title: BRACAnalysis CDx as a companion diagnostic tool for Lynparza.
abstract: Lynparza and its companion diagnostic test, BRACAnalysis were approved by the US FDA in December 2014 for recurrent ovarian cancer in women with a germline BRCA mutation. Women with a deleterious BRCA mutation are predisposed to ovarian cancer due to deficient homologous recombination repair. Inhibition of the PARP enzyme forces use of an alternate error-prone pathway for repair; PARP trapping is another mechanism utilized that blocks cellular replication by trapping inactivated PARP onto single-stranded DNA breaks. Although many companion diagnostic kits are already in use in oncology, BRACAnaylsis is unique in several ways including comprehensive BRCA gene germline profiling, availability to all women with ovarian cancer and implications for family members.
authors: a University of Oklahoma Health Sciences Center, Stephenson Cancer Center, Division of Gynecologic Oncology, 800 NE 10th Street, Suite 5040, Oklahoma City, OK 73104, USA.
authors: Camille C
authors: CC
authors: Gunderson
authors: Kathleen N
authors: KN
authors: Moore
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D005820:Genetic Testing / Q000191:economics / Q000379:methods*; D018095:Germ-Line Mutation; D006801:Humans; D058990:Molecular Targeted Therapy; D010051:Ovarian Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics* / Q000378:metabolism; D010793:Phthalazines / Q000627:therapeutic use; D010879:Piperazines / Q000627:therapeutic use; D000067856:Poly(ADP-ribose) Polymerase Inhibitors / Q000627:therapeutic use; D011065:Poly(ADP-ribose) Polymerases / Q000378:metabolism
chemical_list: D000970:Antineoplastic Agents; D010793:Phthalazines; D010879:Piperazines; D000067856:Poly(ADP-ribose) Polymerase Inhibitors; D011065:Poly(ADP-ribose) Polymerases; C531550:olaparib
keywords: BRCA mutation; Lynparza; PARP inhibitor; companion diagnostic; hereditary; ovarian cancer