OncoAlly® BRCA1/2 Analysis

OA014

OncoAlly® BRCA1/2 Analysis is a diagnostic test designed to identify genetic variants associated with hereditary breast or ovarian cancer in BRCA1 or BRCA2 genes.

Test Description

OncoAlly® BRCA1/2 Analysis is a targeted test that uses a whole genome platform to detect all major clinically relevant variant types from a single sample. This targeted test focuses on the BRCA1 and BRCA2 genes. Germline variants in BRCA1/2 are associated with hereditary breast, ovarian, pancreatic and prostate cancer.

For both of the targeted genes, OncoAlly® BRCA1/2 Analysis sequences and analyzes the entire gene. In comparison, most other hereditary cancer tests only sequence and analyze targeted regions of the gene, typically exons and selected intronic regions.

Having the full gene sequence allows us to detect all clinically relevant variant types with high specificity and sensitivity, including deletions, duplications, insertions and inversions of any size.

When to Order

Order this test when:

  • A patient has a personal history of breast, ovarian, pancreatic or prostate cancer.
  • A patient has a medical or family history suggestive of breast, ovarian, pancreatic or prostate cancer predisposition.
  • Germline variant analysis for hereditary breast, ovarian, pancreatic or prostate cancer predisposition is necessary to guide medical management.

Included Genes

BRCA1, BRCA2

View a list of cancers associated with each gene.

Included Analyses

  • Sequence analysis of BRCA1 and BRCA2 genes including: single nucleotide variants, deletions, insertions, and characterized intronic variants.
  • Copy number variant analysis of BRCA1 and BRCA2 genes including: duplications/deletions, mobile element insertions, and inversions.

    Turnaround Time

    A report will be issued within 2-4 weeks from receipt of required samples. Turnaround time begins when samples and all required documents and approvals are received.

    Sample Types

    CPT Codes

    81162

    The CPT codes provided are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

    Methods and Limitations

    OncoAlly® BRCA1/2 Analysis uses a PCR-free whole genome sequencing (WGS) platform paired with our Genomic Intelligence® analytical software.

    SNVs:
    99.9% sensitivity
    100% specificity
    99.8% positive predictive value

    Structural variants:
    96% clinical sensitivity