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FusionPlex Solid Tumor Panel
Clinical Genetic Test
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offered by
Clinical Genomics Laboratory
View lab's test page
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GTR Test Accession: Help GTR000588101.4
CANCERRESPIRATORY DISEASE
Last updated in GTR: 2022-05-25
View version history
Last annual review date for the lab: 2024-06-24 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Conditions (3): Help
Solid tumor; Lung carcinoma; Sarcoma
Genes (114): Help
ABL1 (9q34.12); ABL2 (1q25.2); AKT1 (14q32.33); AKT2 (19q13.2); AKT3 (1q43-44) more...
Methods (1): Help
Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with solid tumors (e.g. sarcomas, lung cancers, thyroid cancers, …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Clinical Genomics Laboratory
View lab's website
View lab's test page
Test short name: Help
FusionPlex ST
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Yu Wu, PhD, Lab Supervisor
yw76@uw.edu
206-616-4062
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
Test kits with return shipping are available, as needed. Email whitneyn@uw.edu or call 206-598-8684 to request kits. Please see the lab's website for complete information about sample requirements, ordering and shipping, and test requisitions.
Order URL
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
No
Test strategy: Help
Ordering providers can also request FusionPlex Solid Tumor testing for a single gene (CPT 81479) or for a small subset (2-10 genes) of genes on the panel (CPT 81479).
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Test Order Code
Conditions Help
Total conditions: 3
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 114
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina NextSeq
Clinical Information
Test purpose: Help
Diagnosis; Prognostic; Therapeutic management
Target population: Help
Patients with solid tumors (e.g. sarcomas, lung cancers, thyroid cancers, head and neck cancers, renal cell carcinomas, mammary gland tumors, prostate cancers, brain tumors)
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
No.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
No. .
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
Total nucleic acid (TNA) is extracted from the sample using standard procedures. First- and second-strand complementary DNA (cDNA) synthesis is performed. A library of DNA fragments is constructed for targeted capture of cDNA from fusion genes using Archer® custom designed FusionPlex® BBI Solid Tumor panel and reagent kit (ArcherDX, Boulder, … View more
Test Platform:
Affymetrix GeneChip Human Genome U133 Plus 2.0 Array
Test Comments: Help
Ordering providers can also request FusionPlex Solid Tumor testing for a single gene (CPT 81479) or for a small subset (2-10 genes) of genes on the panel (CPT 81479).
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Validation cohort included 22 known negative cases and 102 known positive cases. Two initially discordant cases with negative FusionPlex results turned out to be false positive FISH results after subsequent FISH reexamination. After this adjustment, the analytic specificity and sensitivity were both 100%.
Assay limitations: Help
The FusionPlex Solid Tumor Panel is used in this test for the sole purpose of identifying gene fusions with both known and unknown fusion partners of solid tumor-associated gene targets. This assay does not detect gene fusions located outside the targeted gene regions. This test is also has limited ability … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
VUS:
Software used to interpret novel variations Help
Quiver(R) Fusion Database
Recommended fields not provided:
Test Confirmation, Citations to support assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.