What AnchorDx does

AnchorDx is a precision medicine company headquartered in Guangzhou, China, founded in 2015. The company develops liquid biopsy tests based on cell-free DNA (cfDNA) and circulating tumor DNA (ctDNA) methylation sequencing for early cancer detection, with products built on a "one tube of blood" or "one tube of urine" sample workflow. Its commercial lead product is UriFind, a urine-based test for bladder and urothelial cancer, supported by PulmoSeek Plus for lung cancer and an expanding pipeline covering gastric (Gastromia) and breast cancers, plus a Twist Bioscience-enabled pan-cancer product.

The underlying technology stack combines wet-lab methylation sequencing with proprietary AI-driven classification. AnchorDx operates four named technology platforms — AnchorIRIS, AnchorViola, AnchorMonarch, and DeepMeth — supporting methylation profiling, NGS-based sequencing, bioinformatics analysis, and machine-learning-based cancer classification. The company maintains two R&D centers (Guangzhou, China, and Fremont, California) and two GMP/ISO 13485-certified production facilities. It has filed 82 patent applications with 32 granted, and its PulmoInsight algorithm was trained on more than 20,000 cases and presented at AAAI 2022.

Commercially, AnchorDx operates a hybrid business model: B2B sales of IVD kits to tertiary hospitals (100+ hospitals for UriFind, 94 for PulmoSeek Plus), laboratory-developed test (LDT) services through its own lab, and a direct-to-consumer (DTC) testing service that has cumulatively served over 100,000 people. Revenue mechanics are split across IVD kit unit sales, per-test LDT fees, and DTC test pricing. The company holds NMPA Class III IVD approval (Feb 2024), FDA Breakthrough Device Designation (July 2021), and EU CE Mark, and is pursuing a US PMA trial. It has raised approximately $83M cumulatively, including a $40M Series C in 2021, and entered a global distribution partnership with DiaCarta in February 2024.

Name

AnchorDx

Legal name

广州市基准医疗有限责任公司 (Guangzhou AnchorDx Medical Co., Ltd.)

Website

https://anchordx.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

51–100 employees

Short description

AnchorDx is a Guangzhou-based precision medicine company developing ctDNA and cfDNA methylation-based liquid biopsy tests for early cancer detection, serving hospitals and patients across bladder, urothelial, lung, breast, and gastric cancer indications in China and globally.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

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

Single-Cell & Spatial Omics Discovery Platforms (target ID/validation, functional profiling) (HLAAAIAF), Cytology & Histopathology Diagnostics (IHC, ISH, tissue-based assays) (HLAAALAI), Molecular Pathology & Tissue Biomarkers (IHC/ISH, digital pathology-linked markers) (HLAAAMAI), Multi-Omics Precision Medicine Platforms (genomics/proteomics/metabolomics) (HLAAANAF), Epigenomics & Chromatin Profiling Services (HLAGANAF), Cellomics & High-Content Screening (HCS) Services (HLAGANAD), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

Keywords

• Cancer early detection
• DNA methylation diagnostics
• Liquid biopsy tests
• IVD reagent kits
• Clinical laboratory services

Headquarters

HQ city

Guangzhou

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Reagent Kit Sales (UriFind®): Sale of the "Human ONECUT2/VIM Gene Methylation Test Kit (Fluorescent PCR Method)" (国械注准20243400221), China's first NMPA Class III-approved IVD kit for urothelial cancer auxiliary diagnosis, launched in early 2024. Distributes via commercial channels to hospitals and clinical labs in China. One-time product/license sale per unit.
2. Clinical Laboratory Testing Services (LDT): AnchorDx Clinical Laboratory (Guangzhou), established 2016, performs DNA methylation-based early cancer detection testing services (LDT mode) for lung, bladder, urothelial, and other cancers. Authorized in 2017 to apply high-throughput sequencing to clinical applications (one of the first such approved labs in China). Per-test service revenue from hospitals, clinicians, and direct consumers.
3. Direct-to-Consumer Cancer Screening Tests: Online/offline ordering of UriInstant™ (尿立检) and UriFind® (泌益检) urine-based bladder cancer screening and diagnostic products, with home self-sampling kits and 100ml urine collection; includes report interpretation and follow-up services. Per-test usage-based revenue from individual consumers.
4. Global Out-licensing and Co-Commercialization: Long-term partnership with DiaCarta for joint development and global commercialization of cancer screening products in the U.S. and other markets. Generates licensing royalties, milestone payments, and/or co-commercialization revenue as UriFind® and other products proceed through U.S. PMA and ex-China approvals.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels8 records

