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OnkoSight Advanced Comprehesive Lung
Clinical Genetic Test
Help
offered by
BioReference Health
GTR Test Accession: Help GTR000603924.1
INHERITED DISEASECANCERRESPIRATORY DISEASE ... View more
Registered in GTR: 2023-01-16
View version history
Last annual review date for the lab: 2024-01-12 LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (1): Help
Lung cancer
Genes (33): Help
AKT1 (14q32.33); ALK (2p23.2-23.1); ATR (3q23); AXL (19q13.2); BRAF (7q34) more...
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
BioReference Health
View lab's website
Specimen Source: Help
  • Isolated DNA
  • Unstained slides
  • Paraffin block
Who can order: Help
  • Health Care Provider
Test Order Code: Help
TK78
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 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
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
How to Order, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 33
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, 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: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Limit of detection: 4% VAF for small variants. 1.5x, 3x, and 5x fold changes for ERBB2, MET, and EGFR, respectively; fold changes for other genes are reported if in excess of 2.5x. Analytical Sensitivity: 100% (for SNVs and Indels at 4% VAF and gene amplification) Analytical Specificity: > 98.3% for … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
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: Help
Not provided
Additional Information
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.