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Taiwan's iStat Biomedical Gets CE Mark for HPV-Associated Cancer Products

NEW YORK (GenomeWeb) – Taiwanese molecular diagnostics firm iStat Biomedical announced it has received five CE marks for products used in testing for human papillomavirus (HPV) and its associated cancers.

The products are iStat's Pax1 DNA Detection Kit, ZNF582 DNA Detection Kit, EpiGene HPV-M SpeedGel Kit, EpiGene DNA Extraction Kit, and Epigene Bisulfite Conversion Kit.

The Pax1 and ZNF582 kits are gene methylation detection assays for early-stage cervical and oral cancer screening, offering non-invasive swab-based collection methods, the firm said in a statement. Pax1 and ZNF582 methylation are potential biomarkers for cervical and oral cancers, respectively.

The EpiGene kits are important for sample preparation while the HPV-M SpeedGel Kit is a PCR-based test for HPV from patient samples.

The firm said it is finalizing regulatory clearance in the EU and plans to launch its products there in the fourth quarter of 2016.