What Shuwen Biotech does

Shuwen Biotech (数问生物 / Zhejiang Shuwen Biotechnology Co., Ltd.) is a privately held Chinese diagnostics company founded in 2010 in Deqing, Zhejiang, by Jay Z. Zhang, former Senior Vice President at Myriad Genetics. The company develops and commercializes in vitro diagnostic (IVD) products and laboratory services focused on women's health, with primary franchises in breast cancer precision medicine and maternal-fetal medicine, and a secondary franchise in reproductive tract infection diagnostics. Shuwen also operates a CAP-accredited central laboratory (Guanz Diagnostic Laboratories) offering biomarker testing and companion diagnostics development to pharmaceutical sponsors and clinical trial operators.

The company's technology portfolio spans molecular diagnostics (RT-qPCR, multiplex real-time PCR, NGS), immunochemistry, and point-of-care testing, anchored by 100+ exclusive diagnostic patents and strategic inbound licenses from Yale University (misfolded-protein biomarker for preeclampsia), Fudan University Shanghai Cancer Center (Fudan Subtyping for triple-negative breast cancer), Max Planck Institute and Cologne University (theranostic biomarkers), and BioNTech Diagnostics (MammaTyper RT-qPCR platform). Flagship products include MammaTyper (RT-qPCR-based breast cancer molecular subtyping per St Gallen guidelines), EndoPredict (multi-gene prognostic test), FOXCARD (TNBC subtyping via AR/CD8/FOXC1/DCLK1), CapCord (professional-use preeclampsia test), and CercaTest RED (the world's first home-use preeclampsia test). The portfolio is supported by 40+ peer-reviewed clinical studies and 1,500+ patient-level data published in journals including JNCI, CCR, and JAMA Oncology.

Shuwen operates an integrated hub-and-spoke go-to-market model: direct hospital and lab sales in China through wholly-owned subsidiaries in Hangzhou (R&D center), Xuancheng (ISO13485 manufacturing), Jinhua (Lingzuo Medical for tumor and reproductive infection lines), and Deqing (headquarters plus central lab); international commercialization through Cerca Biotech GmbH, the Berlin-based European subsidiary covering 50+ countries; and channel partnerships with global IVD leaders including Sysmex (MammaTyper in 20+ countries across Europe and Africa), PerkinElmer (preeclampsia kits outside China), and Devyser Diagnostics (BRCA NGS kits in China). The company generates revenue across four streams — IVD product sales, central lab biomarker testing services, international licensing and distribution partnerships, and pharma services/companion diagnostics — though it has not publicly disclosed revenue figures. Multiple products hold NMPA Class III or Class II registration, CE marks, and clinical consensus inclusion in Chinese provincial guidelines.

Name

Shuwen Biotech

Legal name

浙江数问生物技术有限公司 (SHUWEN BIOTECH CO., LTD)

Website

https://shuwendx.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

1–10 employees

Short description

Shuwen Biotech is a Chinese women's-health diagnostics company developing IVD products and central lab services for breast cancer precision medicine, maternal-fetal medicine, and reproductive tract infections, commercialized across 50+ countries through direct sales, distributors, and partners like Sysmex and PerkinElmer.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

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

akta.pro primary industry

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

akta.pro secondary industries

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Genomics & Molecular Diagnostics (Trial Support) (HLAGAEAD)

Keywords

• Molecular diagnostics
• Breast cancer subtyping
• Preeclampsia screening
• Women's health IVD
• Companion diagnostics

Headquarters

HQ city

Deqing

HQ country

China

HQ region

Asia

Offices5 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Product Sales: Sale of in vitro diagnostic kits and instruments including molecular diagnostics (MammaTyper, EndoPredict, RDS, MTHFR), immunodiagnostics (FOXCARD, PD-L1), and point-of-care tests (CapCord, CercaTest RED). Products are sold directly and through distributors in China and internationally via Cerca Biotech.
2. Central Lab Testing Services: CAP-accredited central laboratory offering biomarker testing services to pharmaceutical developers and hospitals. Shuwen Guanz Diagnostic Laboratories provides companion diagnostics development and clinical trial sample testing.
3. International Licensing and Distribution Partnerships: Products licensed to international partners (e.g., PerkinElmer for preeclampsia kits outside China, Sysmex for MammaTyper in Europe/Africa). Revenue generated through licensing fees and product supply to partners.
4. Pharma Services and Companion Diagnostics: Provision of biomarker testing services and companion diagnostics development to pharmaceutical companies for drug development and clinical trials.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels5 records

