A Precision Diagnosis Technology And Product Innovation Company Focusing On Women's Health

2021

Launched EndoPredict® in the China market

EndoPredict® became recommended in the Breast Cancer Diagnosis and Treatment Guideline from the China Anti-Cancer Association (CACA)

Received NMPA class III registration approval for our qPCR kit for mutation detection in the MTHFR gene (C677T)

Launched maxBRCA , a proprietary NGS testing service for comprehensive analysis the BRCA1/2 genes featuring the capabilities of identifying large rearrangements

2020

Received NMPA class II registration approval for first-in-kind device for point-of-care diagnosis of pre-eclampsia (CapCord) in pregnant women

Collaboration agreement signed with PerkinElmer for marketing the pre-eclampsia POC diagnostic device in China

Designated as the International Cooperation Base for In Vitro Diagnostics in Zhejiang ProvinceR&D Center recognized as "High-Tech Enterprise R&D Center"

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2019

RDS projects were selected as key research and development projects in Zhejiang Province in 2019

Guanz Laboratory Center won the title of "Zhejiang Provincial International Science and Technology Cooperation Base"

2018

Shuwen Biotech was recognized as a National High-Tech Enterprise

Completed A+ round of financing with a leading pharm company

2017

The Xuancheng, Anhui Province branch was established as a production base for IVD kits in the field of maternal fetal medicine

Completed financing from a major investment fund in Shenzhen

2016

The Shuwen Guanz Diagnostic Laboratories received CAP accreditation from the College of American Pathologists, a first of such accreditation in a private lab in Zhejiang Province

Shuwen Biotech received ISO13485 certification

MammaTyper® received breakthrough product designation from the NMPA

Completed A round financing

2015

Signed collaboration agreement with BioNTech to co-develop MammaTyper®

Central lab received license for conducting PCR and genetic testing

Shuwen Health Co. Ltd. was established as a marketing arm for central lab LDT services

2014

Shuwen Guanz Diagnostic Laboratories Co. Ltd. was established and received operating license from health authorities to offer diagnostic services

Completed seed financing

2010-2013

Shuwen Biotech Co. Ltd. was founded in China by Jay Z. Zhang, former Senior VP of Myriad Genetics

Signed exclusive patent license agreement with Max-Planck Institute and Cologne University for novel theranostic biomarkers

Exclusive patent license agreement with Yale University for novel biomarkers in maternal fetal medicine

Initiated IVD product development in oncology and maternal fetal medicine

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