Classic view of this page
GTC-Solid Tumor Profile Plus Fusion/Expression (DNA and RNA)
Clinical Genetic Test
Help
offered by
Genomic Testing Cooperative, LCA
View lab's test page
LinkOut
GTR Test Accession: Help GTR000591834.1
CAP
Registered in GTR: 2020-09-08
View version history
Last annual review date for the lab: 2024-07-05 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Monitoring; Mutation Confirmation; ...
Conditions (1): Help
Solid tumor
Genes (434): Help
ABCB7 (Xq13.3); ABL1 (9q34.12); ABL2 (1q25.2); ABRAXAS1 (4q21.23); ACD (16q22.1) more...
Methods (2): Help
Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Patients with various solid tumors including cancers of the lung, …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Genomic Testing Cooperative, LCA
View lab's website
View lab's test page
Test short name: Help
Solid Tumor Profile Plus
Manufacturer's name: Help
Laboratory Developed Test
Specimen Source: Help
Who can order: Help
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Test Order Code: Help
0003
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

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
Complete Requisition, making sure all sections are completed in their entirety including Client information, Patient Information, Specimen Information and Test Selection. Insure the specimen is labeled with patient name and number. A minimum of two patient identifiers is REQUIRED for each specimen. Diagnosis/Patient History is extremely important in rendering the …
View more
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
    OrderCode: GTC-Hematology Profile, GTC-Hematology Profile Plus Fusion/Expression, GTC-Solid Tumor Profile, GTC-Solid Tumor Fusion/Expression Profile,GTC-Solid Tumor Profile Plus Expression
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
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 434
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument *
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Monitoring; Mutation Confirmation; Prognostic; Therapeutic management
Target population: Help
Patients with various solid tumors including cancers of the lung, pancreas, brain, colon, breast, ovary, endometrium, thyroid, head and neck, and soft tissue (sarcoma and GIST).
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
This is a next generation sequencing (NGS) test that analyzes DNA for abnormalities in 434 genes and RNA in 1385 genes that are reported to be altered in various types of tumors. Nucleic acid is isolated from paraffin-embedded tissue. Testing is performed using massive parallel sequencing of the coding DNA … View more
Test Comments: Help
This is a comprehensive molecular profile which uses next generation sequencing (NGS), fragment length analysis and Sanger Sequencing testing to identify molecular abnormalities in DNA of 434 genes and RNA in 1,385 genes with a focus on 55 genes implicated in solid tumors.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The analytic validity was established with unique variants consisting of 1814 SNVs and 67 indels. The Sensitivity/Variant-level PPA (95% CI) was 0.9895 CI:0.983 to 0.993 for SNVs and 1.0 CI:0.983 to 1.0 for indels. The Specificity/ Variant-level NPA (95% CI) was 1.00 CI: 0.996 to 1.00 for SNVs and 1.00 … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
NYS CLEP Approval: Help
Number:
Status: Pending
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.