Chinese FDA Awards MammaTyper Innovative Product Status for Expedited Approval

Shuwen Biotech Co. Ltd. gets the Chinese FDA (CFDA) issuance of the "Innovative Medical Product" status for MammaTyper. The device is a real-time PCR kit for breast cancer stratification.

The device is a molecular diagnostic test for breast cancer stratification with Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue samples.

Since the fast-track program was initiated in March 2014, only ten in vitro diagnostics devices (IVD) have been granted access to the special approval process. — Cynthia Jessup