Myriad Genetics relies on strategic alliances to research MRD tests in breast cancer management

Myriad Genetics has initiated collaborations with five renowned healthcare institutions to investigate the application of its Precise MRD test in the field of molecular minimal residual disease (MRD) for the treatment of breast cancer. These studies will evaluate the use of circulating tumor DNA (ctDNA) to monitor therapy response in breast cancer patients. The Precise MRD test is based on genomic sequencing and enables the quantification of ctDNA by tracking tumor-specific variants. A significant development this year was the supportive vote of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. FDA to use MRD as a surrogate endpoint for accelerated approvals of new therapies for multiple myeloma. This has sparked interest in MRD tests for other cancer types as well and has driven the development of corresponding testing procedures. One of the partnerships is with the MD Anderson Cancer Center at the University of Texas. This study investigates whether ctDNA can be used to predict therapy response to Merck & Co.'s Keytruda and hormone therapy in patients with HR-positive inflammatory breast cancer who have not achieved a pathological complete remission post-surgery. Another U.S. project in collaboration with the University of Rochester Medical Center aims to assess the suitability of the Precise MRD test as a decision-making aid for surgical interventions. Additionally, the relationship between ctDNA levels and nodal involvement in newly diagnosed HR-positive breast cancer will be evaluated. Furthermore, Myriad is working on the MONITOR-breast study project, which includes a prospective investigation linking ctDNA levels with neoadjuvant and adjuvant therapy across all breast cancer subtypes. This involves 650 patients to analyze the prognostic power of ctDNA and evaluate whether ctDNA enables earlier detection of recurrences compared to conventional imaging techniques. Internationally, Myriad is collaborating with the National Cancer Center Hospital East in Japan. The Precise MRD test is being utilized in the JBCRG-C11 (CREA) study to verify the maintenance of complete remission in HER2-positive advanced or metastatic breast cancer patients under therapy with AstraZeneca and Daiichi Sankyo's Enhertu, and to use ctDNA to optimize therapy management. The fifth partnership, with the healthcare advisory specialist Aptitude Health, which operates in both the U.S. and Europe, analyzes ctDNA levels in high-risk patients in oncological community settings. This involves investigating ctDNA levels at various treatment stages – at diagnosis, during neoadjuvant treatment, and post-operation.