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Official Collaboration | WuXi Diagnostics Partners with CST to Develop Diagnostic Assays

Recently, Shanghai WuXi Diagnostics Co.Ltd (WXDX) and Cell Signaling Technology (CST) announced a new partnership to collaborate on the development of targeted companion diagnostics (CDx). WXDX will use the world-class antibodies produced by CST in the development of new CDx assays. Working together, these two companies will facilitate the development of diagnostic tests that will help support innovative tumor diagnosis and treatment.

As a leading supplier of antibodies, kits, and services, CST is committed to providing high-quality research and diagnostic tools for the biomedical research community, with outstanding contributions that facilitate the progress of translational biology and precision medicine. WXDX has years of experience using evidence-based IHC research to develop diagnostics and has successfully ushered many medical test kits through development, clinical trials, and the registration process. Through collaborations with multiple pharmaceutical companies, WXDX has built a thorough standardization procedure for globally partnered laboratories to usher CDx assays through multiple stages to FDA registration. By collaborating with CST, a manufacturer of award-winning research antibodies, WXDX can further support the production, registration, and commercialization of companion diagnostics to meet growing global needs. The two companies will continue to dedicate resources toward developing diagnostic tools designed to accelerate biological understanding, furthering researchers' missions to find cures for human disease.

The collaboration between the two companies will begin by targeting human fibroblast growth factor 19 (FGF19), an important protein implicated in cancer progression, particularly for hepatocellular carcinoma (HCC). FGF19 has become an attractive target for cancer therapeutics as its signaling pathway has been shown to be active in many cancers, including those of the gallbladder, colon, lung, breast, ovaries, and head and neck squamous cell carcinomas. By utilizing a highly specific rabbit monoclonal antibody developed by CST in WXDX’s development of a new CDx assay, advancements in the detection and research of FGF19-based cancer pathology can be made.

Immunohistochemical analysis of paraffin-embedded human mucinous adenocarcinoma of the colon using FGF19 (D1N3R) Rabbit mAb.

To develop trusted and reliable medical CDx assays, it is crucial to start with the highest-quality antibodies, with assurance that these essential raw materials will be supplied on time, exactly when they are needed. The continuity of the global supply chain continues to be critical for translational research and development and the medical community.

“CST produces over 95% of our antibodies in-house, so we have exceptional control over our supply with the ability to ship our products immediately around the globe where and when they are needed,” said Roberto Polakiewicz, Chief Scientific Officer at CST. “By partnering with a global Contract Research, Development, and Manufacturing Organization like WXDX, CST can put our expertise in making highly specific and rigorously validated antibodies to good use and continue supporting the transformation of preclinical research into novel diagnostic solutions that may ultimately further our understanding of disease and impact the lives of patients.”

With a strategic plan in place, WXDX and CST will work together on specific projects to provide comprehensive solutions for oncology research and precision medicine

About WuXi Diagnostics

WuXi Diagnostics is one of the first companies in China to integrate and establish a corresponding open-access enabling platform. The company owns CAP and GCP certificates for clinical laboratories with all-discipline practicing qualifications in Shanghai, a global industrialization facility with ISO13485-certified in Suzhou, and an innovation project center in Rochester, US. Leveraging advanced knowledge and expertise in integrated diagnostics, based on all-discipline testing techniques and pathologies, WXDX has established an open-access enabling platform with multidisciplinary technologies, clinical data, and algorithms. The company has developed nearly 100 biomarker testing methods and served nearly 100 innovative pharmaceutical and biotech companies worldwide. So far, WXDX has obtained 1 Class III IHC certificate for companion diagnosis products, more than 20 Class II product certificates, and more than 140 Class I filing certificates for IHC products, these achievements are all competitive advantages in the industry.

WXDX has focused on the research and development of IHC companion diagnosis (CDx) products for years, accumulated extensive experience in CDx product development and registration, and provides end-to-end integrated solutions. The company has successfully carried out biological target development, test kit development, clinical trials, and registration application of multiple disease targets. The company offers a complete solution for IHC platforms, including primary antibodies, secondary antibodies, and an IHC automated stainer for antibody screening, protocol establishment, and CDx product development, depending on the needs of pharmaceutical companies. With its outstanding capacity to integrate medical and business resources, WXDX accelerates the development, registration, and commercialization of CDx products, supporting precise diagnosis and treatment for patients globally.

About Cell Signaling Technology

Cell Signaling Technology (CST) is a different kind of life science company—one founded, owned, and run by active research scientists, with the highest standards of product and service quality, technological innovation, and scientific rigor. Founded in 1999 and headquartered in Danvers, Massachusetts, USA, CST employs over 600 people worldwide. We consistently provide fellow scientists around the globe with best-in-class products and services to fuel their quests for discovery. CST is a company of caring people driven by a devotion to facilitating good science—a company committed to doing the right thing for our customers, our communities, and our planet.

CST Media and Press:

Rebecca J. Reppucci, MBA
Cell Signaling Technology, Inc.
Senior Director, Global MarComm & Technology
Phone: +1-978-880-3334
email: [email protected]