Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in precision
medicine, announced that its Myriad Autoimmune business unit will
present new data on the Vectra test at the 2019 ACR/ARP Annual
Meeting being held Nov. 8-13, 2019 in Atlanta, GA. The key
findings are that the Vectra test predicts the risk of radiographic
progression (RP) within one year, and the Vectra score, in
combination with other clinical measures, predicts the risk of a
cardiovascular (CV) event in people with rheumatoid arthritis (RA).
“A hallmark feature of rheumatoid
arthritis is inflammation, which increases the risk of
joint damage, cardiovascular disease and other comorbidities,” said
Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical
officer at Myriad Autoimmune. “The data being presented by our
academic collaborators at ACR show that the Vectra test accurately
measures inflammation and can help predict patients’ risk of
adverse health outcomes, enabling clinicians to tailor precision
treatment plans to achieve better outcomes.”
Vectra Posters
Title: Predicting Risk of Radiographic
Progression for Patients with Rheumatoid
Arthritis.Presenter: Jeff Curtis, M.D., M.S.,
MPH, University of Alabama at
Birmingham.Date: Sunday, Nov. 10, 2019.
9:00-11:00 a.m.Location: Poster 466.
This study evaluated the ability of the Vectra test to predict
patients’ “individual percentage risk” of RP within one year. The
analysis included combined data from 973 patients in four cohorts.
The results demonstrate that the adjusted Vectra score was a
superior predictor of RP within one year compared to DAS28-CRP,
CRP, CDAI and swollen joint count. Additionally, the risk of
permanent joint damage increased continuously with the adjusted
Vectra score, meaning patients with a low adjusted Vectra score had
a one to three percent risk of RP in one year, while patients with
a moderate-to-high score had between seven and 47 percent risk
(Graph 1). Based on these new data, the company is working to
enhance the Vectra test report to provide patients with their
“individual risk” of radiographic progression in one
year.
To view Graph 1: Vectra Predicts Risk of Radiographic
Progression in 1
Year, please visit the
following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/514919cd-81ca-4084-81df-682fedc1784b
“Too often people with RA are over- or under-treated because it
is difficult for clinicians to accurately measure inflammation and
determine the long-term prognosis of RA patients. As a result, some
people are at increased risk of rapid radiographic progression,”
said Jeff Curtis, M.D., M.S., MPH, lead investigator,
rheumatologist and Professor of medicine in the Division of
Clinical Immunology and Rheumatology at the University of Alabama
at Birmingham. “It is critical that clinicians have reliable
information when making treatment decisions. Our study demonstrated
that the Vectra score was the strongest predictor of radiographic
progression, which may help inform treatment plans and prevent
future joint damage.”
Title: Derivation and Validation of a
Biomarker-Based Cardiovascular Risk Prediction Score in Rheumatoid
Arthritis.Presenter: Jeff Curtis, M.D., M.S.,
MPH; University of Alabama at
Birmingham.Date: Tuesday, Nov. 12, 2019.
9:00-11:00 a.m.Location: Poster 2350.
This study evaluated 30,751 Medicare patients with RA to develop
and validate the Vectra CVD score, which predicts risk for a first
cardiovascular (CV) event by combining data from Vectra and
clinical measures. The primary CV outcome was a composite of three
types of CV events – heart attack, stroke, and CV death – occurring
within 3 years from testing. When the performance of the Vectra CVD
score was compared to four other CV prediction models, the Vectra
CVD score was a significant predictor of CV risk and was superior
to all four other models. Importantly, when risk scores were
converted to 3-year percentage risk for having a CV event,
approximately 80 percent of patients were found to have a moderate
or high risk of a CV event over 3 years, based on risk categories
analogous to those of the American College of Cardiology/American
Heart Association 2018 guidelines (Graph 2).
To view Graph 2: Vectra Predicts Risk of Cardiovascular
Events in Patients with RA, please visit the following
link: https://www.globenewswire.com/NewsRoom/AttachmentNg/c902b4ec-a3c8-439f-9557-0a9b05631a1f
“People with rheumatoid arthritis have almost double the risk of
heart attack, stroke and atherosclerosis. Traditional CV risk
factors alone do not fully explain the increased rates of CV events
in RA, and inflammation is a missing component that is measured by
the Vectra test,” said Dr. Curtis. “In this study, the Vectra CVD
score effectively predicted CV risk in people with RA. We believe
the Vectra CVD score may assist clinicians to more quickly identify
patients at high risk for CV events and target interventions that
can be potentially life-saving.”
The company plans to publish these new data in peer reviewed
medical journal and make the Vectra CVD score available to
clinicians in fiscal year 2020. Please visit Myriad Autoimmune at
booth #1419 to learn more about Vectra. Follow Myriad on Twitter
via @myriadgenetics and follow meeting news by using the hashtag
#ACR19.
