-- Cardiovascular diseases are responsible for 17.9 million deaths every
year(1), a third of all deaths globally(2)
-- Roche announces five new intended uses for key cardiac biomarkers to help
identify cardiovascular risk, better diagnose patients and support early
treatment
-- Early diagnosis and treatment can contribute to saving or improving
people's lives and could help healthcare systems save money
Basel, 28 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced a
series of five new intended uses for two key cardiac biomarkers using
the Elecsys(R) technology: high sensitive cardiac troponin T (cTnT-hs)
and N-terminal pro-brain natriuretic peptide test (NT-proBNP). These
gold standard biomarkers(3) have proven to be successful in supporting
cardiovascular disease management and can help clinicians diagnose heart
attacks (cTnT-hs) and better manage heart failure (NT-proBNP). Roche's
introduction of five new intended uses for these existing, globally
accepted diagnostic solutions means more people could benefit from
improved cardiovascular diagnostics. By providing greater precision and
certainty for clinicians, Roche can help them tackle the world's biggest
killer: cardiovascular diseases.
"The five new solutions we launch this month add real value for
clinicians by supporting cardiac risk identification and improving
diagnosis. In turn, this will help them make early treatment decisions,
improve people's lives and reduce healthcare costs," said Thomas
Schinecker, CEO Roche Diagnostics. "As the market leader in
cardiovascular testing Roche is committed to innovation in
cardiovascular care and these new intended uses are the first of many
solutions planned over the next decade that could help improve the lives
of millions of people."
One of the new intended uses for Elecsys(R) NT-proBNP supports
healthcare professionals in identifying which people with type-2
diabetes (463 million worldwide ) are at higher risk of developing
cardiovascular disease . Early identification of people at risk means
cardioprotective treatment can be started sooner, which could prevent
65% of hospitalisations or deaths . The second newly-launched intended
use for NT-proBNP provides healthcare professionals with a
biomarker-based solution that identifies people at risk of developing
Atrial Fibrillation (AF), an abnormal heart rhythm that can lead to
stroke, brain damage and death . More than 37 million people suffer from
AF globally(1) . NT-proBNP, in combination with a single lead (or
higher) electrocardiogram, can help to successfully diagnose AF so
therapy can be started to reduce the stroke risk(1)(1).
Another important biomarker, Elecsys(R) cTnT-hs, now provides healthcare
professionals with data to help predict heart attack risk and mortality
in non-cardiac surgery patients. Every year, over 200 million adults
undergo major non-cardiac surgery with 10 million suffering from major
adverse cardiac events (MACE) that could be prevented through early and
accurate diagnosis(1)(2).
Both Elecsys(R) NT-proBNP and Elecsys(R) cTnT-hs can be run on all cobas
e(R) analysers. They are among the first products certified under the
new European In Vitro Diagnostics Regulation (IVDR) and available as of
today in countries accepting CE mark. Availability in other countries is
subject to local registration processes and timelines.
About Elecsys(R) NT-proBNP
Tests for NT-proBNP, a cardiac hormone that is released into the blood
when the heart wall is stretched, are developed and marketed by Roche.
NT-proBNP is an objective marker for the aid in diagnosis in individuals
suspected of having congestive heart failure and detection of mild forms
of cardiac dysfunction. This assay is further indicated for the risk
stratification of patients with acute coronary syndrome and congestive
heart failure, and it can also be used for monitoring the treatment in
patients with left ventricular dysfunction.
Added intended uses for Elecsys(R) NT-proBNP
(1) Type-2 diabetes and heart failure
463 million people suffer from type-2 diabetes worldwide and are at
higher risk of developing cardiovascular disease. The new intended use
of Elecsys(R) NT-proBNP provides healthcare professionals with a precise
biomarker that supports them to identify patients with high
cardiovascular risk. This means that effective drug treatment can be
started early so that cardioprotective treatment can be optimized. In
PONTIAC-I it was shown that 65% of hospitalisations or death could be
prevented .
