BRACAnalysis CDx®

Personalizing treatment decisions in breast and ovarian cancer

BRACAnalysis CDx® is an FDA-approved laboratory developed test for BRCA1 and BRCA2 intended to inform patient management related to the PARP inhibitors in accordance with the approved therapeutic product labeling.1,2

BRACAnalysis CDx

Mutations in BRCA1 and BRCA2 are known to cause Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. For more than 20 years, Myriad has been dedicated to understanding mutations in these genes as well as reducing the overall variant of uncertain significance rate to ensure that all patients receive answers. Increasing knowledge over the last several years about these genes has changed medical management and now mutations in BRCA1 and BRCA2 genes are used to inform patient management related to the PARP inhibitors in accordance with the approved therapeutic product labeling.1,2

BRACAnalysis CDx STS Box_05_05_22_REND3D

Intended use – PMA intended use statement for BRACAnalysis CDx

Intended use

PMA intended use statement for BRACAnalysis CDx

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 with the targeted therapies in accordance with the approved therapeutic product labeling.

This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108

Limitation: in ovarian cancer, ~70% of tumor BRCA1 and BRCA2 mutation positive patients are estimated to have a germline mutation while ~30% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from a patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in ovarian cancer patients does not rule out the possibility of a somatic BRCA1 and BRCA2 mutation in tumor tissue from these patients.

Limitation: in prostate cancer, ~50% of tumor BRCA1 and BRCA2 mutation positive patients are estimated to have a germline mutation while ~50% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in prostate cancer patients does not rule out the possibility of a somatic BRCA1 and BRCA2 mutation in tumor tissue from these patients.

LYNPARZA is a registered trademark of the AstraZeneca group of companies.

References

1. Review Intended Use Statement

2. For more detailed information about Lynparza and its safety and efficacy please go to lynparza.com

Lynparza is a registered trademark of the AstraZeneca group of companies.