Clinical Genetic Test
offered by
GTR Test Accession: Help GTR000569749.1
Last updated in GTR: 2019-12-21
Last annual review date for the lab: 2021-09-17 Past due LinkOut
At a Glance
Predictive; Risk Assessment
Urinary bladder carcinoma; Papillary renal cell carcinoma type 1
EPCAM (2p21); FH (1q43); FLCN (17p11.2); MET (7q31.2); MLH1 (3p22.2) more...
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Patients with personal and/or familial history of cancer
Not provided
Not provided
Ordering Information
Offered by: Help
Test short name: Help
Manufacturer's name: Help
Illumina TruSight Cancer sequencing panel with the TruSight Rapid Capture kit
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
  • Registered Nurse
Test Order Code: Help
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.
How to Order: Help
Ordering provider must fill up a Family History Form for each patient; this form, along with the Provider Assessment Guide, will assist the provider to determine whether the patient meets the established NCCN guidelines for being tested. If patient qualifies, the provider will fill up the requisition form and collect …
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Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
Test additional service: Help
Custom mutation-specific/Carrier testing
Informed consent required: Help
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Recommended fields not provided:
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 14
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 1
Method Category Help
Test method Help
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina MiSeqDx
Clinical Information
Test purpose: Help
Predictive; Risk Assessment
Target population: Help
Patients with personal and/or familial history of cancer
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
IntelligeneCG laboratory has a proprietary data analysis pipeline for analysis, which includes the standards and guidelines established by the American College of Medical Genetics and Genomics (ACMGG). IntelligeneCG also follows recommendations from professional societies such as American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network, among others.

Are family members with defined clinical status recruited to assess significance of VUS without charge? Help

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes. The laboratory scientific director or laboratory manager will contact the ordering provider by phone to inform that there is a change in the classification and will issue an updated report for the provider. The updated report will describe the changes that have occurred and the implications for the patient, if … View more
Recommended fields not provided:
Technical Information
Test Procedure: Help
Illumina TruSight Cancer sequencing panel with the TruSight Rapid Capture kit
Test Confirmation: Help
Confirmatory analysis performed for Pathogenic, Likely Pathogenic or Low Coverage variants
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
This is a qualitative assay that uses the commercially available TruSight Cancer sequencing panel with the TruSight Rapid Capture kit from Illumina. As this test is a qualitative assay for genetic predisposition of cancer and genetic content is unique to each individual, the validation requirements for the reference range performance … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
Software used to interpret novel variations Help
Proprietary Internal Software

Laboratory's policy on reporting novel variations Help
Novel variations are reported as routine report to the ordering provider. All the reports are written and curated before publication by a team of scientists to assure that the report conveys the most recent and proper knowledge to assist the ordering provider in the clinical management.
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Not provided
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.