BRAF and MSI Mutation Analysis
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000575336.1
CAP
CANCERINHERITED DISEASEDIGESTIVE SYSTEM ... View more
Registered in GTR: 2020-03-03
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Diagnosis; Predictive; Prognostic
Acute myeloid leukemia; Carcinoma of colon; Carcinoma of pancreas more...
Genes (1): Help
BRAF (7q34)
Molecular Genetics - Microsatellite instability testing (MSI): PCR; ...
Solid tumor cancer patients including but not limited to NSCLC …
Not provided
Not provided
Ordering Information
Test short name: Help
BRAF_MSI
Specimen Source: Help
  • Paraffin block
Who can order: Help
  • Health Care Provider
Test Order Code: Help
CPT codes: Help
**AMA CPT codes notice
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
BRAF_MSI
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 15
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument *
Microsatellite instability testing (MSI)
PCR
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Predictive; Prognostic
Target population: Help
Solid tumor cancer patients including but not limited to NSCLC and CRC. Patients with microsatellite instable tumors to resolve germline vs sporadic source. Solid tumor patients exploring certain immune checkpoint blockade therapies
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
BRAF: Analytic sensitivity >99% when variant is present at >5% VAF with minimum of 20% tumor cells. Analytic specificity of >99%. Precision and reproducibility of >98%. MSI: Analytic sensitivity is approximately 5%. Analytic specificity >98%.
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:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

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