Myriad’s chief scientific officer, Dale Muzzey, highlighted that breast cancer often presents low ctDNA levels, compared to other cancer types, making MRD testing challenging. Image credit: Daniel L. Locke / Shutterstock.

Myriad Genetics has announced five research collaborations with health institutions to study the use of its Precise MRD test in molecular residual disease (MRD) testing applications in breast cancer management.

The studies will evaluate the use of circulating tumour DNA (ctDNA) in monitoring treatment response in breast cancer patients. The Precise MRD test is a genome sequencing (WGS) based test that monitors tumour-specific variants and enables quantification of ctDNA.

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Earlier this year, the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) voted in favour of supporting the use of MRD as a surrogate endpoint to enable accelerated approvals of new therapies in multiple myeloma. This has led to an increased awareness in using MRD testing in other cancer types along with an interest in developing MRD tests for different cancer types.

One of the collaborations is with the University of Texas MD Anderson Cancer Center. The study aims to determine whether ctDNA may be used to predict the treatment response to Merck & Co’s Keytruda (pembrolizumab) and hormonal therapy in patients with HR-positive inflammatory breast cancer who did not achieve pathological complete response at the time of surgery.

The second US collaboration with the University of Rochester Medical Center aims to use the Precise MRD test to potentially inform surgical decision-making. The study will also evaluate whether ctDNA levels correlate with nodal involvement in patients with newly diagnosed HR-positive breast cancer.

Myriad has also partnered with MONITOR-breast study, a prospective trial that is aimed at determining the association of ctDNA levels to both neoadjuvant and adjuvant therapy in patients with newly diagnosed breast cancer across all subtypes. The study is expected to enrol 650 patients and will assess the prognostic potential of ctDNA and determine if ctDNA can enable earlier detection of recurrence compared to standard imaging techniques.

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The company also has an international partnership with Japan’s National Cancer Center Hospital East. Precise MRD test will be used in the prospective study JBCRG-C11 (CREA) trial (jRCT1031240010) to evaluate the maintenance of complete response with AstraZeneca and Daiichi Sankyo’s Enhrtu (trastuzumab deruxtecan) in HER2-positive advanced or metastatic breast cancer patients. The study will also evaluate whether ctDNA can be used to guide therapy optimisation.

Myriad’s fifth partnership is with US and Europe-based healthcare consulting firm Aptitude Health to assess ctDNA levels in high-risk patients in community oncology settings. The study will evaluate ctDNA levels during different treatment stages – at diagnosis, during neoadjuvant treatment, and following surgery.