Biocartis Idylla BRAF Mutation Test

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Disponível em:

ANDAMAN MEDICAL PTE. LTD.

Classe:

Class C IVD

Fabricado por:

Biocartis NV

Área terapêutica:

Pathology

Indicações terapêuticas:

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.

Resumo do produto:

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

Data de autorização:

2017-07-05