EpiDirect

Primary DI

5713915ED001LYBS

Basic UDI-DI Code

B-5713915ED001LYBS

Reference

8300:8302;8303

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

EpiDirect® MGMT Methylation qPCR Assay is a semi-automated real-time Polymerase Chain Reaction (PCR) assay intended for the direct, semi-quantitative analysis of the methylation status of the human gene of the DNA repair enzyme O6-methylguanine-DNA methyltransferase (MGMT). The assay is intended for purified genomic DNA (gDNA) samples that without further pre-treatment can be used with real-time PCR systems for the detection and quantification of the methylation status of the MGMT promoter. Samples comprise solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) material and can be prepared using automated platforms or in manual workflows. Methylation of MGMT is a prognostic and predictive marker in solid biopsies from glioblastoma patients. EpiDirect® MGMT Methylation qPCR Assay is intended to detect and provide the relative quantity of the amount of methylated versus unmethylated DNA in the MGMT promoter. The assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorisation.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).