A Precision Diagnosis Technology And Product Innovation Company Focusing On Women's Health
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
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"
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"
Shuwen Biotech was recognized as a National High-Tech Enterprise
Completed A+ round of financing with a leading pharm company
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
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
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
Shuwen Guanz Diagnostic Laboratories Co. Ltd. was established and received operating license from health authorities to offer diagnostic services
Completed seed financing
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
