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Oncgnostics Cervical Cancer Assay Receives Extended CE-IVD Mark


NEW YORK (GenomeWeb) – Oncgnostics announced recently that it has received an extended CE-IVD mark for the GynTect cervical cancer assay. As a result, researchers can run the assay on Roche Diagnostics' Cobas z 480 quantitative PCR-based analyzer.

According to Jena, Germany-based Oncgnostics, the assay allows researchers to detect modified and methylated DNA regions, which specifically occur in cervical cancer. It noted that the GynTect assay requires a two-step process, chemical treatment with bisulphite to fixate the DNA methylation of the diagnostic material, followed by PCR to detect marker regions. During the PCR step, only methylated DNA regions in the sample are amplified.

Oncgnostics CEO and cofounder Alfred Hansel said that before the extension of its CE-IVD mark, GynTect could be run only with Life Technologies' ABI 7500 Real-Time PCR system. "With [Cobas z 480's] widespread availability, many more laboratories now can perform GynTect without any additional expenses," he said in a statement.