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BCR/ABL CML IS, CALR and JAK2 exon 12-15 (V617F Quant)
Clinical Genetic Test
Help
offered by
PathGroup
View lab's test page
LinkOut
GTR Test Accession: Help GTR000575309.2
CAP
CANCERHEMATOLOGYINHERITED DISEASE ... View more
Last updated in GTR: 2020-03-04
View version history
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis; Monitoring
Conditions (10): Help
Myeloproliferative neoplasm; Acquired polycythemia vera; Acute lymphoid leukemia more...
Genes (4): Help
ABL1 (9q34.12); BCR (22q11.23); CALR (19p13.13); JAK2 (9p24.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR
Target population: Help
Chronic Myeloid Leukemia, Ph+ Leukemia, Acute Lypmpoid Leukemia, ALL, Polycythemia …
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
BCRQT_JAK2v617F_expanded_CALR
Specimen Source: Help
  • Bone marrow
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
Test Order Code: Help
BCRQT_JAK2v617F_expanded_CALR
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
BCRQT_JAK2v617F_expanded_CALR
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
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: 10
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 4
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
PCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Monitoring
Target population: Help
Chronic Myeloid Leukemia, Ph+ Leukemia, Acute Lypmpoid Leukemia, ALL, Polycythemia vera, essential thrombocythemia, myelofibrosis, Myeloproliferative neoplasms
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/ABL: 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 Quant: Analytic sensitivity of 1%. Analytic specificity of >99%. Expanded JAK2: Analytic sensitivity >99% when variant is present at … View more
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.