NEW YORK (GenomeWeb) – Germany-based BioNTech Diagnostics and Shuwen Biotech, its partner in China, announced that their MammaTyper real-time PCR breast cancer stratification kit has been granted an expedited review for regulatory approval by the China Food and Drug Administration (CFDA).
The agency will review the diagnostic under a special process designed to expedite the approval of innovative products, the companies said.
MammaTyper, which is also CE-IVD marked for use in Europe, is a molecular diagnostic test for breast cancer stratification with formalin-fixed paraffin-embedded tumor tissue samples. The test measures four genes in breast cancer tissue via real-time 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. The goal is to improve the accuracy of diagnosis and inform treatment decisions, BioNTech said.
"We are very pleased that the CFDA has recognized the innovative and significant clinical value of MammaTyper," said Shuwen Chairman and CEO Jay Zhang in a statement. "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 and Shuwen signed a deal to commercialize MammaTyper in China in early December 2015. Later that month, the company told GenomeWeb that it was looking to globally commercialize the diagnostic, and was looking for a US partner to usher the test through US Food and Drug Administration approval.