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Breast cancer guidelines have changed.
Have your testing practices?

Treating breast cancer patients can be complex. Knowing who needs germline testing doesn’t have to be. Results from the OlympiA trial expand frontline options for high-risk BRCA mutated breast cancer patients. The FDA has approved BRACAnalysis CDx® for use as a companion diagnostic to identify patients with germline BRCA-mutated (gBRCAm) HER2 negative high-risk early-stage breast cancer who may benefit from treatment with LYNPARZA® (olaparib).

Guidelines agree, the OlympiA trial identified important frontline options for high-risk patients with breast cancer.

Download the OlympiA Clinical Summary

Every patient deserves an answer. Now you can provide one. Germline testing with Myriad Genetics can help you provide results for your breast cancer patients.

FDA-approved BRACAnalysis CDx can identify patients with germline BRCA-mutated HER2-negative high-risk, early-stage breast cancer.

Learn more about BRACAnalysis CDx

Why should I do somatic and germline testing?

Hear how Dr. Sharyn Lewin uses germline testing in conjunction with somatic testing to help guide treatment decisions.



How To Order

To request reflex testing, for patients who test negative for BRCA1/2 mutations simply check the box for MyRisk™ on the test request form. This will provide an analysis of additional germline cancer genes for patients who have been testing with BRACAnalysis CDx.

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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 listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1: Companion diagnostic indications

Tumor Type Biomarker Therapy
Breast Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes LYNPARZA® (olaparib)
Talzenna® (talazoparib)
Ovarian Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes LYNPARZA® (olaparib)-
treatment/maintenance
Rubraca® (rucaparib)
Pancreatic Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes LYNPARZA® (olaparib)
Prostate Cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes LYNPARZA® (olaparib)

Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) or Rubraca® (rucaparib) maintenance therapy.

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 or 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 or BRCA2 mutation in tumor tissue from these patients.

Limitation: In Prostate Cancer, ~50% of tumor BRCA1 or 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 or BRCA2 mutation in tumor tissue from these patients.

Limitation: In Prostate Cancer, ~50% of tumor BRCA1 or 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 or BRCA2 mutation in tumor tissue from these patients.

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

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