Myriad Announces Four Poster Presentations at the 2016 European Society for Medical Oncology (ESMO) Annual Meeting
SALT LAKE CITY, Oct. 07, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that four poster presentations will be featured at the 2016 European Society for Medical Oncology (ESMO) annual meeting, October 7-11, 2016 in Copenhagen, Denmark.
"Myriad is a pioneer in personalized medicine and is committed to improving the prevention, detection and treatment of cancer," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "We are excited to present these new studies at ESMO that highlight and advance the science of our next-generation companion diagnostics to help inform and improve the treatment of cancer patients."
Please visit the Myriad booth #408 at ESMO for more information. Abstracts are available online at: http://www.esmo.org/Conferences/ESMO-2016-Congress/Abstracts. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.
Title: Outcomes of clinical testing for tumor BRCA1 and BRCA2 gene analysis for 354 patients: First experience with tumor companion diagnostic for PARP inhibitors.
Presenter: Karen Copeland, M.S.
Date: Saturday, Oct. 8, 2016. 1:00-2:00 p.m.
Location: Poster 874P (Abstract 4031). Hall E.
This study assessed 354 patients with ovarian cancer undergoing BRCA1 and BRCA2 full sequencing and large rearrangement DNA analysis using the Tumor BRACAnalysis CDx® test. The results show that, of the 354 samples analyzed, 93 (26.3 percent) tested positive for a pathogenic mutation; 57 were found in BRCA1 and 37 in BRCA2. Of the pathogenic mutations detected, 93.6 percent were sequencing variants and 6.4 percent were large rearrangements. These findings highlight the utility of the Tumor BRACAnalysis CDx test to accurately detect BRCA mutations in patients with ovarian cancer.
Title: The molecular landscape of genome instability in prostate cancer.
Presenter: Kirsten Timms, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 115P (Abstract 3247). Hall E.
In this study, DNA from 95 prostate cancer (PC) tumors was analyzed to generate homologous recombination deficiency (HRD) and Microsatellite instability (MSI) and cell cycle progression (CCP) scores. Additionally, 45 DNA damage repair (DDR) genes were sequenced and were considered non-functional if both alleles were mutated and/or deleted. If the second allele was intact, these genes were considered defective but functional. The results showed that non-functional DDR genes (CDK12, PALB2, RPA1, ATM, and BRCA2) were observed in seven tumors and DDR gene defects in eight genes were observed in 11 tumors. Importantly, the HRD score was significantly associated with DDR mutation status, Gleason score and CCP score. A significant proportion of aggressive prostate tumors carry molecular signatures associated with response to therapies targeting DDR deficiencies or to immune-therapeutics. This study demonstrates the importance of assessing both alleles when identifying prostate tumors with DDR gene mutations. In the study, an HRD score of ≥20 identified three times as many potential responders to HRD-dependent therapies compared to non-functional DDR gene mutations.
Title: Characteristics of homologous recombination deficiency (HRD) in paired primary and recurrent high-grade serous ovarian cancer.
Presenter: Jai Patel.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 113P (Abstract 3290). Hall E.
In this study, the myChoice® HRD test was used to evaluate paired primary and recurrent tumors from 54 patients with high-grade serous ovarian cancer (HGSOC), the vast majority of whom were treated with adjuvant carboplatin and paclitaxel. The objective was to determine if changes in the genomic profile of primary and recurrent tumors might impact the myChoice HRD score. The results showed that there were no significant differences in the genomic markers evaluated between primary and recurrent tumors. Importantly, the myChoice HRD test was not impacted by changes in the genomic profile. This finding suggests that testing recurrent HGSOC tumors would not alter treatment strategies relative to analysis of the primary tumor.
Title: Homologous recombination deficiency (HRD) score shows superior association with outcome compared to its individual score components (LOH, TAI, and LST scores) in platinum treated serous ovarian cancer.
Presenter: Jerry Lanchbury, Ph.D.
Date: Monday, Oct. 10, 2016. 1:00-2:00 p.m.
Location: Poster 112P (Abstract 2504). Hall E.
The myChoice HRD score is the sum of three independent measures of HRD, including loss of heterozygosity (LOH), telomeric-allelic imbalance (TAI) and large-scale state transitions (LST). This study compared the myChoice HRD score to its individual score components (LOH, TAI, and LST). The results showed that the myChoice HRD score is a superior prognostic marker of HR deficiency than the individual scores. There were a significant number of discrepancies between the myChoice HRD score and the individual component, which demonstrated a risk of both false positives and negatives. These findings support the use of myChoice HRD, rather than the individual biomarkers, to inform treatment decisions for patients.
About Tumor BRACAnalysis CDx®
Tumor BRACAnalysis CDx is a companion diagnostic test for identifying both germline and somatic cancer-causing mutations in the BRCA1 and BRCA2 genes. Currently, 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. Additionally, 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.
About myChoice® HRD
Myriad's myChoice HRD is the most comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD score is a composite of three proprietary technologies: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions. Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the presentation of data from four clinical studies at the 2016 European Society for Medical Oncology annual meeting to be held Oct 7-11, 2016 in Copenhagen, Denmark; key poster presentations highlighting the myChoice HRD and Tumor BRACAnalysis companion diagnostic tests; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers' reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2016, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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