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FDA-approved companion diagnostic

BRACAnalysis CDx

PCR- and Sanger-based germline BRCA1/2 companion diagnostic that detects pathogenic variants in blood to help guide use of PARP inhibitors and other targeted therapies.

Lab-developed CDxMethod: PCRSpecimen: Whole bloodBiomarker: BRCA1, BRCA2
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P140020
Supplements
S012, S015, S016, S019, S020
Manufacturer
Myriad Genetics
Approval date
December 19, 2014
Test specifications
Methodology
PCR
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
BRCA1, BRCA2
What this test is

BRACAnalysis CDx is an FDA-approved, blood-based germline BRCA1/2 assay that uses PCR, Sanger sequencing, and multiplex PCR to detect single-nucleotide variants, small indels, and large rearrangements in BRCA1 and BRCA2. Results classify variants as deleterious or suspected deleterious to help identify patients with BRCA-associated cancers who may be candidates for BRCA-directed targeted therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Breast CancerBRCA1 and BRCA2alterations (including mutations)LYNPARZA, TALZENNA
Metastatic Castrate Resistant Prostate Cancer (mCRPC)BRCA1 and BRCA2alterations (including mutations)LYNPARZA
Ovarian CancerBRCA1 and BRCA2alterations (including mutations)LYNPARZA, RUBRACA
Pancreatic CancerBRCA1 and BRCA2alterations (including mutations)LYNPARZA

Performing lab

Myriad Genetics

Myriad Genetic Laboratories – Myriad West (46D2275645)

Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Order this test

If your organization is connected to Casandra, you can place an electronic order forBRACAnalysis CDx directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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