Genetics in Medicine Publishes Myriad Genetics Patient-Outcomes Study Validating RiskScore® as a Clinical Breast Cancer Risk Assessment Tool
03 Junho 2024 - 5:05PM
Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing
and precision medicine, today announced that Genetics in Medicine,
an official journal of the American College of Medical Genetics and
Genomics (ACMG), published a new study validating RiskScore®,
Myriad’s breast cancer risk assessment tool integrated into its
MyRisk® Hereditary Cancer Test. RiskScore combines a polygenic
risk score (PRS) validated for all ancestries with the Tyrer-Cuzick
model, a widely used breast cancer risk assessment calculator.
The study – first shared as a Spotlight
Presentation at the 2022 San Antonio Breast Cancer Symposium –
examined real-world patient outcomes from more than 130,000 women
who have taken Myriad’s MyRisk Hereditary Cancer Test with
RiskScore. The study demonstrated that RiskScore was more accurate
at stratifying women at high- or low-risk of developing breast
cancer than the Tyrer-Cuzick risk calculator alone. In fact, the
integration of RiskScore with Tyrer-Cuzick improved predictive
accuracy by roughly two-fold over Tyrer-Cuzick alone.
“This study makes substantial progress in
validating the performance of a PRS to assess breast cancer risk
among women of diverse ancestries,” said Allison Kurian, M.D.,
professor of medicine and of epidemiology and population health,
Stanford University School of Medicine. “Key findings include the
superior calibration and discrimination of the PRS, out-performing
standard breast cancer risk models, in a large, real-world medical
claims dataset. These results are an important next step in
defining the role of PRS in clinical practice.”
Guidelines recommend that women at increased risk
of breast cancer undergo additional surveillance measures, such as
an annual breast MRI. In clinical practice, approximately 1 in 5
women are reclassified by RiskScore compared to their risk
classification by Tyrer-Cuzick.1 The clinical use of RiskScore may
therefore lead to more accurate identification of women who may
benefit from enhanced breast cancer surveillance strategies.
“Comprehensive and equitable personalized breast
cancer risk assessment integrates known traditional risk factors,
germline-mutation testing, and an all-ancestry PRS. The recently
published results from a large, real-world cohort demonstrate the
value of this combination, particularly its ability to better
elucidate risk for the large majority of women who do not have a
pathogenic germline mutation,” said Dale Muzzey, chief scientific
officer, Myriad Genetics. “Incorporation of a PRS for all
ancestries into a precision medicine tool like MyRisk with
RiskScore means more women may be able to benefit from getting
finer quantitative resolution of their genetically driven risk of
developing breast cancer, and they can then work with their
physicians on how to best manage that risk.
About the StudyThis study included
women tested with MyRisk between 2017-2019 who did not carry a
pathogenic variant known to be associated with breast cancer risk
(e.g., a variant in BRCA1 or BRCA2), and without a prior diagnosis
of breast cancer. Clinical information, such as a woman’s family
history of cancer, was obtained from test request forms submitted
by providers. Patient outcomes after testing were obtained by
tokenizing and linking medical claims to clinical and genetic
testing data from Myriad to create a deidentified dataset.
Patients’ remaining lifetime risk of developing breast cancer was
calculated using Tyrer-Cuzick and RiskScore.
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 StatementThis press
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995, including
statements relating to how the incorporation of a PRS for all
ancestries into a precision medicine tool like MyRisk with
RiskScore may lead to more women being able to benefit from getting
finer quantitative resolution of their genetically driven risk of
developing breast cancer. 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.
- Hughes, Elisha, et al. "Integrating clinical and polygenic
factors to predict breast cancer risk in women undergoing genetic
testing." JCO Precision Oncology 5 (2021): 307-316.
Investor ContactMatt Scalo(801)
584-3532IR@myriad.com
Media ContactGlenn Farrell(385)
318-3718PR@myriad.com
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