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BioNTech, Shuwen Ink Chinese Distribution Deal for Breast Cancer Stratification Test

NEW YORK (GenomeWeb) – Germany's BioNTech Diagnostics and Shuwen Biotech said today that they have signed a deal to commercialize BioNTech's molecular breast cancer stratification test MammaTyper in China.

According to BioNTech, MammaTyper is a CE-IVD marked test that measures expression levels of four genes in breast cancer tissue via RT-qPCR in order to stratify tumor samples into four subtypes: luminal A-like, luminal B-like/HER2 negative, luminal B-like/HER2 positive, HER2 positive/non-luminal, and triple-negative/ductal.

Under the terms of the agreement, Deqing, China-based Shuwen will undertake clinical studies to obtain regulatory approval of MammaTyper in China, where it will be the test's exclusive distributor. Financial and other terms were not disclosed.

"This is a strategic long-term cooperation to establish and strengthen our position in the Chinese oncology diagnostics market and will pave the way for launching our own personalized immunotherapies for the treatment of cancer in China," Sierk Poetting, BioNTech CFO and managing director of BioNTech Diagnostics, said in a statement.

BioNTech Diagnostics is a wholly owned subsidiary of BioNTech, a privately owned cancer drug developer that was founded in 2008.