Idylla GeneFusion Panel (CE-IVD)
A0120/6
Within 180 minutes and with less than 3 minutes hands-on time, the fully automated Idylla™ GeneFusion Panel detects ALK, ROS1 and RET fusions & MET exon 14 skipping in a single cartridge using only 1-3* FFPE tissue sections from patients with NSCLC.
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*Check specimen requirements in section below
The Idylla™ GeneFusion Panel contains SuperScript™ III Reverse Transcriptase and is provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation. Patens under license from Cell Signaling Technology. For more information, click here.
DETECTION OF KNOWN AND NOVEL FUSIONS
The new Idylla™ GeneFusion Panel is a unique combination of 2 detection technologies:
- Gene fusion specific and METex14 skipping detection: Highly sensitive detection of known skipping isoforms by RT-qPCR of sample RNA.
- 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. Expression imbalance results are indicative for the presence of a fusion or other rearrangements that lead to kinase domain expression and should be confirmed with another technology.
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 (in 90% of all cases)
- If < 20 mm² tissue area -> 3 x 5 μm FFPE tissue sections
- ≥ 10% neoplastic cell content
