Myriad Obtains CE Mark for Tumor BRACAnalysis CDx(TM) and Launches Test in Europe as Companion Diagnostic for PARP Inhibitors
SALT LAKE CITY and ZURICH, Jan. 8, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced the Company has obtained CE Marking in Europe for its Tumor BRACAnalysis CDx test, which identifies tumors that have mutations in the BRCA1 or BRCA2 genes. Tumor BRACAnalysis CDx is the first and only tumor-based companion diagnostic that is CE-marked and can identify patients that would be appropriate for Lynparza, a poly ADP-ribose polymerase (PARP) inhibitor.
“Obtaining a CE Marking for Tumor BRACAnalysis CDx is a significant milestone and achievement for the Myriad team. The CE Mark allows us to offer a validated tumor-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe,” said Gary King, executive vice president, International Operations, Myriad. “We are actively engaged in strategic activities with thought leaders and cancer centers to ensure a successful launch in Europe.”
Last month, the European Medicines Agency’s (EMA) approved Lynparza as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. It is estimated that more than 28 percent of ovarian cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from Lynparza therapy. In clinical studies conducted by Myriad, the Tumor BRACAnalysis CDx test identified up to 44 percent more cancer patients with BRCA mutations who are candidates for treatment with PARP inhibitors, compared to conventional germline BRCA testing alone.
“The trend in modern medicine is toward tailored therapy that will give patients the best chance for successful outcomes. In ovarian cancer, it is critical to identify which patients have somatic or germline BRCA mutations and may benefit from the new class of PARP inhibitors,” said Colin Hayward, M.D., European medical director, Myriad. “Tumor BRACAnalysis CDx is the most effective method for screening patients since it detects both germline and somatic BRCA mutations. It provides physicians with confidence that they will identify the greatest number of patients who are candidates for this new breakthrough class of drugs.”
Myriad Genetics GmbH offers Tumor BRACAnalysis CDx throughout Europe performed at its laboratories in Munich, Germany. The test has an average 14-day laboratory turnaround time, which is essential for timely treatment decision-making by physicians and patients For more information, please call Myriad Genetics GmbH at: +41 44 939 91 44 or visit: http://www.myriadgenetics.eu.
About Tumor BRACAnalysis CDx™
Myriad’s Tumor BRACAnalysis CDx is the most robust and accurate companion 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 44 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 novel chemotherapeutic agents.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad is focused on strategic directives to grow our markets, introduce new products, including companion diagnostics, as well as to expand internationally. For more information on how Myriad is making a difference, please visit the Company’s websites: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, Tumor BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G
About Myriad Genetics GmbH
Myriad Genetics GmbH is based in Zurich, Switzerland and is the international subsidiary of Myriad Genetics Inc., a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. For more information on how Myriad Genetics GmbH is making a difference, please visit the Company’s European website: www.myriadgenetics.eu.
Notes to Editors
*Lynparza is a trademark of AstraZeneca PLC.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the launch of Tumor BRACAnalysis CDx in Europe; offering Tumor BRACAnalysis CDx as a validated tumor-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe; Tumor BRACAnalysis CDx being the most effective method for screening patients by detecting both germline and somatic BRCA mutations; providing the Tumor BRACAnalysis CDx test at the Company’s laboratory facilities in Munich, Germany; and the Company’s statements under the captions “About Tumor BRACAnalysis CDx,” “About Myriad Genetics” and “About Myriad Genetics GmbH.” 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 existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to changes in the 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; 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 we may not be successful in transitioning from our existing product portfolio to our new products, such as our myRisk Hereditary Cancer test, which represents the next generation of our existing hereditary cancer franchise; the risk that we may not be able to generate sufficient revenue from our existing tests and our new tests or develop new tests; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 increased competition and the development of new competing tests and services; risks related to our projections about the potential market opportunity for our products; 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; 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 in our most recent Annual Report on Form 10-K 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.
CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
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