Biocartis Idylla™ GeneFusion Assay*

Products are for professional/laboratory use only.

Within 180 minutes and with less than 2 minutes hands-on time, the fully automated Idylla™ GeneFusion cartridge detects ALK, ROS1, RET, NTRK1/2/3 rearrangements and MET exon 14 skipping in a single cartridge using only 1-3* FFPE tissue sections.

DETECTION OF KNOWN AND NOVEL FUSIONS

The new Idylla™ GeneFusion Assay is a unique combination of 2 detection technologies:

1. Direct Detection: Highly sensitive detection of known fusion isoforms by RT-qPCR of sample RNA.
2. Expression Imbalance Analysis: Detection of fusion events without knowledge of the fusion partners by analyzing expression ratios between the 5’ and 3’ ends of the gene.

SPECIMEN REQUIREMENTS

One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. With the Idylla™ system only a minimal amount of sample is needed:

• If ≥ 20 mm² tissue area -> 1 x 5 μm FFPE tissue section
• If < 20 mm² tissue area -> 3 x 5 μm FFPE tissue sections
• ≥ 10% neoplastic cell content

*Research use only

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