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BCR/ABL IS Quant CML and JAK2 V617F Quant and JAK2 … see more BCR/ABL IS Quant CML and JAK2 V617F Quant and JAK2 Exon 12-15  see less
Clinical Genetic Test
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offered by
PathGroup
View lab's test page
LinkOut
GTR Test Accession: Help GTR000575332.1
CAP
HEMATOLOGYCANCERMUSCULOSKELETAL ... View more
Registered 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
Monitoring; Therapeutic management; Diagnosis
Conditions (7): Help
Chronic myelogenous leukemia, BCR-ABL1 positive; Acquired polycythemia vera; Acute lymphoid leukemia more...
Genes (3): Help
ABL1 (9q34.12); BCR (22q11.23); JAK2 (9p24.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: RT-qPCR
Target population: Help
Chronic Myeloid Leukemia, Ph+ Leukemia, Polycythemia vera, essential thrombocythemia, myelofibrosis
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
BCRIS_JAK2_quant_exon12-15
Specimen Source: Help
  • Bone marrow
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Test Order Code: Help
BCRIS_JAK2_quant_exon12-15
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
BCR/ABL_JAK2
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: 7
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 3
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
RT-qPCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Monitoring; Therapeutic management; Diagnosis
Target population: Help
Chronic Myeloid Leukemia, Ph+ Leukemia, Polycythemia vera, essential thrombocythemia, myelofibrosis
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
BCR/ABL1: Analytic sensitivity of approximately 3 copies of the BCR/ABL1 fusion gene. LLOQ of approximately 10 copies of the BCR/ABL1 fusion gene. Specificity of >99%. Linear range to approximately MR4.2. JAK2: Analytic sensitivity of 1%. Analytic specificity of >99%.
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.