Myriad Genetics Showcases New Research and Product Innovations Advancing Cancer Care at 2024 ASCO® Annual Meeting

Rhea-AI Summary

Myriad Genetics will present data from seven studies at the 2024 ASCO Annual Meeting, focusing on breast cancer risk assessment and various innovative tests like the Precise™ MRD Test and MyChoice® CDx HRD Companion Diagnostic Test. Key presentations include the efficacy of Myriad’s RiskScore in predicting triple-negative breast cancer in Black women and the effectiveness of neoadjuvant combination therapy for advanced ovarian cancer. Myriad is also expanding its oncology portfolio with new products and research collaborations, and plans to launch commercial MRD and liquid biopsy testing by 2025. The MCRR registry, comprising data from over one million patients, supports transparent clinical data sharing.

Positive

• Presentation of seven new studies at 2024 ASCO Annual Meeting enhances Myriad's visibility.
• RiskScore improves prediction of triple-negative breast cancer in Black women.
• Neoadjuvant combination therapy for advanced ovarian cancer is effective and tolerable.
• Significant progress in germline genetic profiling for ovarian and uterine cancers.
• Expansion of oncology portfolio with new tests and innovations.
• Commercial launch of MRD and liquid biopsy testing expected in 2025.
• Collaboration with top cancer research centers like Memorial Sloan Kettering and MD Anderson.
• MCRR registry includes data from over one million patients, supporting transparent data sharing.

Negative

• Potential over-reliance on the success of future product launches like MRD and liquid biopsy testing.
• Commercial launch set for 2025 means revenue from these innovations is not immediate.
• Disparities in genetic testing results indicate the need for more inclusive research efforts.
• The effectiveness of new products still largely dependent on ongoing and future research validation.

Molecular Residual Disease (MRD) study and multiple RiskScore studies among seven new datasets to be shared by Myriad and Collaborators

SALT LAKE CITY, May 23, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, and its collaborators will share data from seven studies at the 2024 ASCO Annual Meeting. Three studies led by Myriad focus on breast cancer risk assessment, and four additional studies will be shared by collaborators that will cover the company’s Precise™ MRD Test, MyChoice^® CDx HRD Companion Diagnostic Test, and the Myriad Collaborative Research Registry™ (MCRR). At booth 25014, Myriad will highlight the value of genetic testing and genomic insights in guiding personalized cancer treatment decisions, as well as share information about upcoming product innovations including MRD and liquid biopsy testing.

New Data at ASCO

Oral Presentation: Evaluation of a polygenic risk score as a predictor of early onset triple-negative breast cancer in Black women (Abstract #: 10501)
Presenter: Holly J. Pederson, MD, Director, Medical Breast Services, Cleveland Clinic
Date: Saturday, June 1, 2024
Time: 3:12 pm CT
Description: This study demonstrates that Myriad’s RiskScore improves upon clinical factors for the prediction of triple-negative breast cancer and early onset (<50 years) triple-negative breast cancer in Black women.

Poster: Comparison of primary versus metastatic tumor tissue sources when designing panels for whole-genome-based tumor-informed ctDNA assays in clear cell renal cell carcinoma (Abstract #3039)
Date: Saturday, June 1, 2024
Time: 9:00am – 12:00pm CT
Description: In a pilot study of patients with oligometastatic renal cell carcinoma, molecular residual disease (MRD) results were largely concordant with mortality status and between monitoring panels composed of thousands of probes identified from either primary or metastatic tumors, suggesting repeat biopsy might not be necessary for long term MRD monitoring.

Poster: Improving a polygenic risk score (PRS) for breast cancer (BC) risk assessment in diverse ancestries (Abstract #: 10533)
Date: Monday, June 3, 2024
Time: 1:30 – 4:30pm CT
Description: This study highlights a new 385-SNP PRS component of RiskScore and demonstrates it is well-calibrated, improves upon clinical factors, and outperformed existing PRS in all tested ancestries for the prediction of breast cancer risk.

Poster: Association of polygenic-based breast cancer risk prediction with patient management (Abstract #: 10527)  
Date: Monday, June 3, 2024
Time: 1:30 – 4:30pm CT
Description: The study demonstrates that clinicians recommended breast cancer screening aligned with guidelines for those with ≥20% lifetime risk, regardless of whether risk was based on RiskScore or on Tyrer-Cuzick alone. 

Poster: Germline Genetic Profiles of Women with Ovarian Malignancies: A Myriad Collaborative Research Registry Study (Abstract #: 5585)
Date: Monday, June 3, 2024
Time: 9:00 am – 12:00pm CT
Description: This data shows that over 15% of patients with ovarian cancer have BRCA1/2 (12.5%) or Lynch syndrome (2.6%) pathogenetic variants varying by race, age, and tumor site. Noted disparities indicate the importance of universal testing in patients with ovarian cancer.

