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BRAF and MSI Mutation Analysis
Clinical Genetic Test
Help
offered by
PathGroup
View lab's test page
LinkOut
GTR Test Accession: Help GTR000575336.1
CAP
CANCERINHERITED DISEASEDIGESTIVE SYSTEM ... View more
Last updated in GTR: 2020-03-03
View version history
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Test purpose: Help
Predictive; Prognostic; Diagnosis
Conditions (15): Help
Acute myeloid leukemia; Carcinoma of colon; Carcinoma of pancreas; ...
Genes (1): Help
BRAF (7q34)
Methods (2): Help
Molecular Genetics - Microsatellite instability testing (MSI): PCR; ...
Target population: Help
Solid tumor cancer patients including but not limited to NSCLC …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
PathGroup
View lab's website
View lab's test page
Test short name: Help
BRAF_MSI
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Test Order Code: Help
BRAF_MSI
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
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:
Lab contact for this test, Test strategy
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
Predictive; Prognostic; Diagnosis
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:
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
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:
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
Additional Information

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.