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Biocartis Idylla BRAF Mutation test pack (6 tests/pack), CE-IVD

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SKU A0120/6

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For professional/laboratory use only.

Intended Use
The Biocartis Idylla™ GeneFusion Panel is a fully automated in vitro diagnostic test intended for the qualitative detection of specific gene fusions of ALK, ROS1, RET as well as MET exon 14 skipping. The Idylla™ GeneFusion Panel is intended for use with formalin-fixed, paraffinembedded (FFPE) tumor tissue sections from patients with non-small cell lung cancer (NSCLC). The Idylla™ GeneFusion Panel covers the entire process from sample to result, including fully
integrated RNA and DNA extraction, reverse transcription of mRNA, real-time PCR amplification and detection, data analysis, and result reporting.

Indications for Use
The Idylla™ GeneFusion Panel is for use by healthcare professionals for identifying the panel gene rearrangements for patients with NSCLC, to predict the most appropriate treatment options. The Idylla™ GeneFusion Panel is not intended to diagnose NSCLC.

Documents

Idylla_GeneFusion-Panel_IVD_Tech-Sheet.pdf

Technical Sheet

EN | 134.54 KB

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Idylla_GeneFusion-Panel_IVD_Leaflet.pdf

Idylla Specimen Requirements Sheet

EN | 972.286 KB

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Idylla-Brochure.pdf

EN | 3.128 MB

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