Myriad Genetics Announces Five Research Collaborations to Study the Use of MRD Testing in Breast Cancer

Rhea-AI Summary

Myriad Genetics (NASDAQ: MYGN) has announced five research collaborations to study the use of molecular residual disease (MRD) testing in breast cancer using their Precise® MRD test. These collaborations include:

• A study on ctDNA levels predicting response to therapy in HR-positive inflammatory breast cancer
• Research on ctDNA levels correlating with nodal involvement in HR-positive breast cancer
• The MONITOR-breast study assessing ctDNA levels in neoadjuvant and adjuvant therapy
• The JBCRG-C11 (CREA) study evaluating ctDNA for guiding therapy in HER2-positive breast cancer
• A study with Aptitude Health on ctDNA levels in high-risk patients in community oncology settings

Myriad's Precise MRD test tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing, making it suitable for detecting low levels of ctDNA in breast cancer.

Positive

• Myriad Genetics is expanding its research collaborations in breast cancer MRD testing
• The Precise® MRD test can track up to 1,000 tumor-specific variants, potentially improving detection in breast cancer
• Collaborations with leading organizations and investigators may advance clinical applications of MRD testing in breast cancer

Negative

• None.

Insights

Medical Research Analyst

This announcement of five research collaborations for Myriad Genetics' Precise® MRD test in breast cancer is a significant development in the field of personalized oncology. The studies aim to address critical questions about using circulating tumor DNA (ctDNA) for predicting treatment response, guiding surgical decisions and monitoring disease progression.

The collaborations with prestigious institutions like MD Anderson and multicenter prospective studies involving hundreds of patients underscore the potential impact of this technology. Particularly noteworthy is the focus on overcoming the challenge of low ctDNA levels in breast cancer, which has been a limiting factor in applying MRD testing to this common cancer type.

For investors, this news signals Myriad's commitment to expanding its precision medicine portfolio and potentially capturing a larger share of the growing MRD testing market. Success in these studies could lead to broader adoption of Precise® MRD in breast cancer management, potentially driving future revenue growth. However, it's important to note that these are research collaborations and commercial impact may take time to materialize pending study outcomes and regulatory approvals.

Oncology Expert

The breadth of these research collaborations is impressive, covering various aspects of breast cancer management where MRD testing could make a significant impact. The studies address key clinical questions:

• Predicting response to immunotherapy and hormonal therapy in inflammatory breast cancer
• Guiding surgical decisions based on nodal involvement
• Monitoring treatment response in neoadjuvant and adjuvant settings
• Optimizing therapy in HER2-positive advanced breast cancer
• Assessing MRD in community oncology settings

Myriad's approach of tracking up to 1,000 tumor-specific variants via whole-genome sequencing is particularly promising for breast cancer, where ctDNA levels are typically low. If successful, this could lead to earlier detection of recurrence and more personalized treatment strategies, potentially improving patient outcomes. The involvement of community oncology settings is also important for broader clinical adoption.

While these studies are promising, it's important to remember that translating research findings into clinical practice can take several years. The real-world utility and cost-effectiveness of MRD testing in breast cancer management will need to be clearly demonstrated before widespread adoption occurs.

SALT LAKE CITY, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced a series of ongoing research collaborations to study the use of molecular residual disease (MRD) testing in breast cancer using Myriad’s Precise^® MRD test.

Research collaborations include:

• A study to determine whether circulating tumor DNA (ctDNA) level may predict magnitude of response to pembrolizumab and hormonal therapy in patients with HR-positive inflammatory breast cancer who did not achieve pathological complete response at the time of surgery, led by Bora Lim, MD, at The University of Texas MD Anderson Cancer Center.
• A study to evaluate whether ctDNA levels correlate with nodal involvement in patients with newly diagnosed HR-positive breast cancer and, if so, how the correspondence may be used to aid in surgical decision making, led by Anna Weiss, MD, at The University of Rochester Medical Center.
• The multicenter, prospective MONITOR-breast study to determine the association of ctDNA levels to both neoadjuvant and adjuvant therapy in patients with newly diagnosed breast cancer across all subtypes. The study will involve 650 patients and will assess the prognostic potential of ctDNA and the lead time of detecting recurrence earlier ahead of standard-of-care imaging.
• The multicenter, prospective study JBCRG-C11 (CREA) to evaluate the maintenance of complete response with trastuzumab deruxtecan (T-DXd) in HER2-positive advanced or metastatic breast cancer patients and whether ctDNA can be used to optimally guide therapy, led by Yoichi Naito, MD, of the National Cancer Center Hospital East in Japan.
• A study in partnership with Aptitude Health to assess ctDNA levels in high-risk patients at diagnosis, during neoadjuvant treatment, and following surgery in community oncology settings.

“Relative to many other cancer types that typically have high levels of ctDNA in the blood, breast cancer often has very low levels of ctDNA, which makes MRD testing a challenge,” said Dale Muzzey, chief scientific officer, Myriad Genetics. “Myriad’s Precise MRD test is well suited to overcome this challenge because it tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing. The research efforts we’re undertaking with leading organizations and investigators are an important step in advancing the clinical application of next-generation MRD testing to the treatment and monitoring of breast cancer.”

Myriad continues to develop its Precise MRD test to meet the needs of cancer patients, academic partners, and biopharma companies. Myriad has previously announced other MRD collaborations, including a metastatic breast cancer study with researchers at Memorial Sloan Kettering Cancer Center and a prospective pan-cancer study, including breast cancer, led by researchers at the National Cancer Center Hospital East in Japan.

About Myriad’s Precise MRD Test
Myriad’s Precise MRD test is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants, which enables exceptional sensitivity and quantification of circulating tumor DNA (ctDNA) in the blood of patients with cancer. The Precise MRD test can be used to monitor ctDNA levels throughout a cancer patient’s clinical care, starting immediately after diagnosis and continuing through treatment and surveillance. The Precise MRD test is available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators.

About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Myriad Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including that the company's research collaborations, such as a study that will involve 650 patients and will assess the prognostic potential of ctDNA and the lead time of detecting recurrence ahead of standard-of-care imaging, represent an important step in advancing the clinical application of next-generation MRD testing to the treatment and monitoring of breast cancer and that the company’s Precise MRD test is well suited to overcome some of the challenges faced by MRD testing because it tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on February 28, 2024, as well as any updates to those risk factors filed from time to time in the company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.

Investor Contact
Matt Scalo
(801) 584-3532
IR@myriad.com

Media Contact
Glenn Farrell
(385) 318-3718
PR@myriad.com  

FAQ

What is the purpose of Myriad Genetics' new research collaborations for breast cancer?

The purpose is to study the use of molecular residual disease (MRD) testing in breast cancer using Myriad's Precise® MRD test, exploring its potential in various clinical scenarios and treatment decisions.

How many research collaborations did Myriad Genetics (MYGN) announce for breast cancer MRD testing?

Myriad Genetics announced five research collaborations to study the use of MRD testing in breast cancer using their Precise® MRD test.

What is the MONITOR-breast study announced by Myriad Genetics (MYGN)?

The MONITOR-breast study is a multicenter, prospective study involving 650 patients to determine the association of ctDNA levels to neoadjuvant and adjuvant therapy in newly diagnosed breast cancer across all subtypes.

How does Myriad Genetics' Precise® MRD test address the challenge of low ctDNA levels in breast cancer?

Myriad's Precise MRD test tracks up to 1,000 tumor-specific variants identified via whole-genome sequencing, making it well-suited to detect the typically low levels of ctDNA in breast cancer.