Physician Guide
Test Kit

Testing to Treat Requires Faster Results

Fill out the form below to order everything you need to offer BRACAnalysis CDx at your practice

You will receive:
  • BRACAnalysis CDx Test Kit
  • BRACAnalysis CDx Physician Guide
  • Priority package labels for patients with pancreatic cancer
BRACAnalysis CDx Ordering Process
  • BRACAnalysis CDx can be ordered by sending a blood sample with the completed test request form in the BRACAnalysis CDx Test Kit to Myriad’s lab.
  • Once Myriad receives the sample, you will receive the results of the BRACAnalysis CDx test in two weeks or less (unless you are using accelerated results for pancreatic cancer)
  • You will receive BRACAnalysis CDx results quicker by signing up for a MyriadPro account. This will allow you to review reports online.

If you just need additional test kits for your practice but you aren’t a first-time tester, click here.

Order First Time BRACAnalysis CDx Test Kit

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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 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.