Core offering

Shuwen Biotech develops, manufactures and commercializes proprietary in vitro diagnostic (IVD) kits and instruments for women's health, focused on breast cancer molecular subtyping (MammaTyper, EndoPredict, FOXCARD, QB Series, RDS, maxBRCA) and preeclampsia prediction (CapCord / CercaTest RED) using technologies that span RT-qPCR, NGS, immunochemistry and point-of-care urine biomarkers. It also operates a CAP-accredited central lab providing companion-diagnostics and clinical-trial biomarker testing services, distributing internationally via Cerca Biotech GmbH and partners including Sysmex, PerkinElmer and Devyser.

Product overview

Shuwen Biotech offers an integrated diagnostic portfolio focused on women's health, encompassing molecular diagnostics, immunodiagnostics, and point-of-care testing products. The core molecular diagnostic lineup includes MammaTyper® (RT-qPCR breast cancer subtyping), EndoPredict® (问谱特®) (multi-gene prognostic test), FOXCARD® (问复析®) (TNBC subtyping), and the QB™ Series (问汝®系列) multi-gene panels for breast cancer treatment guidance. Point-of-care offerings feature CapCord® (问娴安®) and CercaTest RED® (娴宫主®), the world's first home-use preeclampsia tests detecting urine misfolded proteins. Supporting products include PD-L1 immunohistochemistry reagents, MTHFR gene detection, RDS® gene profiling, nucleic acid extraction kits, and NAP-T8 automated extractor. The company operates through subsidiaries including Cerca Biotech GmbH (Germany) for international markets and Guanz Diagnostic Laboratories for central lab services.

Differentiator

Problem solved

Functional benefit

Brands

• MammaTyper (妈妈泰谱): Molecular diagnostic test for breast cancer subtyping using RT-qPCR to quantify ER, PgR, HER2, and Ki-67 biomarkers
• FOXCARD (问复析)
• EndoPredict (问谱特)
• CapCord (问娴安)
• CercaTest RED (娴宫主)
• maxBRCA
• QB Series (问汝)

