Tumor BRACAnalysis CDx : companion diagnostic tumor testing for mutations in the BRCA1 and BRCA2 genes
What is Tumor BRACAnalysis CDx?
Companion diagnostics (CDx) are tests developed to identify suitable patients for the safe and effective use of a corresponding therapeutic product.
Tumor BRACAnalysis CDx is a CE-marked genomic test designed to detect the presence of a BRCA1 or BRCA2 gene mutation in ovarian tumor tissue.
Why test for BRCA-mutations in the tumor?
Hereditary BRCA1 and BRCA2 mutations are commonly detected through testing of blood or saliva samples; these types of mutations are called germline mutations. Independent of any germline mutation, a tumor may have a de novo somatic mutation not identifiable through germline testing. Studies have shown that testing ovarian tumor tissue enables identification of tumors with germline or somatic mutations, and could identify up to 50% more patients with BRCA-mutated ovarian cancer compared to germline testing alone.
How can a Tumor BRACAnalysis result help guide patient management?
Knowing a patient has BRCA-mutated ovarian cancer, helps to establish:
- Their likelihood to benefit from select PARP (poly ADP-ribose polymerase) inhibitor therapy
- Their possibility of improved progression-free survival and overall survival
With the introduction of PARP inhibitors, BRCA mutation testing is critical in ovarian cancer patients to identify the subset of women who might benefit from this therapy choice. Testing the tumor rather than blood or saliva for the mutation:
- identifies more patients who carry a BRCA1 or BRCA2 mutation;
- helps more ovarian cancer patients, along with their healthcare professionals, understand their treatment options, and;
- increases the total number of patients who may benefit from innovative PARP inhibitor therapy.
The future of companion diagnostics
Myriad is a pioneer in the field of companion diagnostics. Tumor BRACAnalysis CDx is the most robust and accurate companion diagnostic test for identifying both germline and somatic cancer-causing mutations in the BRCA1 and BRCA2 genes. Myriad is actively collaborating with leading pharmaceutical companies and academic centers to further develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents.
NOTE: Any discussion of medical management options is for general informational purposes only and does not constitute a recommendation. While genetic testing and medical society guidelines provide important and useful information, medical management decisions should be made based on consultation between each patient and his or her healthcare professional.