Myriad to Seek FDA Approval for BRACAnalysis as Companion Diagnostic
SALT LAKE CITY, UT, USA I June 1, 2013 I Myriad Genetics, Inc. (MYGN) today announced that AstraZeneca will use Myriad’s BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca’s pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States.
“We are pioneers in personalized medicine and believe the future of drug development is using companion diagnostics to identify responders and non-responders to therapy,” said Peter D. Meldrum, president and CEO of Myriad. “BRACAnalysis testing has shown significant potential as a companion diagnostic to select which patients will respond to PARP inhibitors, and we look forward to collaborating with AstraZeneca on the clinical program for olaparib.”
While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer(TM) for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic — following review by FDA — to help select patients who are likely to respond to poly ADP ribose polymerase (PARP) inhibitors, a novel, targeted class of promising cancer therapeutics.
Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
“Myriad has a proven track record with high-quality BRAC mutation testing for hereditary breast and ovarian cancer, and we are excited by the potential for BRACAnalysis to be useful as a companion diagnostic that will help clinicians to select cancer patients who are appropriate candidates for receiving olaparib,” said Ruth March, vice president and head of Personalised Healthcare and Biomarkers at AstraZeneca.
About BRACAnalysis(R)
BRACAnalysis is a genetic test that confirms the presence of a BRCA1 or BRCA2 gene mutation. BRCA mutations are responsible for the majority of hereditary breast and ovarian cancers. People with a mutation in either the BRCA1 or BRCA2 gene have risks of up to 87% for developing breast cancer and up to 44% for developing ovarian cancer by age 70. Mutation carriers previously diagnosed with cancer also have a significantly increased risk of developing a second primary cancer. Genetic testing, specifically the BRACAnalysis test, identifies patients who have these mutations.
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 portfolio of 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. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
SOURCE: Myriad Genetics
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Myriad to Seek FDA Approval for BRACAnalysis as Companion Diagnostic
SALT LAKE CITY, UT, USA I June 1, 2013 I Myriad Genetics, Inc. (MYGN) today announced that AstraZeneca will use Myriad’s BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca’s pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States.
“We are pioneers in personalized medicine and believe the future of drug development is using companion diagnostics to identify responders and non-responders to therapy,” said Peter D. Meldrum, president and CEO of Myriad. “BRACAnalysis testing has shown significant potential as a companion diagnostic to select which patients will respond to PARP inhibitors, and we look forward to collaborating with AstraZeneca on the clinical program for olaparib.”
While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer(TM) for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic — following review by FDA — to help select patients who are likely to respond to poly ADP ribose polymerase (PARP) inhibitors, a novel, targeted class of promising cancer therapeutics.
Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
“Myriad has a proven track record with high-quality BRAC mutation testing for hereditary breast and ovarian cancer, and we are excited by the potential for BRACAnalysis to be useful as a companion diagnostic that will help clinicians to select cancer patients who are appropriate candidates for receiving olaparib,” said Ruth March, vice president and head of Personalised Healthcare and Biomarkers at AstraZeneca.
About BRACAnalysis(R)
BRACAnalysis is a genetic test that confirms the presence of a BRCA1 or BRCA2 gene mutation. BRCA mutations are responsible for the majority of hereditary breast and ovarian cancers. People with a mutation in either the BRCA1 or BRCA2 gene have risks of up to 87% for developing breast cancer and up to 44% for developing ovarian cancer by age 70. Mutation carriers previously diagnosed with cancer also have a significantly increased risk of developing a second primary cancer. Genetic testing, specifically the BRACAnalysis test, identifies patients who have these mutations.
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 portfolio of 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. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
SOURCE: Myriad Genetics
Post Views: 100
