BioNTech Diagnostics GmbH, a fully owned subsidiary of BioNTech AG, and its Chinese partner Shuwen Biotech Co. Ltd. announced that the Chinese FDA (CFDA) has granted the "Innovative Medical Product" status for MammaTyper, a real-time PCR kit for breast cancer stratification. This diagnostic product will undergo a special process designed by the CFDA to expedite the regulatory approval of innovative products.
MammaTyper met the highly stringent criteria set by the CFDA for products entering the fast-track procedure. Since the program was initiated in March 2014, only ten in vitro diagnostics devices (IVD) have been granted access to the special approval process.
"We are very pleased that the CFDA has recognized the innovative and significant clinical value of MammaTyper," stated Jay Z. Zhang, chairman and CEO of Shuwen Biotech. "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."
Dr Sierk Poetting, CFO of BioNTech AG and managing director of BioNTech Diagnostics, commented: "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."
The CE-IVD marked MammaTyper test is a molecular diagnostic test for breast cancer stratification with FFPE tumor tissue samples. Based on precise measurements of gene expression by RNA analysis, MammaTyper has the potential to significantly improve the standard of diagnosis and ultimately treatment of breast cancer patients.
Based in China and led by US diagnostic industry veterans, Shuwen Biotech is an integrated diagnostic company engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine.
BioNTech AG is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases.