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OnkoSight Advanced Breast Cancer Panel
Clinical Genetic Test
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offered by
BioReference Health
View lab's test page
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GTR Test Accession: Help GTR000607870.1
NYS CLEP
CAP
BREAST DISORDERSCANCER
Registered in GTR: 2023-05-22
View version history
Last annual review date for the lab: 2024-01-12 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Drug Response; Predictive; ...
Conditions (1): Help
Malignant tumor of breast
Genes (50): Help
AKT1 (14q32.33); AR (Xq12); ATM (11q22.3); ATR (3q23); ATRX (Xq21.1) more...
Methods (1): Help
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with Breast Cancer
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
BioReference Health
View lab's website
View lab's test page
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
TP57
How to Order: Help
Order URL
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Specimen source, Lab contact for this test, Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 50
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)
Other
Clinical Information
Test purpose: Help
Diagnosis; Drug Response; Predictive; Prognostic; Therapeutic management
Target population: Help
Patients with Breast Cancer
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
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
Yes

Method used for proficiency testing: Help
Inter-Laboratory

PT Provider: Help
College of American Pathologists, 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: Not Applicable
NYS CLEP Approval: Help
Number: 50555
Status: Approved
Additional Information

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