|Myriad Submits Premarket Approval to FDA for BRACAnalysis(R); FDA Extends PDUFA Date for MannKind'S AFREZZA|
|By Staff and Wire Reports|
|Monday, 07 April 2014 21:33|
Myriad Genetics (Nasdaq: MYGN) today announced that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis(R) testing as a companion diagnostic with olaparib.
Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca. "We believe an FDA-approved BRACAnalysis test will provide additional assurance that patients are receiving the most accurate test results and improve patient care by identifying candidates for treatment with olaparib," said Mark Capone, president of Myriad Genetics Laboratories. "Our PMA application for BRACAnalysis will provide the FDA with scientific data to evaluate the safety and effectiveness of BRACAnalysis as a companion diagnostic."
Consistent with the FDA's modular premarket approval process, Myriad submitted the first of four PMA modules and is working to submit the remaining modules according to a pre-specified plan. The modular approach allows FDA to review each module as it is received and provides Myriad with timely feedback from FDA in order to help resolve issues early in the review process. "Our PMA submission is a milestone for Myriad and BRACAnalysis is one of the first laboratory developed tests submitted for FDA premarket approval," said Capone. "Our ability to navigate the regulatory process is benefitted by our extensive experience in testing 1.2 million patients and our commitment to high quality."
The collaboration between Myriad and AstraZeneca on olaparib began in 2007. Since then, the two companies have shared scientific insight and worked closely together to move cancer research forward. In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib.
This is a powerful example of how a companion diagnostic can advance the goals of personalized medicine by stratifying patients in a clinical trial. 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's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision-making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally.
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Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has submitted the first module of a premarket approval (PMA) application to the Food and Drug Administration (FDA) for the use of BRACAnalysis® testing as a companion diagnostic with olaparib.
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