Core offering

AnchorDx is a precision medicine company that develops and commercializes DNA methylation-based in-vitro diagnostic (IVD) kits and laboratory-developed tests (LDT) for non-invasive early detection of cancer. Its portfolio covers more than 70% of high-incidence cancers through "a tube of blood" products (e.g., PulmoSeek Plus for lung nodules) and "a tube of urine" products (e.g., UriFind for urothelial carcinoma and UriInstant for bladder cancer screening), supported by its in-house clinical laboratory and AI imaging tools. The company is anchored by three proprietary technology platforms — AnchorIRIS methylation library prep, AnchorViola somatic mutation library prep, and AnchorMonarch methylation analysis software — combined with the DeepMeth deep-learning model and PulmoInsight CT AI.

Product overview

AnchorDx (广州市基准医疗有限责任公司) operates a single integrated cancer-early-detection platform built on two diagnostic "lines" — "a tube of blood" and "a tube of urine" — that together cover more than 70% of high-incidence cancers. The portfolio is unified by three proprietary technology pillars — AnchorIRIS® (methylation library prep), AnchorViola® (somatic-mutation library prep) and AnchorMonarch® (AI-driven methylation analysis software) — and is delivered through three product families: (1) the Respiratory / Lung-nodule line, led by the flagship PulmoSeek™ Plus (费益检®) blood-based methylation + CT-imaging AI test, complemented by PulmoPath™ (费镜检™) for bronchoalveolar lavage and PulmoInsight™ (费影检™) for CT-imaging AI; (2) the Urinary / Urothelial-cancer line, led by UriFind® (泌益检™) — China's first NMPA-approved IVD for urothelial cancer auxiliary diagnosis (Class III, Feb 2024) — and the early-screening test UriInstant™ (尿立检™); and (3) the Digestive / Gastric-cancer pipeline, anchored by Gastromia™ (胃易检). AnchorDx also co-developed a pan-cancer methylation assay with Twist Bioscience, runs the AnchorDx Clinical Laboratory for centralized LDT service, and uses its Guangzhou International Bio Island facilities plus a US R&D center in Fremont, California, to drive both domestic commercialization and global registration.

Differentiator

Problem solved

Functional benefit

Brands

• PulmoSeek™ Plus (费益检®): Non-invasive liquid biopsy combined with CT imaging AI to distinguish benign and malignant pulmonary nodules. ctDNA methylation-based diagnostic product.
• UriFind® (泌益检™)
• UriFind™ / UriInstant™ (尿立检™)
• PulmoPath™ (费镜检™)
• PulmoInsight™ (费影检™)
• Gastromia™ (胃易检)
• AnchorIRIS®
• AnchorViola®
• AnchorMonarch®

