iStat Biomedical Co., Ltd. has announced that it has successfully gained CE approval of five IVD (DNA Methylation and related) products from the European Authority: (1) PAX1 DNA Detection Kit (2) ZNF582 DNA Detection Kit (3)EpiGene HPV-M SpeedGel Kit (4)EpiGene DNA Extraction Kitand (5)EpiGene Bisulfite Conversion Kit. “This is a major milestone for iStat Biomedical, and we are excited to introduce our products into the European biomedical community and benefit current diagnostic unmet needs” stated by Mr. W. T. Chen, Vice Chairman of iStat Biomedical Co., Ltd.
“Our DNA Methylation detection products offer clinicians an alternative choice for cancer diagnosis and treatment follow-up. These products concordance with the gold-standard cytological evaluations or HPV typing, are expected to reduce some of the interventional procedures unnecessarily performed and alleviate anxiety due to diagnostic uncertainties”. PAX1 DNA Detection Kit and ZNF582 DNA Detection Kit are company’s two major Methylation assay products in early detection of cervical and oral cancers.
Using swab samples through non-invasive collection procedures, PAX1 DNA detection kit provides clinicians with an alternative tool to diagnose cervical cancers in the early stage by analyzing biomarker “PAX1.” The ZNF582 DNA detection kit facilitates early detection and prognosis evaluation of oral cancer by analyzing biomarker “ZNF582.” EpiGene DNA Extraction Kit and EpiGene Bisulfite Conversion Kit are company’s two important auxiliary products for sample preparation prior to gene methylation assays.
EpiGene DNA Extraction Kit is intended for extracting total DNA from cervical and oral swabs. Whereas, EpiGene Bisulfite Conversion Kit converts unmethylated cytosines to uracils, while 5-methylcytosines remain unchanged. HPV-M SpeedGel Kit is a test for target amplification of sixteen human papillomaviruses (HPV) in patient’s specimens, utilizing the Polymerase Chain Reaction (PCR) and Agarose Gel Electrophoresis technologies. The company will proceed with final regulatory clearance and plan for initial commercial launch in EU in the fourth quarter of 2016.