and TMB applications. MEDx generates revenue through three streams: professional pharma services and CDMO work for drug clinical trials (biomarker discovery, validation, PK/PD/ADA bioanalysis), one-time IVD/CDx product sales (IHC, PCR, and NGS assays), and central laboratory clinical testing services. The company engages global pharma through direct B2B sales, has executed 650+ international projects across 10+ countries including the US, Australia, and Singapore, and maintains 250 active clinical trial engagements. Strategic partnerships with Illumina (sequencing platforms), Abcam (antibody supply), and Junshi Biosciences (co-development) anchor its platform, with NMPA, FDA, and CE regulatory capabilities plus CAP, ISO 13485, CNAS/ISO 17025, GMP, and GSP quality certifications supporting multi-jurisdiction commercialization.

Name

MEDx

Legal name

MEDx Translational Medicine Co., Ltd

Website

https://medxtmc.net

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

11–50 employees

Short description

MEDx is a Suzhou-based companion diagnostics company spun out from QIAGEN in 2013, offering integrated translational medicine platforms spanning genomics, proteomics, pathology, and bioinformatics to global pharmaceutical sponsors, with 20+ NMPA-approved products and 250 active clinical trial engagements.

Ownership category

akta.pro rank

Product category

Companion Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (62151)

SIC

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

akta.pro primary industry

Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC)

akta.pro secondary industries

Companion Diagnostics (CDx) Development & Trial Testing Support (HLAGAEAJ), Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB), Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF)

Keywords

• Companion diagnostics
• Precision medicine
• Translational medicine
• Biomarker testing
• Molecular diagnostics

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharma Services and CDMO: Comprehensive translational medicine services including biomarker discovery, validation, PK/PD/ADA bioanalysis for drug clinical trials, supporting pharmaceutical companies throughout drug development lifecycle
2. IVD/CDx Product Sales: Sale of registered IVD and companion diagnostics products including IHC, PCR, and NGS-based assays for solid tumors and blood cancers
3. Clinical Testing Services: Central laboratory testing services for clinical trials and patient diagnostics including pan-solid tumor tests, hematologic malignancy tests, and infectious disease testing

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

MEDx develops and commercializes companion diagnostic (CDx) products and provides integrated translational medicine services for pharmaceutical companies. Its product portfolio spans IHC, PCR, and NGS-based assays for solid and blood tumors, while its service offerings cover biomarker discovery, clinical trial central laboratory support, PK/PD/ADA bioanalysis, and end-to-end IVD/CDx R&D and commercialization for precision oncology.

Product overview

MEDx Translational Medicine Co., Ltd offers a comprehensive portfolio of companion diagnostic products and translational medicine services. The product portfolio spans three technology platforms: IHC-Based Assays (including PD-L1 E1L3N, Claudin 18.2, MMR Panel, c-MET IHC), PCR-Based Assays (including MSI Dx, c-MET Exon 14 Skipping, MET Amplification, HER2 Amplification, AR-V7, JAK2-V617F), and NGS-Based Assays (including MiniCDx 95-gene, HEMECDx 505-gene, HemeMRD, Med1CDx 601-gene, OncoCDx 191-gene, HRDetectCDx, panFGFx custom panels). The company provides integrated translational science, clinical trials, and CDx development services to pharmaceutical companies for drug development and precision medicine.

