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ALK ROS1 Fusion Test
Clinical Genetic Test
Help
offered by
Circulogene Theranostics
GTR Test Accession: Help GTR000566698.1
CANCERRESPIRATORY DISEASE
Last updated in GTR: 2019-04-04
View version history
Last annual review date for the lab: 2022-04-08 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis; Drug Response; Monitoring; ...
Conditions (5): Help
Lung carcinoma; EGFR-related lung cancer; GSTM1-related lung cancer more...
Genes (2): Help
ALK (2p23.2-23.1); ROS1 (6q22.1)
Methods (1): Help
Molecular Genetics - RNA analysis: RT-qPCR
Target population: Help
Lung cancer patients
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Circulogene Theranostics
View lab's website
Test short name: Help
ALK ROS1 Fusion
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Contact Policy: Help
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
How to Order: Help
Please call 205-278-1601/855-614-7083 or email info@circulogene.com for ordering details.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Liquid Biopsy NGS Testing
Test additional service: Help
Custom mutation-specific/Carrier testing
Test development: Help
Test developed by laboratory (no manufacturer 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: 5
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: 1
Method Category Help
Test method Help
Instrument
RNA analysis
RT-qPCR
Applied Biosystems 7900HT Sequence Detection System
Clinical Information
Test purpose: Help
Diagnosis; Drug Response; Monitoring; Therapeutic management
Target population: Help
Lung cancer patients
View citations (1)
  • ALK and ROS1 as a joint target for the treatment of lung cancer: a review. Puig de la Bellacasa R, et al. Transl Lung Cancer Res. 2013;2(2):72-86. doi:10.3978/j.issn.2218-6751.2013.03.1. PMID: 25806218.
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
Test Platform:
TaqMan
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
In a test accuracy study, a total of 29 samples from lung cancer patients that had been analyzed using either FISH (Fluorescence in situ hybridization), digital droplet PCR or real-time PCR at other reference laboratories were re-tested using Circulogene ALK/ROS1 Gene Fusion assay. All samples gave 100% agreement.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Inter-Laboratory
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: Help
Category: Not Applicable
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.