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BioNTech, Shuwen get CFDA innovative medical product status for MammaTyper test

MDBR Staff Writer Published 22 August 2016

BioNTech Diagnostics and Shuwen Biotech have secured innovative medical product status from the China Food and Drug Administration (CFDA) for the MammaTyper PCR kit for breast cancer stratification.

MammaTyper test is a molecular diagnostic test developed for breast cancer stratification with FFPE tumor tissue samples.

With the help of precise measurements of gene expression by RNA analysis, the CE-IVD marked test will enable physicians to treat breast cancer patients effectively.

According to BioNTech, the diagnostic product will undergo CFDA special process to expedite the regulatory approval of innovative products.

MammaType met CFDA criteria to enter the fast-track procedure.

Only ten in vitro diagnostics devices (IVD) were granted access to the special approval process, since the program was initiated in March 2014.

Shuwen Biotech chairman and CEO Jay Zhang said: "We will work closely with the CFDA towards an expedited approval to allow Chinese breast cancer patients to have full access to the clinical benefit of MammaTyper." 

BioNTech Diagnostics managing director Dr Sierk Poetting said: "This is a major milestone for MammaTyper® and we are very pleased with the CFDA's recognition.

“We congratulate our colleagues at Shuwen for their accomplishment in obtaining the special approval process from the CFDA for MammaTyper. We look forward to expanding the access to MammaTyper® to one of the largest populations in the world." 


Image: MammaTyper PCR kit for breast cancer stratification. Photo: courtesy of BioNTech AG.