Differentiator

Problem solved

Functional benefit

Products and services

• PD-L1 (E1L3N) Antibody Kit (IHC) Immunohistochemistry-based companion diagnostic assay for detecting PD-L1 protein expression in tumor tissues to guide immune checkpoint inhibitor therapy (e.g., nivolumab) for pharmaceutical sponsors and oncology clinicians.
• Claudin 18.2 IHC Kit IHC assay for detecting Claudin 18.2 protein in FFPE tissue sections to identify patients who may benefit from Claudin 18.2 targeted therapy in gastric and pancreatic cancers; for pharmaceutical CDx programs and oncology clinicians.
• MMR IHC Panel Immunohistochemistry panel detecting MLH1, MSH2, MSH6, and PMS2 proteins to identify mismatch repair deficiency (dMMR) for Lynch syndrome screening and immunotherapy guidance.
• c-MET IHC Kit IHC assay for detecting c-MET protein overexpression in pan-solid tumors, primarily lung cancer, to guide MET-targeted therapy selection.
• Microsatellite Instability (MSI) Dx Analysis Test PCR-based assay detecting nine mononucleotide repeat sites to determine MSI status for colorectal cancer diagnosis and immunotherapy guidance.
• c-MET Exon 14 Skipping RT-qPCR Test RT-qPCR assay for qualitative detection of c-MET exon 14 skipping mutations in RNA extracted from tissue samples to guide MET inhibitor therapy in NSCLC.
• MET Gene Amplification Detection Kit PCR assay for detecting MET gene amplification across pan-solid tumors, primarily lung cancer, to identify patients for MET-targeted therapy.
• HER2 Gene Amplification Detection Kit (dPCR) Digital PCR assay for detecting HER2 gene amplification in breast and gastric cancers to guide HER2-targeted therapy selection.
• AR-V7 Mutation Detection Kit Digital PCR assay for detecting AR-V7 androgen receptor splice variant 7 in prostate cancer patients to predict resistance to abiraterone and enzalutamide therapy.
• Human JAK2-V617F Mutation Detection Kit (qPCR) ARMS-PCR assay for detecting JAK2 V617F and Exon 12 mutations along with CALR and MPL mutations for myeloproliferative neoplasm (MPN) diagnosis and classification.
• Pan-solid Tumor 95-gene Mutation Detection Kit (MiniCDx) NGS panel using hybridization capture technology to detect point mutations, insertions/deletions, copy number variations, and fusions across 95 genes in solid tumors for targeted therapy guidance.
• HEMECDx Panel Kit High-throughput NGS assay for detecting 505 gene mutations (DNA) and transcriptome analysis in leukemia and lymphoma patients for diagnosis, prognosis stratification, and treatment guidance.
• HemeMRD Kit B cell receptor (BCR) sequencing panel for detecting B lymphocyte receptor gene rearrangements to assess minimal/measurable residual disease (MRD) in B-ALL, MM, and CLL patients.
• Med1CDx Panel Kit Comprehensive NGS panel covering 601 tumor-related genes including all FDA-approved FoundationOne and MSK-IMPACT panel genes for TMB, MSI, TNB analysis and immunotherapy guidance across all solid tumors.
• OncoCDx Panel Kit Pan-solid tumor NGS panel for detecting 191 tumor-related gene mutations including point mutations, insertions/deletions, copy number variations, and fusions for targeted therapy, chemotherapy, and immunotherapy guidance.
• HRDetectCDx Panel NGS panel based on 41,000+ SNPs to calculate Genomic Instability Score (GIS) by analyzing LOH, TAI, and LST for homologous recombination repair deficiency (HRD) assessment and PARP inhibitor guidance.
• Custom Products for FGFR Inhibitor Research (panFGFx) Customizable NGS panel focused on FGFR1-4 genes, upstream FGF ligand genes, and downstream pathway genes for FGFR inhibitor biomarker research and companion diagnostic development.
• Detection of Blood Cancer Gene Mutation Comprehensive genomic (DNA) and transcriptome (RNA) analysis panel for leukemia and lymphoma covering 505 gene mutations for diagnosis, prognostic stratification, targeted therapy, and recurrence monitoring.
• Translational Science Services Integrated translational medicine services for pharmaceutical sponsors covering biomarker discovery, target validation, patient stratification, and clinical translation of drug programs across genomics, proteomics, cytomics, and pathology platforms.
• Clinical Trials Services Central laboratory services for pharmaceutical clinical trials including biomarker discovery and validation, PK/PD/ADA bioanalysis, supported by molecular, bioanalysis, cell biology, and pathology centers.
• Companion Diagnostics Development Services End-to-end CDx/IVD product development from R&D through registration including NMPA/FDA/CE standards compliance, ISO 13485 quality systems, and commercialization support for pharmaceutical sponsors.

