Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)
Posted: April 7, 2014 at 4:49 am
(Nasdaq:MYGN) today announced that it has submitted thefirst module of a premarket approval (PMA) application to the Food and DrugAdministration (FDA) for the use of BRACAnalysis(r) testing as a companiondiagnostic with olaparib. Olaparib is an investigational, orally activepoly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca. 'We believe an FDA-approved BRACAnalysis test will provide additional assurancethat patients are receiving the most accurate test results and improve patientcare by identifying candidates for treatment with olaparib,' said Mark Capone,president of Myriad Genetics Laboratories. 'Our PMA application forBRACAnalysis will provide the FDA with scientific data to evaluate the safetyand effectiveness of BRACAnalysis as a companion diagnostic.' Consistent with the FDA's modular premarket approval process, Myriad submittedthe first of four PMA modules and is working to submit the remaining modulesaccording to a pre-specified plan. The modular approach allows FDA to revieweach module as it is received and provides Myriad with timely feedback from FDAin order to help resolve issues early in the review process. 'Our PMA submission is a milestone for Myriad and BRACAnalysis is one of thefirst laboratory developed tests submitted for FDA premarket approval,' saidCapone. 'Our ability to navigate the regulatory process is benefitted by ourextensive experience in testing 1.2 million patients and our commitment to highquality.' The collaboration between Myriad and AstraZeneca on olaparib began in 2007.Since then, the two companies have shared scientific insight and worked closelytogether to move cancer research forward. In 2012, Myriad made strides indeveloping BRACAnalysis as a companion diagnostic by retrospectively genotypingpatients in a previously completed Phase 2 study of olaparib. This is apowerful example of how a companion diagnostic can advance the goals ofpersonalized medicine by stratifying patients in a clinical trial. About Myriad GeneticsMyriad Genetics is a leading molecular diagnostic company dedicated to making adifference in patients' lives through the discovery and commercialization oftransformative tests to assess a person's risk of developing disease, guidetreatment decisions and assess risk of disease progression and recurrence.Myriad's molecular diagnostic tests are based on an understanding of the rolegenes play in human disease and were developed with a commitment to improvingan individual's decision-making process for monitoring and treating disease.Myriad is focused on strategic directives to introduce new products, includingcompanion diagnostics, as well as expanding internationally. For moreinformation on how Myriad is making a difference, please visit the Company'swebsite: http://www.myriad.com. Myriad, the Myriad logo and Prolaris, Myriad myPath, Myriad myPlan, MyriadmyRisk, are trademarks or registered trademarks of Myriad Genetics, Inc. in theUnited States and foreign countries. MYGN-F, MYGN-G. Safe Harbor StatementThis press release contains 'forward-looking statements' within the meaning ofthe Private Securities Litigation Reform Act of 1995, including statementsrelating to an FDA-approved BRACAnalysis test providing additional assurancethat patients are receiving the most accurate test results and improvingpatient care by identifying candidates for treatment with olaparib; theCompany's PMA application for BRACAnalysis providing the FDA with scientificdata to evaluate the safety and effectiveness of BRACAnalysis as a companiondiagnostic; and the Company's strategic directives under the caption 'AboutMyriad Genetics.' These 'forward-looking statements' are management's presentexpectations of future events and are subject to a number of risks anduncertainties that could cause actual results to differ materially andadversely from those described in the forward-looking statements. These risksinclude, but are not limited to: the risk that sales and profit margins of ourexisting molecular diagnostic tests and companion diagnostic services maydecline or will not continue to increase at historical rates; risks related tochanges in the governmental or private insurers reimbursement levels for ourtests; the risk that we may be unable to develop or achieve commercial successfor additional molecular diagnostic tests and companion diagnostic services ina timely manner, or at all; the risk that we may not successfully develop newmarkets for our molecular diagnostic tests and companion diagnostic services,including our ability to successfully generate revenue outside the UnitedStates; the risk that licenses to the technology underlying our moleculardiagnostic tests and companion diagnostic services tests and any future testsare terminated or cannot be maintained on satisfactory terms; risks related todelays or other problems with opeRating our laboratory testing facilities;risks related to public concern over our genetic testing in general or ourtests in particular; risks related to regulatory requirements or enforcement inthe United States and foreign countries and changes in the structure of thehealthcare system or healthcare payment systems; risks related to our abilityto obtain new corporate collaborations or licenses and acquire new technologiesor businesses on satisfactory terms, if at all; risks related to our ability tosuccessfully integrate and derive benefits from any technologies or businessesthat we license or acquire; risks related to increased competition and thedevelopment of new competing tests and services; the risk that we or ourlicensors may be unable to protect or that third parties will infringe theproprietary technologies underlying our tests; the risk of patent-infringementclaims or challenges to the validity of our patents; risks related to changesin intellectual property laws covering our molecular diagnostic tests andcompanion diagnostic services and patents or enforcement in the United Statesand foreign countries, such as the Supreme Court decision in the lawsuitbrought against us by the Association for Molecular Pathology et al; risks ofnew, changing and competitive technologies and regulations in the United Statesand internationally; and other factors discussed under the heading 'RiskFactors' contained in Item 1A of our most recent Annual Report on Form 10-Kfiled with the Securities and Exchange Commission, as well as any updates tothose risk factors filed from time to time in our Quarterly Reports on Form10-Q or Current Reports on Form 8-K. All information in this press release isas of the date of the release, and Myriad undertakes no duty to update thisinformation unless required by law. CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.comNews Source: NASDAQ OMXEnd of Corporate News---------------------------------07.04.2014 Dissemination of a Corporate News, transmitted by DGAP - acompany of EQS Group AG.The issuer is solely responsible for the content of this announcement.DGAP's Distribution Services include Regulatory Announcements,Financial/Corporate News and Press Releases.Media archive at http://www.dgap-medientreff.de and http://www.dgap.de---------------------------------Language: English Company: Myriad Genetics, Inc. United States ISIN: US62855J1043 End of News DGAP News-Service --------------------------------- 261855 07.04.2014
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Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)