Idylla GeneFusion Assay (RUO)
A0121/6
The fully automated Idylla™ GeneFusion Assay detects ALK, ROS1, RET, NTRK1/2/3 rearrangements & MET Exon 14 skipping in a single cartridge.
*For samples with 10% neoplastic cell content, 3 slices if tissue area < 20 mm2
DETECTION OF KNOWN AND NOVEL FUSIONS
The new Idylla™ GeneFusion Assay is a unique combination of 2 detection technologies:
- Direct Detection: Highly sensitive detection of known fusion 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.
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
Idylla™ GeneFusion Assay is for Research Use Only, not for use in diagnostic procedures
Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc. This product 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, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation.