Quantifiable outcome

• 20+ products approved by drug administrations covering solid tumors and blood tumors
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core and minor.

• IlluminacoreTechnology or Integration · 23 November 2023Strategic partnership for pharmaceutical company service collaboration using Illumina TruSight Oncology 500 (TSO500) products. Dr. Pang Zhenguo from MEDx shared pharmaceutical company service experience at Illumina's Medical Innovation Series Salon. MEDx has accumulated rich experience in Sino-US joint clinical programs for innovative drugs using Illumina platforms including NovaSeq 6000, HiSeq XTen, and NextSeq 500.
• AbcamcoreOEM/ Whitelabel/ Licensing Partner · 1 October 2023MEDx obtained global authorization from Abcam, a leading antibody supplier, enabling use of Abcam antibodies in MEDx's diagnostic product development.
• China-Australia Biomedical Innovation CenterminorStrategic or Co-development Partner · 1 January 2022Collaborative partnership established between MEDx and Australia for biomedical innovation, supporting international research and development collaboration.
• Junshi BiosciencescoreStrategic or Co-development PartnerInnovative co-development partnership for companion diagnostics. MEDx partnered with Junshi Biosciences in co-development of companion diagnostic products for their pharmaceutical pipeline.
• QIAGENminorOthersMEDx was formerly known as QIAGEN (Suzhou) Translational Medicine Co., Ltd. The company was established in 2013 as the Translational Medicine Research Center of QIAGEN China before becoming independent.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Foundation Medicine (Roche): Roche-owned leader in NGS-based CDx (FoundationOne CDx) partnered with most large pharma oncology programs; competes with MEDx's NGS panels (Med1CDx, OncoCDx) for global pharma CDx mandates.
• Agilent Technologies: Provides CDx development services (Resolution Bioscience) plus pathology/IHC solutions; comparable in the IHC and CDx co-development services MEDx sells into pharma.
• Thermo Fisher Scientific: Diversified life sciences giant offering Oncomine NGS CDx assays plus PPD clinical trial services; directly comparable in both IVD/CDx products and central-lab clinical trial support.

Direct peers

• Geneseeq Technology: NGS-based cancer diagnostics company with pharma services and CDx development in China; comparable in NGS panel offerings and pharma co-development model.
• Genetron Health: Chinese precision oncology company offering NGS-based CDx and clinical testing across solid tumors and hematologic malignancies, directly overlapping with MEDx's NGS panels and clinical testing services.
• QIAGEN: Global leader in sample technologies and companion diagnostics with broad pharma CDx partnerships; most directly comparable as MEDx's former parent and a benchmark for the CDx development and commercialization model MEDx pursues.
• Novogene: China-headquartered genomics services and CDx provider operating Illumina and other NGS platforms; directly comparable in pharma sequencing services and CDx development.
• Burning Rock Biotech: China-based NGS oncology testing and CDx company with pharma partnerships and NMPA approvals; direct competitor in Chinese precision oncology CDx for solid tumors.

Emerging players

• Singlera Genomics: China-based precision diagnostics company focused on NGS cancer panels and CDx development; comparable in NGS-based assay portfolio and pharma CDx co-development services.
• 3D Medicines: Chinese precision oncology company developing NGS-based CDx and molecular diagnostics for pharma partners; comparable in CDx co-development for oncology drug pipelines.

Market position

Strengths5 records

Weaknesses6 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/medxtmc
• YouTubeyoutube.com/channel/UC39D--317SDuD1Wcs0P6G3w
• Facebookfacebook.com/Medx-105197125557356
• LinkedInlinkedin.com/company/%E8%BF%88%E6%9D%B0%E5%8C%BB%E5%AD%A6

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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

M&A

Investments

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

Frequently asked questions about MEDx