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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: | Kinase Fusion RNA Panel, Tumor (Synonyms: NTRK, ALK, ROS1, RET, FGFR2) | ||||||||
Clinical Indications: | Diagnostic and/or predictive biomarker testing for kinase gene fusions in solid tumors.
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Test Includes: | RNA testing (Lung Carcinoma Fusion RNA Panel) covers fusions, oncogenic isoforms and/or selected single nucleotide variants (SNVs) and small insertions/deletions (indels) involving the following 17 genes: ALK, BRAF, EGFR, ERBB2, FGFR1, FGFR2, FGFR3, KRAS, MET, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, PIK3CA, RET, ROS1. 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. | ||||||||
LABID (Connect Care): | LAB8031 | ||||||||
Specimen Type: | Paraffin-Embedded Tissue | ||||||||
Specimen Source: | Various | ||||||||
Primary Container: | See Specimen Collection Requirements | ||||||||
Specimen Collection Requirements: | A formalin-fixed, paraffin-embedded tissue block (resection specimen, biopsy specimen, cytology cell block) accompanied by a representative H&E (ideally the deepest level) is preferred. The assay requires a minimum of 5% tumor in the selected area (5 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 nucleic acid 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:
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: | Transport at room temperature. | ||||||||
Method: | Molecular Pathology South RNA Next Generation Sequencing (NGS) | ||||||||
Method and Interpretation of Results: | RNA: Analysis is performed 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 17 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. 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 working days. | ||||||||
Testing Schedule: | Weekly | ||||||||
Testing Area: | Molecular Pathology | ||||||||
Performing Site: | Foothills Medical Center | ||||||||
Contact Comments: |
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Last Updated On: | Monday, July 24, 2023 |