Date: 2014-12-03
Type of information: Opening of new premises
Compound: Tumor BRACAnalysis CDx laboratory
Company: Myriad Genetics (USA - UT)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: opening of a new laboratory
Action mechanism: Tumor BRACAnalysis CDx is acompanion diagnostic test for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor BRACAnalysis CDx has undergone significant analytic validation and has been shown to identify up to 50 percent more patients with cancer-causing BRCA1/BRCA2 mutations compared to germline testing alone. Myriad is actively collaborating with leading pharmaceutical companies to develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents. In the United States, the testing will be done at the Company\'s laboratory in Salt Lake City. In Europe, the test will be performed at the Company\'s laboratory in Munich.
Disease: BRCA cancers, ovarian cancer
Details: * On October 24, 2014, Myriad Genetics announced it has established a Tumor BRACAnalysis CDx laboratory in Germany. Myriad\'s next-generation Tumor BRACAnalysis CDx test is a companion diagnostic that will identify up to 50 percent more patients with BRAC mutations who may benefit from treatment with PARP inhibitors, such as olaparib, compared to conventional germline testing alone. Up to 50 percent additional BRCA-deficient tumors detected to more accurately identify patients who are candidates for therapy with olaparib. Last month at the European Society for Medical Oncology (ESMO) annual meeting in Madrid, Spain, Myriad presented a study analyzing approximately 130 previously untreated, high-grade ovarian cancer patients for germline BRCA mutations in blood samples and somatic mutations in tissue samples. In the study, the researchers also tested patients undergoing surgery for both of these types of mutations. Of 92 patients who were tested for both germline and somatic markers, nearly 20 percent of patients were found to have germline mutations through a blood test. Meanwhile, testing with the Tumor BRACAnalysis CDx test identified all 20 percent of patients with germline mutations and an additional eight percent of patients with a somatic BRCA1/BRCA2 mutation, representing a 44 percent increase in the number of mutations identified.
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