OnkoRisk Women's Hereditary Cancer Panel
Clinical Genetic Test
Help
offered by
GTR Test Accession: Help GTR000613041.1
CANCERINHERITED DISEASEDIGESTIVE SYSTEM ... View more
Last updated in GTR: 2023-10-20
Last annual review date for the lab: 2024-01-12 LinkOut
At a Glance
Diagnosis; Predictive; Risk Assessment
Solid tumor; Ataxia-telangiectasia syndrome; Breast adenocarcinoma more...
ATM (11q22.3); BARD1 (2q35); BRCA1 (17q21.31); BRCA2 (13q13.1); BRIP1 (17q23.2) more...
Molecular Genetics - Sequence analysis of the entire coding region: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Patients with a personal or family history of breast, ovarian, …
Clinical validity is dependent on individual patient clinical picture and …
Not provided
Ordering Information
Offered by: Help
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
  • Nurse Practitioner
  • Physician Assistant
Test Order Code: Help
TP67
CPT codes: Help
**AMA CPT codes notice
Lab contact: Help
Sarah Witherington, MS, Certified Genetic counselor, CGC, Genetic Counselor
switherington@bioreference.com
224-250-3416
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.
Post-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Pre-test email/phone consultation regarding genetic test results and interpretation is provided to patients/families.
Test service: Help
Genetic counseling
    OrderCode: TQ06, TQ07
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
Based on applicable state law
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 34
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 18
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)
Illumina NovaSeq
Clinical Information
Test purpose: Help
Diagnosis; Predictive; Risk Assessment
Clinical validity: Help
Clinical validity is dependent on individual patient clinical picture and family history of disease.
Target population: Help
Patients with a personal or family history of breast, ovarian, pancreatic, prostate, or colon cancer who wish to know their risk for developing a hereditary cancer. Based on ACOG recommendations.
Variant Interpretation:
Will the lab re-contact the ordering physician if variant interpretation changes? Help
Yes.
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. Analytical Sensitivity: 100% (for SNVs and Indels at 4% VAF and gene amplification) Analytical Specificity: > 98.3% for Indels. >99.8% for SNVs
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Internal and formal PT
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Not provided
NYS CLEP Approval: Help
Number:
Status: Pending
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.