WOMEN HEALTH

BREAST CANCER

We offer one-stop shop for proprietary diagnostic kits and testing services covering the full spectrum of breast cancer precision medicine, ranging from breast cancer risk assessment to molecular subtyping, prediction, prognosis, and recurrence monitoring.

Diagnostics for Full Spectrum of Breast Cancer Precision Medicine

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risk assessment

maxBRCA™

Comprehensive and reliable BRCA1/2 mutation screening detecting not only point mutations and indels, but also large rearrangements in FFPE or blood samples, enabling PARPi treatment and genetic risk determination.

maxHBOC™

Screening of 14 genes implicated in hereditary breast cancer and ovarian cancer (HBOC) detecting not only point mutations and indels, but also large rearrangements in FFPE or blood samples.

QB56

Screening of mutations in 56 genes implicated in hereditary breast cancer and ovarian cancer (HBOC).

Coming soon...

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Precise screening

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subtyping

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

FOXCARD Fudan Subtyping

An IHC kit for subtyping triple negative breast cancer (TNBC) and guiding improved TNBC therapy. It is developed based on Fudan Subtyping proposed by Professor Zhiming Shao of Fudan University Cancer Hospital. Shuwen has acquired patents on the technology from the hospital and collaborates with Prof. Shao for its commercialization.

Prognosis and adjuvant therapy guidance

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

Neoadjuvant therapy

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

HER2-ADC therapy

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

CercaTest® ERBB2

a CE IVD proprietary kit that utilizes RT-qPCR technology to accurately and reproducibly measure the mRNA level of ERBB2 in FFPE samples of breast cancer, and may be a better selection tool for identifying patients suitable for treatment with Her2-ADC therapies.

CDK4/6 Inhibitor

Coming soon...

HER2+ inhibitor/antibody/ADC

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

CercaTest® ERBB2

a CE IVD proprietary kit that utilizes RT-qPCR technology to accurately and reproducibly measure the mRNA level of ERBB2 in FFPE samples of breast cancer, and may be a better selection tool for identifying patients suitable for treatment with Her2-ADC therapies.

IHC / FISH

Comprehensive evaluation of the sensitivity test of anti-HER2 targeted drugs such as trastuzumab.

Subtyping

FOXCARD™ Fudan Subtyping

An IHC kit for subtyping triple negative breast cancer (TNBC) and guiding improved TNBC therapy. It is developed based on Fudan Subtyping proposed by Professor Zhiming Shao of Fudan University Cancer Hospital. Shuwen has acquired patents on the technology from the hospital and collaborates with Prof. Shao for its commercialization.

Neoadjuvant therapy

RDS®

The RDS® Tumor DNA Recombination Repair Defect Assessment system is the first quantitative assay to independently predict prognosis and efficacy of DNA damaged therapies for ER negative breast cancer.

HER2-ADC

MammaTyper®

MammaTyper® is a standardised multiplex real-time qPCR assay co-developed by Shuwen and BioNTech (Germany). The assay kit allows pathologists to amplify, detect and quantify the mRNA expression status of 6 genes to most appropriately and accurately subtype breast cancer in the patients (as recommended by St Gallen, 2013 and subsequent updates).

CercaTest® ERBB2

a CE IVD proprietary kit that utilizes RT-qPCR technology to accurately and reproducibly measure the mRNA level of ERBB2 in FFPE samples of breast cancer, and may be a better selection tool for identifying patients suitable for treatment with Her2-ADC therapies.

PARP inhibitor therapy

maxBRCA™

Comprehensive and reliable BRCA1/2 mutation screening detecting not only point mutations and indels, but also large rearrangements in FFPE or blood samples, enabling PARPi treatment and genetic risk determination.

Immunotherapy

PD-L1/MSI/TMB

For PD-L1 staining and analysis, we offer a proprietary IHC kit we developed and registered in China. The kit has been extensively validated in various tumor types and has been used in testing tens of thousands of clinical trial samples for our pharmaceutical company clients.

We have also developed an LDT assay for MSI that offers accurate testing of MSI status in different tumor types.

maxBRCA™

Comprehensive and reliable BRCA1/2 mutation screening detecting not only point mutations and indels, but also large rearrangements in FFPE or blood samples, enabling PARPi treatment and genetic risk determination.

maxHBOC™

Screening of 14 genes implicated in hereditary breast cancer and ovarian cancer (HBOC) detecting not only point mutations and indels, but also large rearrangements in FFPE or blood samples.

HRD (Homologous recombination deficiency) & DDR (DNA damage response) testing

Gene instability scoring (GIS) by complexing heterozygous deletion (LOH), telomere allele imbalance (TAI), and large fragment migration (LST) using the next-generation sequencing approach; Evaluating homologous recombinant deficient status and screening PARP inhibitor-sensitive populations based on the GIS score (HRD score) and BRCA1/2 mutations and other 42-gene mutation(s) related to homologous recombinant repair (HRR).

QB42™ 

NGS exome sequencing of 42 genes relevant to therapy selections for patients with early stage breast cancer of Luminal type.

QB56™ 

56-gene hereditary breast cancer testing

Covering 56 genes related to hereditary breast cancer with two key genes BRCA1/2; Improving hereditary management decisions in high-risk populations, and providing clinical guidance in using PARP inhibitors.

QB103™

103-gene panel testing for personalized treatment of breast cancer

Examining relevant 103 genes in HR+ (hormone receptor positive) breast cancer using exome sequencing approach; Guiding targeted therapy, evaluating drug efficacy and toxic side effects of endocrine/chemotherapy drugs, and assisting in clinical hereditary management.

QB149™

149-gene panel testing for personalized treatment of breast cancer

Examining 149 relevant genes in HR-(hormone receptor negative) breast cancer using exome sequencing approach, including genes for breast cancer targeted therapy, chemotherapy, immunotherapy, and hereditary risk.

QB205™

205-gene comprehensive breast cancer testing

A package designed for precision diagnosis and treatment of breast cancer by sequencing 205 genes recommended by authoritative guidelines and consensuses worldwide, meeting demands of clinical testing, medication guidance or genetic risk screening management requirements for different breast cancer subtypes and stages including early and advanced breast cancer patients, Luminal type or triple-negative breast cancer patients.

680-gene comprehensive breast cancer testing

Fully meeting personalized needs of breast cancer targeted therapy, immunotherapy, endocrine therapy, and chemotherapy regimens.

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Customized strategy

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recurrence Monitoring

MRD

Coming soon...