Confidently Recommend an Appropriate PARP Inhibitor with Fast and Accurate BRCA1/2 Results

Germline BRCA1 and BRCA2 status is a critical biomarker to help you determine the appropriate therapy for your patients with metastatic breast, ovarian, metastatic pancreatic, and metastatic prostate cancer. BRACAnalysis CDx® was designed to quickly provide accurate results so you can confidently recommend the next treatment for your patient without delay.

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Fast Results

Results in 14 days or less

Better Coverage

FDA-approved with Medicare coverage

Accurate Answers

Industry leading and independently verified lab accuracy

FDA-Approved Targeted Therapies

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

TALZENNA™ (TALAZOPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

RUBRACA® (RUCAPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

TALZENNA™ (TALAZOPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

RUBRACA® (RUCAPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

BIOMARKER

Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes

FDA APPROVED THERAPY

LYNPARZA® (OLAPARIB)

The Importance of Variant Classification

43-63% of germline BRCA mutations identified as VUSs at competing labs can be definitively classified using Myriad’s variant classification program1.

Myriad has over 25 years of experience in variant classification of BRAC1/2. The resulting analysis and interpretation of the variants reduces VUS in genetic test results and provides confidence for oncologists when determining the appropriate therapy for their patients.

Testing to Treat Requires Faster Results

We understand that you need your patients’ germline BRCA1/2 status quickly to minimize your patients’ anxiety while they wait for a result and to get them on treatment. BRACAnalysis CDx can report your patients’ germline BRCA1/2 status in less than two weeks after we receive the sample.

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Sources:
  1. Gradishar W, et al. Clinical variant classification: a comparison of public databases and a commercial testing laboratory. Oncologist. 2017;22(7):797-803.

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 TypeBiomarkerTherapy
Breast CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Talzenna® (talazoparib)
Ovarian CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)-
treatment/maintenance
Rubraca® (rucaparib)
Pancreatic CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Prostate CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (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.