GTR Test Accession:
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GTR000561701.1
Registered in GTR:
2018-09-10
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GTR000561701.1,
registered in GTR:
2018-09-10
Last annual review date for the lab: 2024-07-09
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At a Glance
Test purpose:
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Screening
Conditions (60):
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Chronic myelogenous leukemia, BCR-ABL1 positive;
Acute lymphoid leukemia;
Acute promyelocytic leukemia
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Genes (50):
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Methods (1):
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Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
This panel is used to determine the genetic information (somatic …
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test Order Code:
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6231
Contact Policy:
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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.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
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:
How to Order,
Specimen source,
Lab contact for this test,
Test strategy,
Test development
Conditions
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Total conditions: 60
| Condition/Phenotype | Identifier |
|---|
Test Targets
Genes
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Total genes: 50
| Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
|---|
Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Screening
Target population:
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This panel is used to determine the genetic information (somatic mutations) of a specific cancer or tumor, so that a physician, genetic counselor, or other health provider can offer the optimal treatment plan for a cancer patient.The variants detected in this assay are associated with many known cancers including breast, …
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Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
Are family members with defined clinical status recruited to assess significance of VUS without charge?,
Will the lab re-contact the ordering physician if variant interpretation changes?,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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The limit of detection is 3.5% allele frequency at 500X coverage and 5% allele frequency at 200X coverage. This technology cannot reliably detect mutations at coverage below 200X. Confirmation of actionable mutations should be performed by Sanger sequencing.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
No
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Not provided
Additional Information
Reviews:
Clinical resources:
Practice guidelines:
Consumer resources:
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.