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

Trade name

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

UDI-DI code

06975970650033

Basic UDI-DI

B-06975970650033

Reference / catalog number

QP02004802

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

No certificate specifically references this device's Basic UDI-DI.