GTR Test Accession:
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GTR000603546.1
NYS CLEP
Last updated in GTR: 2022-11-18
View version history
GTR000603546.1, last updated: 2022-11-18
Last annual review date for the lab: 2023-12-27
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At a Glance
Test purpose:
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Drug Response;
Therapeutic management
Conditions (6):
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Genes (2):
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BRCA1 (17q21.31);
BRCA2 (13q13.1)
Methods (2):
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Molecular Genetics - Deletion/duplication analysis: Quantitative PCR; ...
Target population: Help
Ovarian cancer and metastatic breast cancer patients being considered for …
Clinical validity:
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Not provided
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by:
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Specimen Source:
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- Peripheral (whole) blood
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
- Registered Nurse
Contact Policy:
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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:
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Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
Confirmation of research findings
Confirmation of research findings
Test development:
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FDA-reviewed (has FDA test name)
Informed consent required:
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Decline to answer
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
Test Order Code,
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 6
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 2
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 2
Method Category
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Test method
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Instrument
Deletion/duplication analysis
Quantitative PCR
Mutation scanning of the entire coding region
Bi-directional Sanger Sequence Analysis
Applied Biosystems 3730 capillary sequencing instrument
Clinical Information
Test purpose:
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Drug Response;
Therapeutic management
Clinical utility:
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Guidance for selecting a drug therapy and/or dose
View citations (3)
- https://myriad-oncology.com/bracanalysiscdx/
- https://myriad-oncology.com/bracanalysiscdx/
- https://s3.amazonaws.com/myriad-web/BRACAnalysisCDxTS.pdf
Target population:
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Ovarian cancer and metastatic breast cancer patients being considered for treatment with Lynparza™ (olaparib).
View citations (2)
- Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009;361(2):123-34. doi:10.1056/NEJMoa0900212. Epub 2009 Jun 24. PMID: 19553641.
- Applying synthetic lethality for the selective targeting of cancer. McLornan DP, et al. N Engl J Med. 2014;371(18):1725-35. doi:10.1056/NEJMra1407390. PMID: 25354106.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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Classifications are determined by committee decision. The variant classification protocols and databases for BRACAnalysis CDx are regulated by the FDA as part of the companion diagnostic device.
Classifications are determined by committee decision. The variant classification protocols and databases for BRACAnalysis CDx are regulated by the FDA as part of the companion diagnostic device.
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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Yes. Amended reports are sent to ordering/recieving provider at the time of reclassification.
Yes. Amended reports are sent to ordering/recieving provider at the time of reclassification.
Recommended fields not provided:
Clinical validity,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Test Comments:
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Previousy registered in GTR as GTR000521311
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Performance Characteristics 1. Accuracy a. BRACAnalysis CDx™ Sanger Sequencing Test Accuracy BRACAnalysis CDx™ Technical Information https://myriad-library.s3.amazonaws.com/technical-specifications/BRACAnalysis_CDx_Tech_Specs.pdf The accuracy of the BRACAnalysis CDx™ Sanger Sequencing assay was evaluated in this study by comparing its sequencing results with those of a validated NGS assay on a set of 100 blinded, patient blood-derived …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
Internal proficiency test scheme
Description of PT method: Help
Internal proficiency test scheme.
Yes
Method used for proficiency testing: Help
Intra-Laboratory
PT Provider: Help
Internal proficiency test scheme
Description of PT method: Help
Internal proficiency test scheme.
VUS:
Software used to interpret novel variations
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In house developed analytical tools, all of which are regulated by the FDA.
Laboratory's policy on reporting novel variations Help
All non-polymophism variations are reported.
In house developed analytical tools, all of which are regulated by the FDA.
Laboratory's policy on reporting novel variations Help
All non-polymophism variations are reported.
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Category:
IVD - In Vitro Device.
FDA Review of (Item reviewed):
Assay(s)
FDA Regulatory Status:
FDA cleared/approved
Application number:
P140020 S009
Category:
IVD - In Vitro Device.
FDA Review of (Item reviewed):
Assay(s)
FDA Regulatory Status:
FDA cleared/approved
Application number:
P140020 S012
NYS CLEP Approval:
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Number:
5414
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Consumer resources:
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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.