Products and services

• UriFind® (泌益检) — Human ONECUT2/VIM Gene Methylation Test Kit A urine-based DNA methylation test (ONECUT2/VIM gene methylation, fluorescent PCR method) for non-invasive auxiliary diagnosis of urothelial carcinoma (bladder, ureteral, and renal pelvis cancers). Requires 100 ml of random urine. NMPA Class III-approved, US FDA Breakthrough Device Designation, EU IVDD CE Mark. Sold to hospitals and clinical labs in China and to global partners.
• UriInstant™ (尿立检) — Urothelial Cancer Early Screening Test Non-invasive urine-based genetic test for early screening of urothelial tumors covering three urinary tract cancers (bladder urothelial carcinoma, renal pelvis carcinoma, ureteral carcinoma). Designed for at-home self-sampling. Performance validated in approximately 20,000 real-world cases. Available through hospital orders and direct-to-consumer online/offline ordering.
• PulmoSeek™ Plus (费益检®) — Pulmonary Nodule Benign/Malignant Test Non-invasive liquid biopsy test combining 10 ml peripheral blood ctDNA methylation (NGS) with chest CT-imaging AI to differentially diagnose benign vs malignant pulmonary nodules of 5–30 mm. Sensitivity 98.1%, specificity 91.7%, accuracy 97.3%. Sample: 10 ml blood + CT-DICOM data. ISO 13485:2016 certified; EU IVDD CE Mark. Sold to hospitals, with direct-to-consumer ordering available.
• PulmoPath™ (费镜检™) — Early Lung Cancer BALF/Biopsy Methylation Test Early lung cancer auxiliary methylation test for bronchoalveolar lavage fluid (BALF) and biopsy tissue samples, designed to improve the diagnostic yield of bronchoscopy and percutaneous lung biopsy. Sensitivity 84.1%, positive predictive value 92.5%. Co-developed with West China Hospital, Sichuan University.
• PulmoInsight™ (费影检™) — AI Lung Nodule CT Imaging Analysis CT-imaging AI software that automatically detects, segments, tracks, and risk-stratifies pulmonary nodules. Trained on 20,000+ pathologically confirmed lung nodule CT cases. Reports 95% detection rate, approximately 30-second automated analysis, and 0.001 mm³ volume precision. Accepts CT-DICOM input; intended for pulmonary nodule patients and LDCT screening populations.
• AnchorDx Clinical Laboratory (Guangzhou) — LDT Clinical Testing Service High-standard clinical laboratory on Guangzhou International Bio Island performing DNA methylation-based cancer early-screening and early-diagnosis testing services for lung, bladder, urothelial, and other cancers. Has passed NCCL/CAP proficiency testing for six consecutive years. Serves hospitals, clinicians, and individual consumers.
• Gastromia™ (胃易检) — Gastric Cancer Non-invasive Methylation Assay Non-invasive blood-based ctDNA methylation assay for early detection of gastric cancer built on a 7-marker methylation panel. Overall sensitivity 87.3%, specificity 66.2%, 99.6% NPV at 2% prevalence, 80% sensitivity for early-stage gastric cancer. Co-developed with Guangdong Provincial People's Hospital and Southern Medical University.
• Twist–Anchor Methylation Pan-Cancer Detection Product Pan-cancer cfDNA methylation high-throughput sequencing assay co-developed with Twist Bioscience, launched globally. Combines Twist's silicon-chip DNA synthesis platform with AnchorDx's methylation wet lab and AI capabilities.

Quantifiable outcome

• PulmoSeek Plus: 98.1% sensitivity, 91.7% specificity, 97.3% accuracy for pulmonary nodule benign/malignant classification
• +9 more outcomes

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability9 records

Feature6 records

Partnerships

13 partnerships are on record, tiered flagship and core.

