Quantitative BCR-ABL1 p210 gene rearrangement
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000531526.5
CAP
IMMUNOLOGYINHERITED DISEASECANCER ... View more
Last updated in GTR: 2021-04-29
Last annual review date for the lab: 2024-04-29 LinkOut
At a Glance
Diagnosis; Monitoring
Chronic myelogenous leukemia, BCR-ABL1 positive
Molecular Genetics - RNA analysis: RT-qPCR
Not provided
Not provided
Not provided
Ordering Information
Offered by: Help
Molecular Genetics Diagnostic Laboratory
View lab's website
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Lab contact: Help
Melissa Hicks, MS, CGC, Certified Genetic counselor, CGC, Genetic Counselor
mhicks@dmc.org
313-993-2880
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.
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test development: Help
Modified FDA (has FDA-reviewed entry, but with lab modifications/field changes)
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:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Chromosomal regions/Mitochondria Help
Total chromosomal regions/mitochondria: 1
Chromosomal region/Mitochondrion Associated condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
RNA analysis
RT-qPCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Monitoring
Recommended fields not provided:
Technical Information
Test Comments: Help
Detects the BCR-ABL1 major (p210) fusion transcript
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Limit of Detection: <0.002% IS, MR>4.7
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:
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: K173492
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.