Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing)

Dénomination commerciale

Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing)

Code d'IUD-ID

06975970650033

IUD-ID de base

B-06975970650033

Numéro de référence/catalogue

QP02004802

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

This kit is intended for the in vitro qualitative detection of DAB2IP, CHFR, and GRASP gene methylation in human plasma samples. It is suitable for assisting in the diagnosis of suspected hepatocellular carcinoma (HCC). The results cannot be used as the sole basis for the diagnosis or exclusion of tumors. DAB2IP encodes a Ras GTPase-activating protein (GAP) with tumor suppressor functions. Methylation of DAB2IP has been confirmed to be associated with the development and prognosis of HCC1 . The CHFR gene encodes an E3 ubiquitin-protein ligase, which is crucial for maintaining the regulation of the cell cycle checkpoint before mitosis. It plays a key role in the cell cycle process and tumorigenesis. Studies have found that the CHFR gene is highly methylated in HCC tissues and is associated with its prognosis 2 . The GRASP gene encodes a protein with molecular scaffold functions that connects receptors (including group 1 metabotropic glutamate receptors) with neuronal proteins. GRASP gene methylation is elevated in HCC tissues, and overexpression of GRASP can inhibit the proliferation and invasiveness of liver cancer cells3.

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.