OncoAlly™ BRCA1/2 Analysis Analysis
Clinical Genetic Test
offered by
GTR Test Accession: Help GTR000607872.1
Last updated in GTR: 2023-05-23
Last annual review date for the lab: 2024-01-30 LinkOut
At a Glance
Hereditary cancer-predisposing syndrome; Hereditary cancer
Genes (2): Help
BRCA1 (17q21.31), BRCA2 (13q13.1)
Molecular Genetics - Deletion/duplication analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS); ...
Patients with personal or family history suggestive of one or …
Not provided
Not provided
Ordering Information
Offered by: Help
Manufacturer's name: Help
OncoAlly™ BRCA1/2 Analysis Analysis
Specimen Source: Help
Who can order: Help
  • Genetic Counselor
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
CPT codes: Help
**AMA CPT codes notice
Lab contact: Help
Christine Stanley, PhD, FACMG, Medical Director
+1 617-209-2090
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
Test orders are initiated at https://www.variantyx.com/resources/provider-resources/order-forms/. Following submission, a clinical coordinator will get in touch to send a blood or saliva sample collection kit if required and facilitate collection of the test requisition and informed consent forms.
Order URL
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 2
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 2
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 2
Method Category Help
Test method Help
Instrument *
Deletion/duplication analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Sequence analysis of the entire coding region
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Target population: Help
Patients with personal or family history suggestive of one or more hereditary cancer predisposition syndromes or when germline variant analysis for hereditary cancer predisposition is necessary to guide medical management.
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
Variants are categorized as pathogenic, likely pathogenic or a variant of uncertain significance (VUS) utilizing the American College of Medical Genetics and Genomics (ACMG)/Association for Molecular Pathology (AMP) guidelines as published by Richards et al 2015.

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The OncoAlly™ BRCA1/2 Analysis is a whole genome sequence based test designed to identify variants in BRCA1 and BRCA2 genes. This analysis includes sequence analysis (single nucleotide variants, deletions/insertions and characterized intronic variants); copy number variants, duplications/deletions, mobile element insertions, and inversions in BRCA1 and BRCA2. The sensitivity, specificity and … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help

Method used for proficiency testing: Help
Software used to interpret novel variations Help
Variantyx Genomic Intelligence®

Laboratory's policy on reporting novel variations Help
Test results will only be released to the ordering healthcare provider and additional healthcare provider(s) indicated on the test requisition form.
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.