OnkoSight Advanced Bladder Cancer Panel
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000607871.1
NYS CLEP
CAP
BREAST DISORDERSCANCER
Last updated in GTR: 2023-05-22
Last annual review date for the lab: 2024-01-12 LinkOut
At a Glance
Diagnosis; Drug Response; Predictive; ...
Malignant tumor of breast
ARID1A (1p36.11), ATM (11q22.3), BRAF (7q34), BRCA2 (13q13.1), CCND1 (11q13.3), ...
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Bladder Cancer
Not provided
Not provided
Ordering Information
Offered by: Help
Specimen Source: Help
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
TP51
How to Order: Help
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 39
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
Bladder Cancer
Recommended fields not provided:
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:
Regulatory Approval
FDA Review: Help
Category: Not Applicable
NYS CLEP Approval: Help
Number: 50555
Status: Approved
Additional Information

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