IVD Kit Products

Shuwen has an initial focus on oncology and pregnancy-related conditions.  We strive to provide China with comprehensive diagnostics menus for each cancer type including tests for predisposition, screening, diagnosis, classification, prognosis, theranostics and therapeutic monitoring.  In the meantime, we are developing a preeclampsia diagnosis and prediction test, and are in active licensing effort for other pregnancy-related conditions.

Breast Cancer

IVD kits we offer include:

  • MammaTyper® Kit for breast cancer molecular subtyping (under exclusive partnership with BioNtech AG of Germany)
  • PD-L1 IHC Kit

Products in our development pipeline include:

  • RPS Gene Expression Signature  
  • FGFR1 Gene Amplification* Detection Kit for QPCR
  • FGFR1 Gene Amplification* Detection Kit for FISH
  • PIK3CA Mutation Analysis Kit for Real-Time PCR

Lung Cancer

IVD kits we offer include:

  • EGFR Mutation Analysis Kit for Real-Time PCR (29 mutations in exons 18, 19, 20 and 21)
  • KRAS  Mutation Analysis Kit for Real-Time PCR (codons 12 and 13)
  • BRAF Mutation Analysis Kit for Real-Time PCR (V600E)
  • EML4-ALK Fusion Mutation Analysis Kit for Real-Time PCR
  • PD-L1 IHC Kit

Products in our development pipeline include:

  • FGFR1 Gene Amplification* Detection Kit for QPCR
  • FGFR1 Gene Amplification* Detection Kit for FISH
  • RPS Gene Expression Signature  
  • PIK3CA Mutation Analysis Kit for Real-Time PCR
  • ROS1 Gene Rearrangement Detection Kit

*Shuwen has the exclusive patent right in certain major markets to the diagnostic test of FGFR1 gene amplification in certain tumor types.

Colorectal Cancer

IVD kits we offer include:

  • KRAS Mutation Analysis Kit for Real-Time PCR (codons 12 and 13)
  • BRAF Mutation Analysis Kit for Real-Time PCR (V600E)

Products in our development pipeline include:

  • Previstage GCC Colon Cancer Molecular Staging (Partnered with DiagnoCure Inc.)
  • PIK3CA Mutation Analysis Kit for Real-Time PCR
  • Microsatellite instability (MSI) Assay Kit
  • Proprietary biomarkers for colorectal cancer theranostics

Pregnancy-Related Conditions

Products in our development pipeline include:

  • A Urine-Based Screening Kit for Preeclampsia

Non-Oncology

Due to the centralized healthcare system and highly concentrated physicians in large hospitals in China, we see synergies between oncology and prenancy-related products and diagnostic products in other disease areas.  Hence, Shuwen is also developing or seeking to in-license products for various different disease areas, including:

  • Women’s health
  • Urology
  • Autoimmune diseases
  • Neurological diseases
  • Infectious Diseases
  • Others

Learn more about the benefits of partnering with Shuwen.