Biocartis Idylla BRAF Mutation Test

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

可用日期:

ANDAMAN MEDICAL PTE. LTD.

类:

Class C IVD

厂商:

Biocartis NV

治疗领域:

Pathology

疗效迹象:

The Idylla™ BRAF Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic Test for the qualitative detection of V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene. The Idylla™ BRAF Mutation Test uses DNA liberated from formalin-fixed paraffin-embedded (FFPE) tissue sections from human melanoma tumor cells. The Test is a sample-to-result real-time PCR. The results of the Idylla™ BRAF Mutation Test may be useful for the physician to aid in identifying metastatic melanoma patients who may benefit from BRAF targeted therapy. The Idylla™ BRAF Mutation Test is not intended to diagnose metastatic melanoma. The physician shall take other disease factors into account, other than the patient’s mutation status, to make a therapy decision.

產品總結:

Models: Idylla Instrument - P0010, Idylla Console - P1010, Idylla BRAF Mutation Test - A0010/6

授权日期:

2017-07-05