BRACAnalysis CDx®
Companion Diagnostic
BRACAnalysis CDx® is an FDA-approved companion diagnostic used to help identify patients who may be eligible for targeted therapies.
Use
BRACAnalysis CDx® is an in vitro diagnostic device intended for qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of BRCA1 and BRCA2 using genomic DNA obtained from whole blood collected in EDTA. Results are used as an aid in identifying breast, ovarian, pancreatic, and prostate cancer patients with deleterious or suspected deleterious germline BRCA1/2 mutations who are or may become eligible for treatment with therapies referenced in the Technical Information.
Special Instructions
A sample collection kit is used for ordering and blood collection. To order testing, the Test Request Form (TRF) included in the kit must be fully completed. Follow the Collection Instructions and Mailing Instructions included with the kit for blood collection and sample submission.
Limitations
Patients who have undergone a previous allogeneic bone marrow transplant should not be tested. The test is designed to detect germline BRCA1/2 variants within specific regions; variants outside assessed regions will not be detected. Performance was not evaluated for deletions larger than 5 nucleotides and small insertions using the Sanger sequencing component. The large rearrangement component targets deletions/duplications involving promoter and coding exons and may not detect some types of RNA transcript processing errors.
FDA ApprovedNew York ApprovedCompanion Diagnostic
Methodology
Sanger (WES)
Biomarkers
BRCA1
GeneBRCA2
Gene
Result Turnaround Time
7-14 days
Related Documents
Not provided.
Specimen
Whole Blood
Volume
Not provided
Minimum Volume
Not provided
Patient Preparation
Not specified
Other tests from different labs that may be relevant