• DiaCarta (帝基生物)flagshipStrategic or Co-development Partner · 1 February 2024Long-term collaboration between AnchorDx and DiaCarta (Pleasanton, CA) for joint product development and global commercialization of cancer screening tests, leveraging complementary DNA methylation (AnchorDx) and mutation detection (DiaCarta QClamp®, XNA-NGS OptiSeq™) technologies. DiaCarta is also a clinical testing laboratory in AnchorDx's U.S. UriFind® PMA registrational trial (NCT05643690). The partnership is part of AnchorDx's stated strategy to accelerate global commercialization of UriFind® and future cancer screening products.
• U.S. Urology and Clinical Centers (10 sites) + 3 CAP/CLIA laboratories for UriFind® PMA trialcoreImplementation/ SI/ Consulting Partner · 1 January 2023AnchorDx's U.S. registrational clinical trial (NCT05643690) for UriFind® PMA application plans to enroll more than 1,000 patients across 10 urology centers and 3 CAP/CLIA-certified laboratories (DiaCarta is one of them), with first patient enrolled. Trial results will be submitted to the U.S. FDA for Premarketing Approval.
• Twist Bioscience (拓唯思特, NASDAQ: TWST)coreStrategic or Co-development Partner · 1 February 2022Joint development and global launch (Sept 24, 2021, U.S. time) of the "Twist–AnchorDx Methylation Pan-Cancer Detection" product. Subsequent Guangzhou Huangpu District International Science & Technology Cooperation project (up to ¥2M funding) titled "Development and Application of an AI-Assisted Diagnostic System Based on Liquid Biopsy cfDNA Methylation High-Throughput Sequencing for Pan-Cancer Detection". The partnership leverages Twist's silicon-chip DNA synthesis platform with AnchorDx's methylation wet lab and AI capabilities.
• Guangdong Provincial People's HospitalcoreStrategic or Co-development Partner · 1 January 2022Co-participant in the "R&D and Application of Lung Cancer Precision Early Screening Technology" project, awarded ¥5M of funding in the 2022 Guangzhou Key R&D Program Health Care Major S&T Special Project (led by Guangzhou Medical University First Affiliated Hospital).
• West China Hospital, Sichuan University (刘丹/李为民 Professor team)coreStrategic or Co-development Partner · 1 January 2021Joint development and clinical validation of the PulmoPath™ methylation test on bronchoalveolar lavage fluid (BALF) and biopsy tissue samples, achieving 84.1% sensitivity and 92.5% positive predictive value. Co-published in Clinical Epigenetics (2021, IF=7.259), and resulted in a 2022 patent application transfer agreement covering the co-developed IP.
• Harbin Medical University Cancer Hospital (庞达 Professor team)coreStrategic or Co-development Partner · 1 January 2021Joint breast cancer early diagnosis research program. Co-published a foundational Nature sub-journal paper in npj Breast Cancer (CAS Q1) on "Circulating cell-free DNA-based methylation patterns for breast cancer diagnosis", and presented a 2022 SABCS poster on the combined breast ultrasound + ctDNA methylation model for BI-RADS 4a patients (improved accuracy by 40.58%, reduced unnecessary biopsy/surgery by 43.47%).
• Johnson & Johnson (Lung Cancer Initiative / LCI)coreStrategic or Co-development Partner · 1 January 2020Co-led Angel Program (NCT04462185), a prospective observational study with 6 clinical centers enrolling 3,000 patients with indeterminate pulmonary nodules (5-30 mm). The collaboration was used to validate clinical, imaging, and molecular biomarkers in lung cancer and improve diagnostic efficiency for IPN patients. Obtained HGRAC approval in August 2020.
• IlluminacoreTechnology or Integration · 1 January 2019Strategic cooperation reached with Illumina (the global leader in genetic sequencing technology) in 2019. This complements the deep Illumina DNA of AnchorDx's R&D team, including founder Dr. Jianbing Fan (Illumina founding employee #23) and CSO Dr. Marina Bibikova (former Illumina chief scientist), both of whom helped build Illumina's BeadArray technology and the first FDA-certified high-throughput sequencing platform.
• Nankai University (南开大学)coreStrategic or Co-development Partner · 1 January 2019Jointly established the "Nankai University – AnchorDx Medical Data Research Center" in 2019. The center co-developed the DeepMeth deep-learning methylation representation model, accepted at AAAI'22 (the 36th AAAI Conference on AI), and is now deployed in 94+ hospitals in China for PulmoSeek Plus. The relationship underpins AnchorDx's AI+methylation research pipeline.
• Fred Hutchinson Cancer Research CentercoreStrategic or Co-development Partner · 1 January 2018Reached an exclusive patent licensing and cooperation agreement in 2018, expanding AnchorDx's methylation IP base and providing access to Fred Hutch's translational oncology expertise.
• Guangzhou Medical University First Affiliated Hospital / National Respiratory Medical Center (何建行/梁文华 Professor team)flagshipStrategic or Co-development Partner · 1 January 2017Long-term clinical research partnership co-developing the PulmoSeek and PulmoSeek Plus ctDNA methylation + CT AI products for pulmonary nodule benign/malignant classification. Led multi-center trials including NCT03181490 (PulmoSeek validation, 14 centers, 1,490 subjects) and the Thunder Project (NCT03651986, 23 centers, 10,560 subjects), and won a ¥5M Guangzhou R&D grant in 2022 for the "R&D and Application of Lung Cancer Precision Early Screening Technology" project.
• Zhong Nanshan (钟南山) / National Respiratory Medical Center – Thunder ProjectflagshipStrategic or Co-development Partner · 1 January 2017Académician Zhong Nanshan-led "Thunder Project" (NCT03651986), a prospective observational study with 23 clinical centers and 10,560 participants with 5-30 mm pulmonary nodules, designed to comprehensively evaluate the combined clinical, AI-assisted CT imaging, and NGS-based ctDNA methylation biomarker model. The project was launched in September 2018, completed enrollment in May 2021, and resulted in multiple peer-reviewed publications and conference presentations.
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University (黄健 / 林天歆 Professor team)flagshipStrategic or Co-development Partner · 1 January 2017Five-year collaboration (2017-2022) to develop the UriFind® urine DNA methylation diagnostic product. Resulted in two foundational journal publications (J Clin Invest 2020; Clin Epigenetics 2021) and the BC004 Program (NCT04314245), the first prospective, real-world, multi-center clinical study for urothelial cancer registered with the NIH by a Chinese company. The product led to NMPA Class III approval in 2024.

