On March 24, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported that it has received additional reimbursement for its myChoice Diagnostic System in Japan (Press release, Myriad Genetics, MAR 24, 2021, View Source [SID1234577083]).
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The Myriad myChoice test is the most comprehensive tumor test for determining homologous recombination deficiency (HRD) status caused by a range of mutations in genes such as BRCA1 and BRCA2. It enables healthcare professionals to identify patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib). This capability benefits BRCAm patients – carriers of harmful mutations in either the BRCA1 or BRCA2 gene (BRCAm) – and patients whose tumors are HRD-positive. Japan’s Ministry of Health, Labour and Welfare approved myChoice as a companion diagnostic for this indication in November 2020, and in addition to the reimbursement for fourth-line treatment in ovarian cancer, reimbursement is now available for use in first-line treatment, as well.
According to the World Cancer Research Fund, ovarian cancer is the eighth most commonly occurring cancer in women. Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%, according to the Ovarian Cancer Research Alliance. For patients with advanced ovarian cancer, the primary aim of first-line treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life.
"This most recent approval enables physicians to have additional options available to effectively treat women with advanced ovarian cancer," said Professor Daisuke Aoki, M.D., Ph.D., Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. "Physicians can now use Myriad myChoice to identify patients that could potentially benefit from maintenance treatment with Lynparza."
The Myriad myChoice CDx test can be used to identify people with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as PARP inhibitors commonly used in cancer treatment. In August 2020, myChoice was exclusively cited by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in recommendations on the use of PARP inhibitors for the treatment and management of BRCAm and HRD-positive patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology. The myChoice test has also been used in the PAOLA-1 and SOLO-1 trials.
"The use of genetic testing and precision medicine is increasingly important when it comes to guiding treatment for women with advanced ovarian cancer," said Nicole Lambert, president of Myriad Genetic Laboratories. "The approval and now additional reimbursement of the myChoice test will empower healthcare professionals in Japan to better identify and treat patients who may respond to targeted therapy. Our work with AstraZeneca is another example of how strong collaboration among industry leaders can benefit patients and providers."
Myriad has been working with AstraZeneca since 2007 on the development of companion diagnostics for Lynparza. Lynparza is a trademark of AstraZeneca. Lynparza is jointly developed and commercialized by AstraZeneca and Merck (known as MSD Inc. outside the United States and Canada). Additionally, Myriad has partnered with SRL Inc., a subsidiary of H.U. Group Holdings, Inc. to expand the commercialization of the myChoice Diagnostic System in Japan.
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
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 other tests. For more information, please visit View Source