BRCA Testing for
Pancreatic Cancer

Determine which Patients with Pancreatic Cancer Are Appropriate For PARP Inhibitor Therapy

PARP inhibitor therapy is an effective treatment option for patients with metastatic pancreatic cancer and germline BRCA1/2 mutations.1 Identifying your patients with germline BRCA1/2 mutations is the first step to offering this new targeted therapy in your practice.

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All Patients with Pancreatic Cancer Should Receive Germline BRCA1/2 Testing at Diagnosis

According to the NCCN Guidelines®, patients with pancreatic cancer should have genetic risk evaluation and BRCA 1/2 testing.2

No family history is needed for patients with pancreatic cancer to meet genetic testing guidelines.

Testing at diagnosis may identify patients who are eligible for olaparib maintenance treatment following first-line platinum-based chemotherapy.

Confidently Determine BRCA1/2 Status in One-week or Less for Pancreatic Patients

BRACAnalysis CDx was designed and FDA-approved to quickly provide accurate germline BRCA1/2 reports so you can confidently recommend the next treatment for your patient without delay.

BRACAnalysis CDx® has a priority option for patients with pancreatic cancer with a one-week turnaround time. Timing is critical to identify patients who are eligible for olaparib maintenance treatment following first-line platinum-based chemotherapy. Ordering BRACAnalysis CDx at diagnosis will provide you and your patients this critical information to determine if PARP inhibitor therapy is appropriate.

Accelerated Results for Patients with Pancreatic Cancer

1. Place blood sample and completed test request form in the BRACAnalysis CDx Test Kit.

2. Place the priority label for patients with pancreatic cancer on the outside of the FedEx package.

Once Myriad receives the sample, you will receive the results of the BRACAnalysis CDx test in one week or less on your MyriadPro account. Reports will also be shipped overnight.

Order Everything I Need for Accelerated Results

Explore Patient Information and Indications for FDA-Approved PARP Inhibitors

Sources:
  1. Golan et al. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Eng Jnl Med (2019).
  2. Referenced with permission from the NCCN: Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 3.2019. ©National Comprehensive Cancer Network, Inc. 2018.

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.