BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.

Results of the test are used as an aid in identifying patients who are or may become eligible for treatment for targeted therapies. See intended use statement for complete details.

 


Mechanism of Action: BRCA and PARP

1

Normal Cells: endogenous DNA damage


polyADP ribose polymerase (PARP) and BRCA both function to repair DNA

2

Tumor Cells: DNA damage


Tumors with BRCA mutations already have a DNA repair defect

3

Tumor Cells: DNA damage


Inhibiting PARP in BRCA deficient cells prevents the cell from replicating- effectively killing the cancer cells


BRACAnalysis CDx is intended to detect germline BRCA1 and BRCA2 variants and provide a clinical interpretation of the identified variants.

All components are incorporated in Myriad’s FDA-approved device.