Myriad Genetics' (MYGN) myChoice Gets Additional Reimbursement
Myriad Genetics, Inc. MYGN recently announced the receipt of additional reimbursement in Japan for its myChoice Diagnostic System. Notably, the test aids in identifying patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib).
For investors’ note, the myChoice companion diagnostic (CDx) test was approved by Japan’s Ministry of Health, Labour and Welfare, as a CDx test for this indication in November 2020. This reimbursement for use in first-line treatment is in addition to the already existing reimbursement for fourth-line treatment in ovarian cancer.
Notably, the primary aim of first-line treatment in patients with advanced ovarian cancer is to delay progression of the disease for as long as possible and maintain the patient’s quality of life. Further, the latest recommendations, based on clinical trial results, have been published in the Journal of Clinical Oncology.
The receipt of the recent favorable reimbursement is expected to significantly strengthen Myriad Genetics’ Molecular Diagnostic Testing business on a global scale.
Significance of the Reimbursement
Per estimates provided by the World Cancer Research Fund, ovarian cancer is the eighth most commonly occurring cancer in women. Further, most women are diagnosed at a much later stage or at an advanced stage of the cancer, having a five-year survival rate of around 30%, per the Ovarian Cancer Research Alliance.
The myChoice test is a comprehensive tumor test to determine homologous recombination deficiency (“HRD”) status resulting from mutations in genes such as BRCAm (BRCA1 and BRCA2). The test is capable of identifying patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib), as well as patients whose tumors are HRD-positive.
Further, the myChoice CDx test can be used in the identification of patients with tumors that have lost the ability to repair double-stranded DNA breaks. The loss in ability leads to greater susceptibility to DNA-damaging drugs such as PARP inhibitors commonly used in cancer treatment.
Industry Prospects
Per a report by Grand View Research, the global cancer diagnostics market was valued at $144.4 billion in 2018 and is expected to register a CAGR of 7% between 2019 and 2026. Factors like growing prevalence of oncologic cases, technological advancements and rising demand for effective screening tests are expected to boost the market.
Given the market potential, the recent favorable reimbursement is expected to boost Myriad Genetics business worldwide.
Recent Developments in Molecular Diagnostics
Of late, Myriad Genetics has been witnessing a slew of developments in its business.
The company, this month, entered into a new strategic collaboration in the precision oncology space with Intermountain Precision Genomics, a service of Intermountain Healthcare. This partnership will bring together Myriad Genetics’ hereditary cancer and CDx tests with Intermountain Precision Genomics’ laboratory services, utilizing the TheraMap test.
Myriad Genetics’ myChoice CDx testing revenues registered a solid year-over-year growth during the fiscal 2021 second quarter.
In February, Myriad Genetics announced additional data which further validates the prognostic power of its Prolaris test and its ability to help accurately predict which patients with more aggressive prostate cancer will benefit from intensification of therapy and who may safely avoid such treatments.
Again, in February, the company came out with a favorable outcome regarding its GeneSight Psychotropic test, demonstrating that the combinatorial approach available in the test is better than single-gene testing for predicting patient outcomes and medication blood levels.
Comparison With Peers
Myriad Genetics’ peer, Exact Sciences Corporation EXAS, announced its entry into an agreement to acquire Ashion Analytics, LLC from The Translational Genomics Research Institute, an affiliate of City of Hope, in February 2020. Per Myriad Genetics’ management, this buyout will aid in accelerating the development of its oncology portfolio (including minimum residual disease and other sequencing-based tests).
Another key player in the oncology space is Laboratory Corporation of America Holdings LH or LabCorp, currently focusing on strengthening its foothold in said space. During its fourth-quarter 2020 earnings call in February, the company confirmed the launch of a new non-invasive liquid biopsy test using next-generation sequencing for patients with non-small-cell lung cancer.
QIAGEN N.V. QGEN, a renowned name in the provision of Oncology Diagnostic Solutions, entered into a strategic collaboration with BioNTech SE in November 2020 with the aim of developing and commercializing a tissue-based therascreen test as a CDx. This assay, which will be used with investigational cancer treatment BNT113, will identify patients with squamous cell carcinoma of the head and neck that are caused by specific infections by human papilloma virus.
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