COMPANY:

Shuwen Biotech

"Cerca Biotech GmbH announces that in the 14th European Breast Cancer Conference (EBCC-14) in Milan, Italy from March 20 to 22, results from five different studies on MammaTyper® were presented by leading experts and researchers."

"A seminal study presented at the San Antonio Breast Cancer Symposium (SABCS) this week has shown that the validated, locally performed, RNA-based MammaTyper® test provides progesterone receptor (PGR) expression determination that could predict low recurrence risk score under OncoType DX and independently identify breast tumours that are unlikely to be chemotherapy sensitive. This could obviate further testing with the multigene signature prognostic assay for up to 70% of patients."

"Cerca Biotech...announced that its quality management system (QMS) has achieved ISO 13485:2016 certification for the design and development, production and distribution of in vitro diagnostics and software for molecular testing."

"Sysmex Europe and Cerca Biotech said...that they have inked a deal for Sysmex to distribute Cerca's molecular breast cancer assay in 13 European markets...German diagnostic firm Cerca's RT-qPCR MammaTyper assay is used to identify breast cancer subtypes through quantitative measurement of mRNA expression status for four genes in breast cancer tissue."

"...Shuwen Biotech...announced that it has acquired from Fudan University Shanghai Cancer Center (FUSCC) patents covering the 'Fudan Subtyping,' a breakthrough in molecular subtyping of triple-negative breast cancer (TNBC) that significantly improves treatment outcome of TNBC. Shuwen has also formed research collaboration with the Center to develop and commercialize the technology."

"Three new research studies have concluded that MammaTyper could provide a reliable, efficient, and reproducible alternative to the molecular subtyping of breast cancer tumours...Studies in the UK, Portugal and China involving over 350 samples suggest that MammaTyper, a multigene rapid PCR test to subtype breast cancer tumours could be a viable alternative to IHC testing, which is the current method used by most healthcare systems and labs around the world."

"Shuwen Biotech...announces that it has obtained a CE mark for its quantitative qPCR kit for measuring ERBB2 gene expression in breast cancer tissue (CercaTestTM ERBB2 Assay)...CercaTestTM ERBB2 Assay is a quantitative real-time PCR assay for accurate measurement of ERBB2 gene expression in breast cancer tissue slices. Contiguous quantitative PCR cycle numbers may be generated from different FFPE tissue samples with the same IHC scores (such as HER2 0 or 1+), allowing delineation of different ERBB2 mRNA expression levels in full spectrum."

"Shuwen Biotech...today announces that it has entered into a distribution agreement with Devyser Diagnostics...to market and support Devyser BRCA NGS and other oncology kits in China. Under the terms of the agreement, Shuwen will distribute the Devyser kits in China and also offer testing and NGS data analysis services with the Devyser kits in its CAP-accredited clinical labs in China."

"German diagnostics firm Cerca Biotech said on Wednesday that it has signed four distribution agreements covering key European markets for its MammaTyper breast cancer subtyping assay...According to Cerca, it has struck distribution deals with Italy's AB Analytica, Turkey-based Omegen Molecular, Romania's Diamedix, and Buhlmann Labs in Switzerland to distribute the test throughout much of Southern and Central Europe."

"Cerca Biotech GmbH...announced an asset purchase agreement with BioNTech Diagnostics AG...relating to MammaTyper®, a molecular diagnostics for breast cancer subtyping. Under the agreement, Cerca will acquire from BioNTech its rights and interest in MammaTyper® and the associated nucleic acid extraction kit RNXtract®. Cerca will be responsible for the development and commercialization of the products worldwide."