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myChoice CDx
Clinical Genetic Test
Help
offered by
Myriad Genetics, Inc.
View lab's test page
LinkOut
GTR Test Accession: Help GTR000603548.1
NYS CLEP
INHERITED DISEASECANCERENDOCRINOLOGY ... View more
Registered in GTR: 2022-11-18
View version history
Last annual review date for the lab: 2023-12-27 LinkOut
At a Glance
Test purpose: Help
Drug Response; Therapeutic management
Conditions (1): Help
Ovarian cancer
Genes (2): Help
BRCA1 (17q21.31); BRCA2 (13q13.1)
Methods (2): Help
Molecular Genetics - Detection of homozygosity: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Target population: Help
Ovarian cancer patients being considered for treatment with Zejula or …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
Myriad Genetics, Inc.
View lab's website
View lab's test page
Specimen Source: Help
  • FFPE tumor tissue
  • Paraffin block
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
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
Order URL
Test development: Help
FDA-reviewed (has FDA 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: 2
Method Category Help
Test method Help
Instrument *
Detection of homozygosity
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)

Target population: Help
Ovarian cancer patients being considered for treatment with Zejula or Lynparza.
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
Decline to answer.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes. Amended reports are sent to ordering/receiving 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: Help
Previousy registered in GTR as GTR000569915
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
A total of 1,733/1,733 valid BRCA1/2 sequence variant test calls were observed compared to the valid reference (comparator) BRCA1/2 sequence variant calls with greater than or equal to 10% allele frequencies across all samples evaluated. This corresponds to a positive percent agreement (PPA) of 100%. Including variants with <10% allele … View more
View citations (1)
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Intra-Laboratory
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:
Test Confirmation, Assay limitations, Description of internal test validation method, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Assay(s)
FDA Regulatory Status: FDA cleared/approved
Application number: P190014
NYS CLEP Approval: Help
Number: 61140
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.