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The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer.
Approved 19 December 2014 (PMA P140020) as the companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer, the first FDA-approved companion diagnostic based on an inherited variant. Claims followed for olaparib and talazoparib in HER2-negative metastatic breast cancer (2018), olaparib maintenance in first-line ovarian cancer (SOLO-1, 2018), pancreatic cancer (POLO, 2019), metastatic castration-resistant prostate cancer (PROfound, 2020) and early breast cancer (OlympiA, 2022). Myriad's monopoly on BRCA testing ended with the 2013 US Supreme Court ruling that isolated genes cannot be patented, and multi-gene hereditary panels have since become the norm, but BRACAnalysis CDx remains the labelled test.
Sanger and NGS sequencing plus large-rearrangement analysis of germline BRCA1 and BRCA2 from blood, classifying variants as deleterious or suspected deleterious. Connects to BRCA1 / BRCA2 (HRD) and PARP.
1.BRACAnalysis CDx slips into a pocket on BRCA1 / BRCA2 (HRD).
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer |
| US | 2018 | Olaparib and talazoparib in germline BRCA-mutated HER2-negative metastatic breast cancer |
| US | 2019 | Olaparib maintenance in germline BRCA-mutated metastatic pancreatic cancer |
| US | 2020 | Olaparib in germline BRCA-mutated metastatic castration-resistant prostate cancer |
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Germline testing for every pancreatic cancer patient, platinum first line for BRCA carriers, and olaparib maintenance for those who respond are all downstream of POLO.
This cohort underpins the guideline shift to germline BRCA1/2 testing for all TNBC patients regardless of age or family history, and it is the prevalence figure the corpus uses for germline BRCA1 in TNBC.
Query for this drug: (TITLE:"BRACAnalysis CDx" OR ABSTRACT:"BRACAnalysis CDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about BRACAnalysis CDx, not a curated reading list.
Shares Myriad Genetics, HRD & BRCA testing, Companion diagnostics, PARP and the tag test.
Shares Germline vs somatic mutations, Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer, Pancreatic ductal adenocarcinoma and the tag test.
Shares Myriad Genetics, HR-positive / HER2-negative breast cancer and the tag test.
Shares Myriad Genetics, Prostate cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.