Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)

Primary DI

06972665700295

Basic UDI-DI Code

B-06972665700295

Reference

Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

XIAMEN SPACEGEN CO.,LTD.

16 Tests/kit,Lynch syndrome is a highly penetrant, autosomal dominant genetic predisposition syndrome. It is caused by monoallelic germline mutations in mismatch repair genes, particularly MLH1, MSH2, MSH6 or PMS2, or by germline deletions in EPCAM resulting in epigenetic silencing of the adjacent MSH2 gene. NCCN guidelines recommend that all patients with newly diagnosed colorectal cancer should be initially screened by immunohistochemistry or microsatellite instability detection of four MMR proteins (MSH2, MSH6, PMS2, MLH1) in tumor tissue. For patients with dMMR identified by immunohistochemical testing, further testing for germline mutations in genes with loss of protein expression is recommended. For patients with dMMR identified by MSI, germline mutation testing of five genes, MSH2, MSH6, PMS2, MLH1, and EPCAM, is recommended.

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