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Cerca Biotech Nabs CE Mark for Nucleic Acid Extraction Kit

NEW YORK – Oncology and women's health firm Cerca Biotech said Monday that it has secured CE marking for a kit used for RNA extraction from formalin-fixed paraffin-embedded tissue.

The Berlin-based firm said its RNXtract kit uses magnetic beads for RNA extraction and is intended for use in multiple applications including the firm's real-time qPCR MammaTyper kit for breast cancer classification.

Cerca Biotech announced two years ago it reached a deal to acquire MammaTyper and related assets from BioNTech Diagnostics. The assay is used to quantify mRNA levels of the breast cancer biomarkers ER, PgR, HER2, and Ki-67 in surgical or biopsy tissue samples and stratify patients by St. Gallen subtype.

Cerca also inked a deal this spring for Sysmex Europe to distribute the MammaTyper assay in 13 European markets.

"We are happy to offer to our customers this new tool for molecular diagnosis using FFPE tissue samples," Cerca Commercial Director Rich Hughes said in a statement. "We strive to offer better solutions in oncology and women's health through our innovative diagnostic products such as MammaTyper and RNXtract."