BUSINESS

Guanz Diagnostic Laboratories

The third-party independent laboratory of Shuwen Biotech can provide high-quality clinical trial sample testing services for domestic/international innovative pharmaceutical enterprises,and also provide high-level third-party independent medical testing services for the majority of medical institutions,doctors and patients.

Along with a wealth of R&D and registration experience in the field of IVD,as well as being a long-standing LDT service provider for numerous pharmaceutical companies,Shuwen Guanz is fully capable of providing one-step services in companion diagnosis R&D for pharmaceutical companies.

Founded on the principles of innovation,patent protection,and international collaboration,Shuwen established strategic partnerships with leading academic and commercial institutions to commercialize first-in-class diagnostic technologies and patents,and has developed a range of novel diagnostics in the fields of cancer and women's health. Shuwen has also developed quality companion diagnostics and provided central lab biomarker testing services to leading pharmaceutical developers and hospitals. Shuwen houses an in-house development team,CAP-accredited central labs,and GMP/ISO13485-certified IVD manufacturing facilities, all in line with global standards to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health. Innovative products are offered on the international market through Cerca Biotech GmbH,Shuwen's European subsidiary in Berlin.

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Cancer Testing Services

BREAST CANCER

  • maxBRCA™
  • maxHBOC™
  • MammaTyper®
  • EndoPredict®
  • HER2 gene amplification test
  • PD - L1 expression level detection
  • RDS® tumor DNA recombination repair defect score
  • 32-gene panel for treatment guidance in HR+ breast cancer
  • 56-gene panel for genetic breast cancer testing
  • 103-gene panel for personalized treatment in HR+ breast cancer
  • 164-gene panel for personalized treatment in HR- breast cancer
  • 205-gene panel for comprehensive breast cancer testing

Other Cancers

  • Non-small cell lung cancer NGS panel
  • Colorectal cancer NGS panel
  • Gastric/esophageal cancer NGS panel
  • Gastrointestinal stromal tumors NGS panel
  • Hepatobiliary tumor NGS panel
  • Pancreatic cancer NGS panel
  • Prostate cancer NGS panel
  • ......

PAN-CANCER TESTING

  • Pan-cancer 105-gene panel
  • Pan-cancer 105-gene plus panel
  • Pan-cancer 201-gene panel
  • Pan-cancer 201-gene plus panel
  • Pan-cancer 680-gene panel
  • Microsatellite instability (MSI) detection
  • HER2 gene amplification test
  • Mismatch repair (MMR) protein test
  • PD-L1 expression level detection
  • 30-gene detection for chemotherapy resistance
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Pharm Services

We have developed IVD kits for biotech/pharmaceutical companies as companion/complementary diagnostics in their clinical trials for new drug development. Assays and kits have been developed in various different technology platforms including immunohistochemistry (IHC),PCR,RT-qPCR,capillary electrophoresis,and next generation sequencing (NGS), among others.

In our CAP-accredited central labs, we have completed testing of tens of thousands patient samples from clinical trials of our pharm clients, effectively facilitating innovative drug development.

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