On January 8, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, which helps determine if women with ovarian cancer will benefit from the PARP inhibitor, Zejula (niraparib) (Press release, Myriad Genetics, JAN 8, 2021, View Source [SID1234573707]). myChoice was approved by Japan’s Ministry of Health, Labour and Welfare in September 2020 as a companion diagnostic for this indication and the reimbursement decision is now in effect.
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"Myriad’s myChoice test is the only one of its kind to be approved for reimbursement in Japan," said Nicole Lambert, president of Myriad Genetic Laboratories. "This decision further advances precision medicine and helps ensure that more Japanese women have access to the most advanced therapies in their fight against ovarian cancer."
Myriad has been collaborating with Takeda Pharmaceutical Company in Japan since 2017 on the development of companion diagnostics to extend the benefit of the newest and most innovative treatments to more patients. Takeda is the largest pharmaceutical company in Asia and one of the top 10 largest pharmaceutical companies in the world by revenue.
"This most recent approval enables physicians to have the best options available to effectively treat women with ovarian cancer," said Professor Daisuke Aoki, M.D., Ph.D., Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. "Physicians can immediately use Myriad myChoice to identify patients that could potentially benefit from treatment with Zejula."
In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.
Myriad has partnered with SRL Inc., a subsidiary of the H.U. Group Holdings, Inc., to commercialize the myChoice Diagnostic System in Japan.
About SRL
Since the establishment in 1970, SRL, Inc., a member of the H.U. Group Holdings, Inc., Japan-based leading healthcare group, has been providing comprehensive testing services as the largest commercial clinical laboratory in Japan. SRL carries out nearly 400,000,000 tests per year, covering a wide range of testing services including general/emergency testing, esoteric/research testing, companion diagnostics tests, genomic analysis, and etc. For more information, please visit View Source
About the myChoice Diagnostic System
Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have 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 test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: View Source
Zejula (niraparib) is a licensed product from GSK (formerly TESARO. Inc).