Poster: Germline Genetic Profiles of Women with Uterine Cancer: A Myriad Collaborative Research Registry Study (Abstract #: 5617)
Date: Monday, June 3, 2024
Time: 9:00 am – 12:00pm CT
Description: There are significant differences in germline testing results for women with uterine cancer by race, ethnicity, and age, especially in genes associated with Lynch syndrome. This has implications for immunotherapy eligibility in the advanced and recurrent setting. More work needs to be done to identify targetable mutations in minority populations.

Poster: Neoadjuvant combination treatment of olaparib and pembrolizumab for patients with HRD-positive advanced ovarian cancer (Abstract #: 5545)
Date: Monday, June 3, 2024
Time: 9:00 am – 12:00pm CT
Description: This study shows that neoadjuvant combination therapy of olaparib and pembrolizumab is effective and tolerable in patients with HRD-positive advanced ovarian cancer. BRCA1/2 mutations are associated with the efficacy of combination therapy.

Myriad Oncology Innovations
Myriad continues to expand its oncology portfolio and expertise through product innovations and the addition of new team members, including the appointment of George Daneker Jr., MD, who is the president and chief clinical officer of oncology. Myriad’s Precise™ Oncology Solutions portfolio features comprehensive germline and somatic testing options, including the MyRisk^® Hereditary Cancer Test with RiskScore^®, Precise™ Tumor Test, Prolaris^® Prostate Cancer Prognostic Test, EndoPredict^® Breast Cancer Prognostic Test, Folate Receptor Alpha (Frα) Test, and Myriad’s two FDA-approved companion diagnostic tests: MyChoice CDx HRD Companion Diagnostic Test and BRACAnalysis CDx^® Germline Companion Diagnostic Test.

Ongoing oncology developments include:

• MRD testing. Myriad’s Precise MRD is a tumor-informed, whole genome sequencing (WGS) based test that monitors hundreds to thousands of tumor-specific variants. This technology enables exceptional sensitivity and quantification of circulating tumor DNA (ctDNA) in the blood of patients with cancer. The test is currently available for use in research studies pursued jointly by Myriad and academic or pharmaceutical investigators and is expected to launch commercially in 2025.
  
  MRD research collaborations. In the past year, Myriad has announced several important research collaborations: a retrospective study of MRD efficacy in metastatic breast cancer with researchers at Memorial Sloan Kettering Cancer Center (MSK), a retrospective analysis of MRD utility in metastatic renal cell carcinoma with clinicians at The University of Texas MD Anderson Cancer Center, and a prospective pan-cancer study with MRD researchers at the National Cancer Center Hospital East in Japan. Early results from the research collaboration with MD Anderson will be shared at ASCO as a poster.
  

• Tumor profiling and liquid biopsy testing. Earlier this year, Myriad acquired select assets from Intermountain Precision Genomics’ laboratory business. By bringing Precise Tumor and Precise Liquid testing in house at Myriad's new state-of-the-art laboratory facility in Salt Lake City, the company opens new opportunities to scale and develop its portfolio. Precise Liquid is expected to launch in 2025.

• Expanding data sharing efforts. Launched in December 2023, the MCRR includes data across germline and tumor testing results from Myriad’s cancer products on more than one million patients, making it one of the largest pan-cancer registries freely available for research use and supports transparent clinical data sharing. Two of the above posters being shared at ASCO are based on data from the MCRR. Myriad is also expanding its collaboration with its technology partner DNAnexus to provide a new, interactive way for physicians to securely access their data, with more details to come later this year.
  

“As we continue to innovate and grow our oncology business, our vision remains centered around advancing oncology care for all patients,” said Dr. Daneker. “Our new research and product innovations underscore our commitment to partnering with oncologists, academic institutions and other healthcare partners to expand access to genetic and genomic testing, create equitable testing solutions for all, and provide data-driven insights that can better inform clinical care and improve outcomes for patients.”

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.   

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the data and information that the company plans to present at the 2024 ASCO Annual Meeting and updates on upcoming product innovations including MRD and liquid biopsy testing. 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 studies will Myriad Genetics present at the 2024 ASCO Annual Meeting?

Myriad Genetics will present data from seven studies, including three focused on breast cancer risk assessment and four on tests like Precise™ MRD Test and MyChoice® CDx HRD Companion Diagnostic Test.

How does Myriad’s RiskScore help in cancer prediction?

Myriad's RiskScore improves prediction of triple-negative breast cancer, particularly in Black women, and outperforms existing polygenic risk scores in diverse ancestries for breast cancer risk assessment.

When will Myriad's new MRD and liquid biopsy tests be commercially available?

Myriad expects to launch its MRD and liquid biopsy tests commercially by 2025.

What is the significance of the MCRR registry?

The MCRR registry includes data from over one million patients and supports transparent clinical data sharing, enhancing research and personalized cancer treatment.

What are the key innovations in Myriad's oncology portfolio?

Key innovations include MRD testing, liquid biopsy testing, and enhancements in germline and somatic testing options, along with new collaborations with top cancer research centers.