Products and services

• MammaTyper® (妈妈泰谱®) RT-qPCR-based molecular diagnostic kit for quantitative determination of four key breast cancer biomarkers (ER, PgR, HER2, Ki-67) used to molecularly subtype breast cancer according to St Gallen guidelines; China NMPA Class III certified and CE marked; intended for hospital pathology and oncology laboratories.
• EndoPredict® (问谱特®) Second-generation multi-gene expression profiling test for prognostic prediction of breast cancer; assesses 10-year distant recurrence risk and predicts chemotherapy benefit in ER-positive, HER2-negative early breast cancer patients; for hospital and clinical laboratory use.
• FOXCARD® (问复析®) Immunohistochemistry-based AR/CD8/FOXC1/DCLK1 antibody combination test that subtypes triple-negative breast cancer (TNBC) to guide precision treatment selection; intended for hospital pathology laboratories.
• CapCord® (问嫗安®) Point-of-care diagnostic kit for quantitative detection of misfolded proteins in pregnant women's urine to aid prediction and diagnosis of preeclampsia; non-invasive with turnaround time under 3 minutes; for professional clinical use in hospitals, clinics and OB/GYN departments.
• CercaTest® RED (姗宫主®) World's first home-use urine-based preeclampsia self-test kit using the misfolded-protein biomarker, with results in approximately 5 minutes; CE marked and China NMPA approved for both professional and home-testing use; the home-use format is sold directly to pregnant women through the Shuwen e-commerce storefront.
• QB™ Series (问汝®系列) Family of multi-gene breast cancer testing panels for treatment guidance and hereditary risk assessment, including QB23 (23 genes), QB42 (42 genes), QB56 (56 hereditary genes), QB103, QB149, QB205 and QBPlus; used in hospital and clinical laboratory settings.
• PD-L1 Antibody Reagent Immunohistochemistry-based PD-L1 protein expression detection kit used for immunotherapy guidance across non-small cell lung cancer, gastric cancer, triple-negative breast cancer, bladder cancer and nasopharyngeal cancer; intended for hospital pathology laboratories.
• MTHFR Gene Detection Reagent NMPA Class III-certified PCR kit for the detection of MTHFR 677 gene polymorphism to assess folate metabolism and guide personalised folic acid supplementation for the prevention of birth defects; used in maternal-fetal medicine and reproductive health settings.
• RDS® Gene Detection Multi-gene PCR-based expression profiling test that measures DNA repair pathway gene expression to predict response to DNA-damaging chemotherapy in ER-negative breast cancer; intended for hospital oncology and pathology laboratories.
• maxBRCA™ Next-generation sequencing-based BRCA1/2 gene testing service capable of detecting point mutations, insertions/deletions, copy number variations and large genomic rearrangements; offered as a laboratory-developed test through Shuwen's CAP-accredited central labs and Devyser partnership.
• AMR Testing Technology (Gonococcal Drug Resistance Detection) Proprietary molecular assay for rapid (1-2 hour) detection of antimicrobial resistance in gonococcal infections without the need for prior culture, supporting real-time AMR surveillance networks and antibiotic selection by clinicians and public health laboratories.
• Central Lab Biomarker Testing and Companion Diagnostics Service (Shuwen Guanz Diagnostic Laboratories) Central laboratory service offering companion-diagnostics development, biomarker testing and clinical-trial sample analysis for pharmaceutical companies and hospitals; the lab is CAP-accredited and operates under Shuwen's Guanz Diagnostic Laboratories entity in Deqing.

Quantifiable outcome

• CercaTest RED demonstrated AUC 0.937 (95% CI 0.911-0.964) in predicting preeclampsia within one week of clinical diagnosis, with NPV 97.7%, in a multicenter prospective study of 365 patients.
• +3 more outcomes

Named customers2 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

Feature5 records

Partnerships

Eight partnerships are on record, tiered major and core.

