--- Query Results --- | |||||||||
| Organization: | Alberta Precision Laboratories | ||||||||
| Message Alert: | PLEASE NOTE: This Test Directory is in an interim state and due to changes pertaining to the DynaLIFE transition, performing site for routing has not been updated. Please refer to Laboratory Information System for appropriate routing. | ||||||||
| Test Name/Synonym: | Fusion RNA Panel, Tumor (Synonym: Pan-Solid Tumor Fusion Panel) | ||||||||
| Clinical Indications: | Diagnostic gene fusion detection in solid tumors. | ||||||||
| Test Includes: | Detection of fusions, oncogenic isoforms and/or selected single nucleotide variants (SNVs) and small insertions/deletions (indels) in the following 103 genes: AKT1, AKT3, ALK, AR, ARHGAP26, BCOR (including BCOR ITD), BRAF, BRD3, BRD4, CAMTA1, CCNB3, CIC, CSF1, CSF1R, CTNNB1, DNAJB1, EGF, EGFR, EPC1, ERBB2, ERBB4, ERG, ESR1, ETV1, ETV4, ETV5, ETV6, EWSR1, FGFR1, FGFR2, FGFR3, FOS, FOSB, FOXO1, FOXO4, FUS, GLI1, GLI2, GNAS, HMGA2, HRAS, IDH1, IDH2, JAZF1, KRAS, MAML2, MAP2K1, MEAF6, MET, MKL2, MN1, MSANTD3, MYB, MYBL1, MYOD1, NCOA1, NCOA2, NOTCH1, NOTCH2, NOTCH3, NR4A3, NRAS, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, PAX3, PDGFB, PDGFRA, PDGFRB, PHF1, PLAG1, PPARG, PRDM10, PRKACA, PRKCA, PRKCB, PRKCD, PRKD1, PRKD2, PRKD3, RAF1, RELA, RET, ROS1, SRF, SS18, SS18L1, STAT6, TAF15, TCF12, TERT, TFCP2, TFE3, TFEB, THADA, THBS1, TMPRSS2, USP6, VGLL2, YAP1, YWHAE. Note that while selected SNVs/indels can be detected on this panel, RNA is not an ideal analyte for detecting these mutations, and this test cannot exclude SNVs/indels when not detected. The panel is primarily indicated for detection of fusions and oncogenic isoforms. | ||||||||
| Ordering Alert: | Test ordering restricted to pathologists. | ||||||||
| Collection Alert: | Please provide a brief summary of the pathologic context +/- suspected fusion on the requisition, and a copy of the corresponding pathology report if available. | ||||||||
| Test Code: |
| ||||||||
| Specimen Type: | Formalin Fixed Paraffin-Embedded tissue (FFPE) only | ||||||||
| Specimen Source: | Indicate specimen source. | ||||||||
| Primary Container: | See Specimen Collection Requirements | ||||||||
| Specimen Collection Requirements: | A formalin-fixed, paraffin-embedded tissue block (resection specimen, biopsy specimen, cell block) accompanied by a representative H&E (ideally the deepest level) is preferred. The assay requires a minimum of 20% tumor in the selected area (20 tumor nuclei per 100 total nuclei). When possible, non-Cytolyt®-exposed FFPE tissue is preferred over Cytolyt®-exposed FFPE tissue (cytology cell blocks).
Alternatively, five 10-micron non-baked unstained slides accompanied by a representative H&E (ideally the deepest level) can be submitted. If the sample is relatively small (less than 10mm squared, for example a core biopsy 1mm in diameter and less than 1cm in length), particularly if the tissue has a low cell density, more than 5 (up to 10) 10-micron non-baked unstained slides may be sent to increase RNA yield for testing. Alternatively, precut scrolls can be submitted, accompanied by a representative H&E (ideally cut after the scrolls). Note: The tissue should not be exposed to decalcification solution. | ||||||||
| Test Resources: | Submit request using the applicable requisition or Connect Care online order entry. In the North sector, requests should be submitted on the Molecular Pathology North requisition. In the South sector, requests should be submitted on the Molecular Pathology South requisition.
Please ensure all required information, including patient's clinical history/indication, is provided on the requisition. | ||||||||
| Stability and Storage: | Room temperature: paraffin-embedded tissue blocks and slides | ||||||||
| Transportation: |
| ||||||||
| Method: | Next-generation sequencing | ||||||||
| Method and Interpretation of Results: | RNA is analyzed using next generation sequencing (NGS) to detect gene fusions, oncogenic isoforms, and selected single nucleotide variants (SNVs) and insertions / deletions (indels). The assay utilizes a custom 103 gene Archer FusionPlex® panel, which uses anchored multiplex PCR (AMP) to enable partner-agnostic fusion detection. NGS libraries are sequenced on the Ion Torrent Genexus™ System and analyzed on Archer® Analysis with alignment to reference human genome GRCh37/hg19. The analysis is limited to tumor tissue and, therefore, this test is unable to distinguish between somatic (acquired) and germline (inherited) variants. | ||||||||
| Routine Turn Around Time: | 10 days | ||||||||
| Testing Schedule: | Weekly | ||||||||
| Testing Area: | Molecular Pathology | ||||||||
| Performing Site: | Foothills Medical Center | ||||||||
| Contact Comments: |
| ||||||||
| Last Updated On: | Friday, April 8, 2022 | ||||||||
| Registered Trademark Comments: | CYTOLYT® is a trademark of Hologic, Inc. FusionPlex® and Archer ® Analysis are registered trademarks of ARCHERDX, LLC Genexus™ is a trademark of Life Technologies Corporation | ||||||||
