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Myriad Genetics Announces Inclusion of Breast Density to MyRisk with RiskScore Breast Cancer Risk Assessment

Key Takeaway: Myriad Genetics has announced the inclusion of breast density in its MyRisk® Hereditary Cancer Test with RiskScore®. This first-of-its-kind risk model integrates breast density along with family history and genetic markers to provide a comprehensive assessment of breast cancer risk. The aim is to enhance early detection and personalize patient care strategies, particularly for individuals with dense breast tissue. This innovation aligns with recent FDA regulations mandating mammography facilities to report breast density to patients.
Price reaction · baseline $23.08 (2023-07-21 close) · 1 other MYGN headline(s) in the window, move may be shared
day 0 close · peak
-4.6%

Market Sentiment Analysis

POSITIVE FACTORS

  • MyRisk with RiskScore now includes breast density for improved risk assessment.
  • The incorporation of breast density could enhance early cancer detection.
  • The new model may lead to better personalized breast care for patients.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~41 mo
Minimal dilution risk
Lead asset
SKB264
Phase 2 · Solid Tumor

Full Press Release Details

RiskScore is the first validated risk model that includes breast density, personal/family history and genetic markers
This comprehensive model is expected to identify more patients that could benefit from a change in their breast care
SALT LAKE CITY, July 24, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced its MyRisk® Hereditary Cancer Test with RiskScore® now incorporates breast density using Tyrer-Cuzick version 8 (TCv8) to provide patients and providers with a more comprehensive look at their five-year and remaining lifetime risk for breast cancer. MyRisk with RiskScore is the first breast cancer risk model that includes breast density, personal/family clinical history and a polygenic risk score (PRS) based on genetically determined ancestry.
Breast density plays a critical role in breast cancer screening and diagnosis. The Federal Drug Administration recently updated mammography regulations requiring mammography facilities to notify patients about the density of their breasts by September 2024. Higher-density tissue can make it more difficult to detect breast masses or cancer during a screening and may require additional imaging tests. The incorporation of this critical piece of information into MyRisk with RiskScore, and Myriad’s recently launched cancer risk assessment program, is expected to help providers and their imaging networks offer more personalized patient care and detect breast cancer in its early stages, when there is the greater chance of a cure.
"SimonMed uses TCv8 to estimate breast cancer risk based not only on multiple clinical factors and family history but also in particular on breast density. Higher breast density is associated with a greater risk of breast cancer,” said John Simon, MD, CEO of SimonMed and board-certified Radiologist. “We are encouraged that we can now incorporate breast density in our breast cancer risk assessment tool from Myriad Genetics. This will help save lives by helping personalize the imaging pathway."
To further reaffirm the benefits of RiskScore with TCv8, Myriad shared data from a study titled A breast cancer risk model incorporating TCv8 and a PRS for diverse ancestries at the 2022 American Society of Clinical Oncology Annual Meeting. The results showed the addition of PRS substantially improved risk stratification over TCv8 alone, and may allow for a more personalized approach to breast cancer risk reduction and early detection strategies, such as preventive medications or increased surveillance.
“Patients with dense breasts often rely on traditional screening methods that may not be enough to identify cancer at its earliest and most treatable stages,” said Melissa Gonzales, president of women’s health, Myriad Genetics. “At Myriad, we're committed to providing patients and providers with the most advanced tools to assess breast cancer risk. By validating breast density and other risk factors into RiskScore, we can provide a comprehensive breast cancer risk assessment individualized for each patient’s unique risk factors.”
For more information about MyRisk with RiskScore, please visit: https://myriad.com/hcp-myrisk-hereditary-cancer-test/.
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 inclusion of breast density to MyRisk with RiskScore breast cancer risk assessment, the expectation that the inclusion of breast density to MyRisk with RiskScore will identify more patients that could benefit from a change in their breast care and help providers and their imaging networks offer more personalized patient care and detect breast cancer in its early stages, and the company’s commitment to providing patients and providers with the most advanced tools to assess breast cancer risk. 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 March 1, 2023, 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.

Frequently Asked Questions

What is RiskScore in breast cancer assessment?

RiskScore is a validated model that evaluates breast cancer risk by including breast density, personal and family history, and genetic markers.

How does breast density affect cancer screening?

Higher breast density can hinder the detection of tumors and may necessitate additional imaging tests during screenings.

What is unique about MyRisk® with RiskScore?

MyRisk with RiskScore is the first model to integrate breast density along with clinical history and genetic risk indicators.

Why is TCv8 important for risk evaluation?

TCv8 enhances breast cancer risk assessment by considering multiple factors, including breast density, thereby improving risk stratification.

How can RiskScore help in early cancer detection?

By incorporating critical risk factors, RiskScore enables personalized risk assessments, potentially leading to earlier breast cancer detection.

Last updated: Jul 24, 2023