GTR Test Accession:
Help
GTR000603555.1
CAP
Last updated in GTR: 2022-11-18
View version history
GTR000603555.1, last updated: 2022-11-18
Last annual review date for the lab: 2023-12-27
LinkOut
At a Glance
Test purpose:
Help
Drug Response;
Therapeutic management
Conditions (14):
Help
Vemurafenib response; Cetuximab response; Dabrafenib response; ...
Genes (6):
Help
BRAF (7q34), BRCA1 (17q21.31), BRCA2 (13q13.1), EGFR (7p11.2), ERBB2 (17q12), ...
Methods (3):
Help
Biochemical Genetics - Immunohistochemistry: Gene expression profiling; ...
Target population: Help
Not provided
Clinical validity:
Help
Not provided
Clinical utility:
Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
Help
Test short name:
Help
Precise Tumor
Specimen Source:
Help
- Paraffin block
- View specimen requirements
Who can order: Help
- Physician Assistant
- Health Care Provider
- Licensed Physician
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 test requisition form (available at https://myriad.com/oncology/precise-tumor/) and submit along with at least one tumor block with a cross-sectional tumor area of 25mm containing at least 80 micro meter of tumor. If only tumor slides are available, preparation instructions can be found at https://myriad-library.s3.amazonaws.com/Precise/Precise_Pathology_Guide.pdf
Order URL
Order URL
Test service:
Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development:
Help
Test developed by laboratory (no manufacturer test name)
Informed consent required:
Help
Decline to answer
Pre-test genetic counseling required:
Help
No
Post-test genetic counseling required:
Help
No
Recommended fields not provided:
Test Order Code,
Lab contact for this test,
Test strategy
Conditions
Help
Total conditions: 14
Condition/Phenotype | Identifier |
---|
Test Targets
Genes
Help
Total genes: 6
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
---|
Methodology
Total methods: 3
Method Category
Help
Test method
Help
Instrument *
Immunohistochemistry
Gene expression profiling
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
Drug Response;
Therapeutic management
Clinical utility:
Help
Guidance for selecting a drug therapy and/or dose
View citations (1)
- Conroy JM, Pabla S, Glenn ST, Seager RJ, Van Roey E, Gao S, Burgher B, Andreas J, Giamo V, Mallon M, Lee YH, DePietro P, Nesline M, Wang Y, Lenzo FL, Klein R, Zhang S. A scalable high-throughput targeted next-generation sequencing assay for comprehensive genomic profiling of solid tumors. PLoS One. 2021;16(12):e0260089. doi:10.1371/journal.pone.0260089. Epub 2021 Dec 02. PMID: 34855780.
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
Help
No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
Help
No.
No.
Recommended fields not provided:
Clinical validity,
Target population,
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 Comments:
Help
Previousy registered in GTR as GTR000597554
Availability:
Help
Tests performed
Specimen preparation performed in-house
Interpretation performed at an outside lab
Wet lab work performed at an outside lab
Report generated in-house
Test performance comments
Specimen preparation and report generation are performed in house. Wet lab work is performed by Intermountain Precision Genomics, a service of Intermountain Healthcare. Interpretation is done in collaboration with Pieriandx.
Specimen preparation performed in-house
Interpretation performed at an outside lab
Wet lab work performed at an outside lab
Report generated in-house
Test performance comments
Specimen preparation and report generation are performed in house. Wet lab work is performed by Intermountain Precision Genomics, a service of Intermountain Healthcare. Interpretation is done in collaboration with Pieriandx.
Analytical Validity:
Help
https://myriad-library.s3.amazonaws.com/Precise/Precise+Tumor+Detailed+Sales+Aid.pdf
Proficiency testing (PT):
Is proficiency testing performed for this test?
Help
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, 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
Not provided
NYS CLEP Approval:
Help
Number:
Status: Pending
Status: Pending
Additional Information
Clinical resources:
Molecular resources:
Practice guidelines:
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.