QIAGEN (Suzhou) and Abcam sign strategic MoU collaboration agreement to co-develop companion diagnostic (CDx) and in vitro diagnostic (IVD) reagents and kits for the Chinese market

Suzhou, China and Cambridge, UK, December 6: Abcam plc, a global innovator in life science reagents and tools, and QIAGEN (Suzhou) Translational Medicine Co., Ltd. (QIAGEN (Suzhou)) have signed a Memorandum of Understanding (MoU) agreement to jointly develop a pipeline of Companion Diagnostic (CDx) and In Vitro Diagnostic reagents and kits, to meet the specific needs of the Chinese market.

Under the terms of this agreement, the teams will work closely together to develop kits targeting pan-NTRK, dMMR, as well as other protein-based CDx products. Previously, the organisations have successfully collaborated on the development of immunohistochemical (IHC) assay kits for dMMR (MSH2, MSH6, PMS2, and MLH1) which achieve high sensitivity and specificity. The components of the CDx kits developed for MSH2, MSH6, PMS2, and MLH1 antibody reagents have been filed as Class I medical devices by QIAGEN (Suzhou).

The organisations are targeting the rapidly increasing demand for protein CDx products within the Chinese market. The two sides have agreed to a long-term strategic collaboration that will see them working closely together in a mutually beneficial relationship that is aiming to support the increased growth of the companion diagnostic industry within China.

The industry has seen a rapid development in personalized medicine and precision medicine, where companion diagnostics plays a vital role. A companion diagnostic is used to assess drug treatment responses in patients and is helpful in determining the patients who are most likely to benefit from a particular treatment. The use of companion diagnostics helps improve overall drug efficacy and supports reduction in overall healthcare costs.

In 2014, the FDA (Food and Drug Administration, USA) released Guidance for Industry: In Vitro Companion Diagnostics Devices, which identifies the need for companion diagnostics at an earlier stage in the drug development process and to plan for co-development of the drug and companion diagnostic test.

About Abcam

As an innovator in reagents and tools, Abcam’s purpose is to serve life science researchers globally to achieve their mission, faster. Providing the research and clinical communities with tools and scientific support, the Company offers highly validated biological binders and assays to address important targets in critical biological pathways.

Already a pioneer in data sharing and ecommerce in the life sciences, Abcam’s ambition is to be the most influential company in life sciences by helping advance global understanding of biology and causes of disease, which, in turn, will drive new treatments and improved health.

Two-thirds of the world’s 750,000 life science researchers use Abcam’s affinity binders, reagents, biomarkers and assays and the Company’s products are mentioned in over 20,000 of the 56,000 peer-reviewed papers published each year in the life sciences.

By actively listening to and collaborating with researchers, the Company continuously advances its portfolio to address their needs. A transparent programme of customer reviews and datasheets, combined with an industry-leading validation initiative, gives researchers increased confidence in their results.

Abcam’s eleven offices are located in the world’s leading life science research hubs, enabling local services and multi-language support. Founded in 1998 and headquartered in Cambridge, UK, the Company sells to more than 100 countries. Abcam was admitted to AIM in 2005 (AIM: ABC).

About QIAGEN

As the leader of the entire solutions for companion diagnostics in the precision medical treatment in China, QIAGEN (Suzhou) is an innovative enterprise with a high starting point focusing on biomarkers, companion diagnostics, and their clinical application. With integrated translational medicine and product development platforms, and a strong technical team, QIAGEN (Suzhou) provides its partners with one-stop services from validation of biomarkers and development of test methods, to the molecular detection in patients with new drug clinical trials and screening patients for group enrolment, and the development and commercialization of companion diagnostic kits. Based on the comprehensive and integrated service technology platforms and the R&D of the companion diagnostic products, QIAGEN (Suzhou) has made remarkable achievements in the joint development of companion diagnostic products in the field of translational oncology and cancer immunotherapy based on nucleic acid and protein markers with pharmaceutical companies and offered integrated solutions to more than 70 pharmaceutical companies.