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2015-09-24

Myriad Genetics, Inc.: Myriad Genetics Presents New Data on Its Companion Diagnostic and Prostate Cancer Tests at the European Society for Medical Oncology Ann

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| SALT LAKE CITY, Sept. 24, 2015 (GLOBE NEWSWIRE) --Myriad Genetics, Inc. |
|(NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, |
|today announced three poster presentations that will be featured at the 40th |
|European Society for Medical Oncology (ESMO) meeting being held Sept. 25 to |
|29, 2015 in Vienna, Austria. The presentations include new studies on the |
|myChoice(TM) HRD and Tumor BRACAnalysis CDx(TM) companion diagnostic tests |
|and final results from the EMPATHY-P clinical utility study on Prolaris®. |
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|"Myriad continues to place a strong emphasis on molecular diagnostic research |
|with the goal of enabling personalized medicine and improving patient |
|outcomes. We are presenting exciting new data on the unique ability of our |
|companion diagnostics to identify the highest number of patients who may |
|benefit from drugs that target the DNA-repair pathway, such as PARP |
|inhibitors," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad. |
|"We're also presenting the final results for the EMPATHY-P study that show |
|the Prolaris test provides essential clinical information to help physicians |
|select men with prostate cancer who are good candidates for active |
|surveillance versus those who need more medical treatment based on a genetic |
|evaluation of their tumor." |
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|The list of key Myriad presentations at ESMO (#ECC2O15) follows. |
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|myChoice |
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|(TM) |
|HRD |
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|Title: DNA Repair Deficiencies in Ovarian Cancer: Genomic Analysis of High |
|Grade Serous Ovarian Tumors from the NOVA Study. |
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|Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST. |
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|Location: Hall C, Poster P108. |
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|Homologous recombination deficiency was assessed on tumors obtained from 318 |
|patients enrolled in the NOVA study, a Phase 3 clinical trial evaluating the |
|PARP inhibitor niraparib as a treatment in patients with platinum-sensitive |
|ovarian cancer. The results show that 100 percent of patients with a |
|germlineBRCA |
|mutation and 55 percent of patients without aBRCA |
|mutation were HRD positive as determined by the myChoice HRD test. |
|Importantly, the myChoice HRD test, which uses three novel algorithms of DNA |
|damage (LOH, LST, TAI), more clearly defined the HRD positive population in |
|ovarian cancer than did LOH alone. These findings support the use of the |
|myChoice HRD test to more effectively identify patients who may benefit from |
|therapy with DNA-damaging agents, such as platinum drugs and PARP inhibitors. |
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|Tumor BRACAnalysis CDx |
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|(TM) |
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|Title: Next Generation Sequencing of BRAC1 and BRCA2 Genes in Ovarian Tumors |
|Captures Germline Mutations and Expands the Potential Treatment Group for the |
|PARP Inhibitor Olaparib. |
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|Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST. |
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|Location: Hall C, Poster P116. |
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|This study assessed the ability of Tumor BRACAnalysis CDx, a tumor-based next |
|generation sequencing (NGS) test, to detect germlineBRAC1/2 |
|mutations in patients with high-grade serous ovarian cancer versus germline |
|testing using Sanger sequencing in a reference laboratory. Tumor tissue was |
|available from 54 patients to evaluate the Tumor BRACAnalysis CDx test. In |
|all 54 cases, Tumor BRACAnalysis CDx correctly identified the |
|deleteriousBRAC1/2 |
|mutations, demonstrating 100 percent sensitivity. The study also showed that |
|tumor cells havede novo |
|somatic mutations not identifiable via germline testing alone. For example, |
|Tumor BRACAnalysis CDx found 12 somaticBRCA1/2 |
|mutations, which represents an increase of 22 percent over germline testing in |
|a sample set that had been specifically enriched for germline mutations. |
|Importantly, patients with germline and tumorBRAC1/2 |
|mutations showed similar treatment response to olaparib, suggesting that tumor |
|testing effectively identifies patients appropriate for treatment with PARP |
|inhibitors. |
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|Prolaris® |
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|Title: Potential Reduction of Overtreatment of Localized Prostate Cancer Using |
|a Cell Cycle Gene Expression Assay (Prolaris) in Biopsy Specimens: Results |
|from the European Multi-Center EMPATHY-P Study. |
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|Date: Monday, Sept. 28, 2015: 4:45 to 6:45 p.m. CEST. |
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|Location: Hall C, Poster P072. |
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|The EMPATHY-P study evaluated the Prolaris test in 502 patient biopsy samples |
|to determine the aggressiveness of prostate cancer in these newly diagnosed |
|patients from five European countries including: Italy, Germany, Spain, |
|Switzerland and the UK. The patients' biopsy samples also were evaluated |
|using standard clinical pathology methods (D'Amico/AUA risk stratification) |
|that were then compared to the Prolaris test results. The EMPATHY-P data show |
|that overall the Prolaris test identified 54 percent of the European men with |
|a risk profile that was different than would be expected using standard |
|clinical pathology. Specifically, the EMPATHY-P study demonstrated that the |
|Prolaris test score found 24...

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