About Vectra®Vectra is a
multi-biomarker molecular blood test that provides an objective and
personalized measure of inflammatory disease activity in patients
with rheumatoid arthritis. Vectra provides unsurpassed ability to
predict radiographic progression and can help guide medical
management decisions with the goal of improving patient outcomes.
Vectra testing is performed at a state-of-the-art CLIA (Clinical
Laboratory Improvement Amendments) facility. Test results are
reported to the physician five to seven days from shipping of the
specimen. Physicians can receive test results by fax or the private
web portal, VectraView. For more information on Vectra, please
visit: www.vectrascore.com.
About Myriad GeneticsMyriad
Genetics Inc. is a leading precision medicine company dedicated to
being a trusted advisor transforming patient lives worldwide with
pioneering molecular diagnostics. Myriad discovers and
commercializes molecular diagnostic tests that: determine the risk
of developing disease, accurately diagnose disease, assess the risk
of disease progression, and guide treatment decisions across six
major medical specialties where molecular diagnostics can
significantly improve patient care and lower healthcare costs.
Myriad is focused on five critical success factors: building upon a
solid hereditary cancer foundation, growing new product volume,
expanding reimbursement coverage for new products, increasing RNA
kit revenue internationally and improving profitability with
Elevate 2020. For more information on how Myriad is making a
difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris,
Foresight and Prequel are trademarks or registered trademarks of
Myriad Genetics, Inc. or its wholly owned subsidiaries in the
United States and foreign countries. MYGN-F, MYGN-G.
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 the Company presenting new data on the
Vectra test at the 2019 ACR Annual Meeting; the Vectra test
enabling clinicians to tailor precision treatment plans to achieve
better outcomes; the Vectra score helping inform treatment plans
and prevent future joint damage; the Vectra CVD score assisting
clinicians to more quickly identify patients at high risk for CV
events and target interventions that can be potentially
life-saving; publishing these new data in peer reviewed medical
journal; making the Vectra CVD score available to clinicians in
fiscal year 2020; and the Company's strategic directives under the
caption "About Myriad Genetics." These "forward-looking statements"
are based on management's current expectations of future events and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our molecular diagnostic tests and
pharmaceutical and clinical services may decline; risks related to
our ability to transition from our existing product portfolio to
our new tests, including unexpected costs and delays; risks related
to decisions or changes in governmental or private insurers’
reimbursement levels for our tests or our ability to obtain
reimbursement for our new tests at comparable levels to our
existing tests; risks related to increased competition and the
development of new competing tests and services; the risk that we
may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and pharmaceutical and
clinical services in a timely manner, or at all; the risk that we
may not successfully develop new markets for our molecular
diagnostic tests and pharmaceutical and clinical services,
including our ability to successfully generate revenue outside the
United States; the risk that licenses to the technology underlying
our molecular diagnostic tests and pharmaceutical and clinical
services and any future tests and services are terminated or cannot
be maintained on satisfactory terms; risks related to delays or
other problems with operating our laboratory testing facilities and
our healthcare clinic; risks related to public concern over genetic
testing in general or our tests in particular; risks related to
regulatory requirements or enforcement in the United States and
foreign countries and changes in the structure of the healthcare
system or healthcare payment systems; risks related to our ability
to obtain new corporate collaborations or licenses and acquire new
technologies or businesses on satisfactory terms, if at all; risks
related to our ability to successfully integrate and derive
benefits from any technologies or businesses that we license or
acquire; risks related to our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products and services; the
risk that we or our licensors may be unable to protect or that
third parties will infringe the proprietary technologies underlying
our tests; the risk of patent-infringement claims or challenges to
the validity of our patents or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical services
and patents or enforcement in the United States and foreign
countries, such as the Supreme Court decision in the lawsuit
brought against us by the Association for Molecular Pathology et
al; risks of new, changing and competitive technologies and
regulations in the United States and internationally; the risk that
we may be unable to comply with financial operating covenants under
our credit or lending agreements; the risk that we will be unable
to pay, when due, amounts due under our credit or lending
agreements; and other factors discussed under the heading "Risk
Factors" contained in Item 1A of our most recent Annual Report on
Form 10-K for the fiscal year ended June 30, 2019, which has been
filed with the Securities and Exchange Commission, as well as any
updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All
information in this press release is as of the date of the release,
and Myriad undertakes no duty to update this information unless
required by law.
Media
Contact: |
Ron
Rogers |
Investor
Contact: |
Scott
Gleason |
|
(801) 584-3065 |
|
(801) 584-1143 |
|
rrogers@myriad.com |
|
sgleason@myriad.com |
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