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MultiSite 3 BRACAnalysis
Clinical Genetic Test
Help
offered by
Myriad Genetics, Inc.
View lab's test page
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GTR Test Accession: Help GTR000603550.1
NYS CLEP
CANCERSYNDROMIC DISEASEINHERITED DISEASE ... View more
Registered in GTR: 2022-11-18
View version history
Last annual review date for the lab: 2024-12-18 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Mutation Confirmation; Pre-symptomatic; ...
Conditions (1): Help
Hereditary breast ovarian cancer syndrome
Genes (2): Help
BRCA1 (17q21.31); BRCA2 (13q13.1)
Methods (1): Help
Molecular Genetics - Sequence analysis of select exons: Bi-directional Sanger Sequence Analysis
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Myriad Genetics, Inc.
View lab's website
View lab's test page
Specimen Source: Help
  • Fibroblasts
  • Peripheral (whole) blood
  • Saliva
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
Contact Policy: Help
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order: Help
Licensure is state dependant. All healthcare providers who are licenced to order genetic testing in their state may order this testing.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Confirmation of research findings
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 2
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of select exons
Bi-directional Sanger Sequence Analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Mutation Confirmation; Pre-symptomatic; Risk Assessment
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Classifications are determined by committee decision.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help
Yes.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes. Amended reports are sent to ordering/recieving provider at the time of reclassification.
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
All potential clinically significant variants are independently confirmed by repeated PCR amplification of the indicated gene region(s) and sequencing or deletion/duplication testing, depending on the mutation.
Test Confirmation: Help
All potential clinically significant variants are independently confirmed by repeated PCR amplification of the indicated gene region(s) and sequencing or deletion/duplication testing, depending on the mutation.
Test Comments: Help
Previousy registered in GTR as GTR000503369
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytical specificity: The incidence of a false report of a genetic variant or mutation resulting from technical error is considered negligible because of independent confirmation of all genetic variants. The incidence of a false report of a genetic variant or mutation resulting from errors in specimen handling and tracking is … View more
View citations (2)
Assay limitations: Help
Limitations of method: There may be limited portions of either BRCA1 or BRCA2 for which sequence determination can be performed only in the forward or reverse direction. Unequal allele amplification may result from rare polymorphisms under primer sites. Comprehensive BRACAnalysis includes testing for only the five specific large genomic rearrangements … View more
View citations (2)
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

Description of internal test validation method: Help
Blinded internal proficiency testing
VUS:
Software used to interpret novel variations Help
In house developed analytical tools.

Laboratory's policy on reporting novel variations Help
All non-polymophism variations are reported.
Recommended fields not provided:
Citations to support internal test validation method, 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: 5414
Status: Approved
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.