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Otogenetics Hereditary Cancers
Clinical Genetic Test
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offered by
Otogenetics
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GTR Test Accession: Help GTR000552245.4
CAP
INHERITED DISEASECANCERINHERITED DISEASE SUSCEPTIBILITY ... View more
Last updated in GTR: 2021-03-08
View version history
Last annual review date for the lab: 2022-04-15 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis; Predictive; Risk Assessment; ...
Conditions (36): Help
Hereditary cancer-predisposing syndrome; Breast and colorectal cancer; Breast and colorectal cancer, susceptibility to more...
Genes (39): Help
APC (5q22.2); ATM (11q22.3); BARD1 (2q35); BMPR1A (10q23.2); BRCA1 (17q21.31) more...
Methods (1): Help
Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Individuals and families who wish to understand their risk of …
Clinical validity: Help
Not provided
Clinical utility: Help
Predictive risk information for patient and/or family members
Ordering Information
Offered by: Help
Otogenetics
View lab's website
View lab's test page
Test short name: Help
Inherited Cancer Panel
Specimen Source: Help
Who can order: Help
  • Licensed Physician
  • Physician Assistant
Test Order Code: Help
Oto-InhCa-gtr
View other test codes
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
Yes
Test strategy: Help
Next Generation Sequencing
Pre-test genetic counseling required: Help
Yes
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Lab contact for this test
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
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument
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
http://www.otogenetics.com/forms/Variant-Filtration-Criteria-Inherited-Cancer-Panel-FINAL.docx

Will the lab re-contact the ordering physician if variant interpretation changes? Help
No.
Recommended fields not provided:
Clinical validity, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
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
Yes

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
VUS:
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
http://www.otogenetics.com/forms/Variant-Filtration-Criteria-Inherited-Cancer-Panel-FINAL.docx
Recommended fields not provided:
Assay limitations, Description of internal test validation method, Citations for Analytical validity, Major CAP category, CAP category, CAP test list
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.