Scale indicators13 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• GRAIL: GRAIL's Galleri test is a methylation-based cfDNA multi-cancer early-detection assay; both companies compete in blood-based methylation cancer screening with overlapping KOL and guideline-endorsement strategies.
• Singlera Genomics: Singlera is a Chinese methylation-based cancer screening company (e.g., ColonES) and is one of the closest direct Chinese competitors to AnchorDx's blood-based early-detection platform.
• Genetron Holdings: Genetron offers NGS-based cancer screening and diagnostics in China, including methylation-based LDT products; competes directly with AnchorDx in the Chinese precision oncology early-detection segment.
• Freenome: Freenome is a multiomics (methylation + protein) blood-based multi-cancer screening developer; directly comparable as a privately held MCED peer leveraging ctDNA methylation.

Broad incumbents

• Guardant Health: Guardant360 and Guardant Reveal are liquid-biopsy oncology products; Guardant is a broader liquid-biopsy incumbent pursuing methylation-augmented multi-cancer detection, making it a key adjacency to AnchorDx's pipeline.
• Burning Rock Biotech: Burning Rock is a leading China NGS oncology company offering both cancer therapy selection and early-detection products; comparable to AnchorDx as a China oncology genomics peer with overlapping hospital sales channels.

Others

• Exact Sciences: Cologuard and Oncotype DX maker pursuing multi-cancer screening (Cancerguard MCED); a broad U.S. cancer screening incumbent whose methylation work overlaps with AnchorDx's approach.
• DiaCarta: DiaCarta is AnchorDx's U.S. co-development and global commercialization partner; it also independently develops QClamp®, OptiSeq™, and QuantiVirus™ molecular diagnostics, making it both a partner and a thematically adjacent molecular diagnostics peer.

Regional players

• Novogene: Novogene is a major China-headquartered NGS services and oncology genomics company; comparable as a Chinese sequencing-services peer with overlapping ctDNA sequencing capabilities.
• Berry Genomics: Berry Genomics is a leading Chinese genetic testing and cancer diagnostics company (NIPT pioneer expanding into oncology); comparable as a Chinese molecular diagnostics peer with hospital channel overlap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries2 records

Funding overview

Funding rounds3 records

Investors8 records

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M&A

Investments

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Frequently asked questions about AnchorDx