• SysmexmajorChannel Partner/ Reseller/ Distributor · 1 January 2024Global IVD giant Sysmex partnered with Shuwen to promote MammaTyper in over 20 countries across Europe and Africa.
• Fudan University Shanghai Cancer Center (FUSCC)coreStrategic or Co-development Partner · 7 March 2023Shuwen acquired patents for 'Fudan Subtyping' TNBC molecular classification technology from FUSCC and formed a research collaboration with the center to develop and commercialize the technology. FUSCC is the world's largest breast cancer treatment center. The technology classifies TNBC into four subtypes with demonstrated ORR improvements in clinical trials.
• Devyser Diagnostics ABmajorChannel Partner/ Reseller/ Distributor · 7 March 2022Distribution agreement where Shuwen distributes Devyser BRCA NGS and other oncology kits in China and offers testing and NGS data analysis services with Devyser kits in its CAP-accredited clinical labs.
• BioNTech Diagnostics AGcoreStrategic or Co-development Partner · 10 November 2021Asset purchase agreement where Shuwen's subsidiary Near Biotech acquired MammaTyper molecular diagnostic rights and RNXtract nucleic acid extraction kit from BioNTech for worldwide development and commercialization. Near Biotech had worked with BioNTech for 5 years in development and commercialization before acquiring the full rights.
• Myraid GeneticsmajorStrategic or Co-development Partner · 1 January 2021Exclusive strategic partnership with Myraid Genetics for EndoPredict breast cancer prognostic test, introduced to China market by Shuwen as 问谱特®.
• PerkinElmercoreChannel Partner/ Reseller/ Distributor · 1 January 2020PerkinElmer licensed global rights (outside China) for Shuwen's preeclampsia detection kits (CapCord/CercaTest RED) for worldwide maternal and infant diagnostic distribution. Described by McKinsey as 'a typical representative of the new era of global cooperation for Chinese companies in the medical technology industry.'
• Yale UniversitycoreTechnology or Integration · 1 January 2010Exclusive patent license agreement with Yale University for novel misfolded protein biomarker in maternal fetal medicine, used as the foundation for Shuwen's world-first preeclampsia detection kits (CapCord/CercaTest RED). Developed based on discoveries by Professor Irina Buhimschi.
• Max Planck Institute and Cologne UniversitymajorTechnology or Integration · 1 January 2010Exclusive patent license agreement with Max Planck Institute and Cologne University for novel theranostic biomarkers.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Exact Sciences: Exact Sciences owns Oncotype DX Breast Recurrence Score, the dominant genomic test that MammaTyper LRP directly challenges at ~10% of the cost. Both companies target ER+/HER2- breast cancer prognostic testing with the same end-decision (chemotherapy benefit) and overlap on Oncotype DX alternative positioning globally.
• NanoString Technologies: NanoString's Prosigna (PAM50) is a multiplex gene-expression breast cancer subtyping assay that competes head-to-head with MammaTyper in the molecular subtyping and recurrence risk category. Both target hospital pathology labs with standardized, objective biomarker quantification versus IHC.
• Myriad Genetics: Myriad pioneered BRCA1/2 testing (BRACAnalysis) and HRD testing in breast/ovarian cancer — the same high-margin hereditary cancer testing niche Shuwen targets with maxBRCA NGS and QB hereditary panels. Shuwen's founder was formerly SVP at Myriad, and the companies share an EndoPredict distribution partnership.
• Veracyte: Veracyte is a molecular diagnostics company focused on oncology subtyping (Afirma for thyroid, Decipher Prostate, Percepta for lung) using proprietary genomic classifiers — directly comparable business model to Shuwen's portfolio of subtyping tests across breast cancer, TNBC, and reproductive infections.
• Natera: Natera operates in women's health molecular diagnostics with Panorama NIPT, Empower hereditary cancer, and Vistara single-gene NIPT — directly comparable to Shuwen's maternal/fetal health and reproductive tract infection segments, including the CapCord/CercaTest RED preeclampsia franchise.

Broad incumbents

• Hologic: Hologic is a broad women's health diagnostics incumbent with a large installed base of mammography, HPV, and molecular assays. Its Diagnostics division (formerly Gen-Probe/Diagenode) competes with Shuwen's IVD portfolio for hospital lab budget and has substantially greater sales coverage in the US and Europe.
• Roche Diagnostics: Roche operates a global molecular diagnostics and IVD platform (cobas, Foundation Medicine, digital PCR) that competes broadly with Shuwen's MammaTyper and QB series in hospital and central lab settings. As the largest diagnostics player globally, Roche sets pricing, distribution, and clinical guideline dynamics that constrain smaller molecular dx challengers.
• Abbott Diagnostics: Abbott's diagnostics arm includes molecular, immunoassay, and point-of-care platforms (m2000, Alinity, i-STAT) that compete for the same hospital and reference lab budgets as Shuwen's products. Abbott's broad portfolio and global field sales force makes it a benchmark competitor in every region Shuwen operates.
• Qiagen: Qiagen is a global leader in sample-prep and molecular diagnostic kits (QIAstat-Dx, QIAsymphony, therascreen companion diagnostics) that overlap with Shuwen's RT-qPCR kits, NGS companion diagnostics, and nucleic acid extraction products. Qiagen's deep pharma companion-Dx relationships are directly comparable to Guanz Lab's pharma services business.

Emerging players

• Devyser Diagnostics: Devyser is a smaller Swedish molecular diagnostics company specializing in BRCA and hereditary cancer NGS kits, which Shuwen distributes in China under a 2022 partnership. Both companies focus on niche oncology and reproductive genetic testing with similar product-portfolio breadth and target customer profile (hospital molecular labs).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@CercaBiotech
• LinkedInlinkedin.com/company/biotech-co.

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries6 records

Funding overview

Funding rounds4 records

Investors8 records

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 Shuwen Biotech