Otogenetics Hereditary Cancers
Clinical Genetic Test
offered by
GTR Test Accession: Help GTR000552245.4
Last updated in GTR: 2021-03-08
Last annual review date for the lab: 2022-04-15 Past due LinkOut
At a Glance
Diagnosis; Predictive; Risk Assessment; ...
Hereditary cancer-predisposing syndrome; Breast and colorectal cancer; Breast and colorectal cancer, susceptibility to; ...
APC (5q22.2), ATM (11q22.3), BARD1 (2q35), BMPR1A (10q23.2), BRCA1 (17q21.31), ...
Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Individuals and families who wish to understand their risk of …
Not provided
Predictive risk information for patient and/or family members
Ordering Information
Offered by: Help
Test short name: Help
Inherited Cancer Panel
Specimen Source: Help
Who can order: Help
  • Licensed Physician
  • Physician Assistant
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
download test requisition form and submit sample according to instructions.
Order URL
Test service: Help
Clinical Testing/Confirmation of Mutations Identified Previously
    OrderCode: Oto-InhCa-gtr
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
Test strategy: Help
Next Generation Sequencing
Pre-test genetic counseling required: Help
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 36
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 39
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 1
Method Category Help
Test method Help
Sequence analysis of select exons
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Illumina Novaseq
Clinical Information
Test purpose: Help
Diagnosis; Predictive; Risk Assessment; Screening
Clinical utility: Help
Predictive risk information for patient and/or family members
View citations (1)
  • Hereditary cancer predisposition syndromes. Garber JE, et al. J Clin Oncol. 2005;23(2):276-92. doi:10.1200/JCO.2005.10.042. PMID: 15637391.

Target population: Help
Individuals and families who wish to understand their risk of developing certain types of cancer
View citations (1)
  • Genetic testing for cancer predisposition. Eng C, et al. Annu Rev Med. 2001;52:371-400. doi:10.1146/annurev.med.52.1.371. PMID: 11160785.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Recommended fields not provided:
Technical Information
Test Procedure: Help
Select loci validated via Sanger
Test Platform:
Custom designed gene panel
Test Confirmation: Help
Select loci validated via Sanger
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Target coverage of 100%. CAP Proficiency testing – 100%. Select loci validated against Sanger- 100% match.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP

Description of PT method: Help
Next Generation Sequencing
Software used to interpret novel variations Help
Reported variants were filtered to include those present in the targeted coding exonic regions and adjacent splice sites. Resulting variants were analyzed and reported using the Variantyx Genomic Intelligence platform. To maintain most up-to-date annotations, the Variantyx database is updated quarterly. As a result, variant classification and/or interpretation may change … View more

Laboratory's policy on reporting novel variations Help
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
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.