(2) Atrial fibrillation
More than 37 million people suffer from Atrial Fibrillation (AF) and 25%
of people over 40 years old develop AF in their lifetime. More than 450
million people aged 70 or above are considered high risk for this
disease. Patients with AF are exposed to a fivefold risk of stroke(1)(3)
and therefore brain damage or death(1) . One of the key elements in
reducing stroke is early detection of people at risk of Atrial
Fibrillation by better identification methods. Our second launched
intended use for Elecsys(R) NT-proBNP provides healthcare professionals
with a biomarker based solution that identifies people at risk and, in
combination with a single lead (or higher) ECG, can aid successful
diagnosis so therapy can be started.
About Elecsys(R) cTnT-hs
The Elecsys cardiac Troponin T high-sensitivity (cTnT-hs) test from
Roche, detects cardiac troponin which is the guideline recommended
biomarker for the diagnosis of heart attack in clinical practice. In
combination with an electrocardiogram (ECG), high-sensitive Troponin has
become the gold standard for the diagnosis of heart attack. Using the
accelerated ESC 0/1 hour algorithm with the Elecsys cTnT-hs assay,
significantly accelerates "rule-in" and "rule-out" decision-making,
thereby maximising the potential for effective treatment. At the same
time, the faster decision-making may help to better manage the emergency
room workload and related costs for healthcare systems(1) .
Added intended uses for Elecsys(R) cTnT-hs in coronary artery disease
(3) Over 200 million adults globally undergo major non-cardiac surgery
every year. Of these, over 10 million suffer from major adverse cardiac
events (MACE) in the first 30 days after non-cardiac surgery and more
than 80% of those are clinically asymptomatic. The new intended use for
Elecsys(R) cTnT-hs provides healthcare professionals with a biomarker
that helps to predict the perioperative risk of a heart attack and to a
perioperative heart attack in non-cardiac surgeries to allow clinicians
to tailor surgery and post-operative care accordingly.
(4) The second newly-launched intended use for Elecsys(R) cTnT-hs makes
the biomarker serve as an aid in assessing the long-term risk of
cardiovascular events (death, myocardial infarction, coronary
revascularisation, heart failure or ischemic stroke) in asymptomatic
individuals.
(5) Elecsys(R) cTnT-hs is the gold standard for triaging patients
suspected of Acute Coronary Syndrome in Emergency Departments and
Intensive Care Units The third launched intended use for this biomarker
can help to improve early discharge and outpatient management of these
patients.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics under one roof have made Roche the
leader in personalised healthcare -- a strategy that aims to fit the
right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology
and diseases of the central nervous system. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics, and
a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent,
diagnose and treat diseases and make a sustainable contribution to
society. The company also aims to improve patient access to medical
innovations by working with all relevant stakeholders. More than thirty
medicines developed by Roche are included in the World Health
Organization Model Lists of Essential Medicines, among them life-saving
antibiotics, antimalarials and cancer medicines. Moreover, for the
twelfth consecutive year, Roche has been recognised as one of the most
sustainable companies in the Pharmaceuticals Industry by the Dow Jones
Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over
100 countries and in 2020 employed more than 100,000 people worldwide.
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF
58.3 billion. Genentech, in the United States, is a wholly owned member
of the Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] 17.9 M deaths:
https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1
[2] A third of all deaths: Mensah, G. A., et al. (2019). "The Global
Burden of Cardiovascular Diseases and Risk Factors." 2020 and Beyond
74(20): 2529-2532
[3] Gold standard biomarkers: Ohman EM. Clin Chem 2017; 63: 429
Gold standard biomarkers: McKie, PM., et al. (2016). J Am Coll Cardiol
68(22), 2437-2439
[4] Help clinicians diagnose heart attacks (cTnT-hs): Roff M et al, Eur
Heart J 2016; 37: 267
Help clinicians diagnose heart attacks (cTnT-hs): Amsterdam EA et al.,
Circulation 2014;130:2354
[5] Better manage heart failure (NT-proBNP): Ponikowski P et al., Eur
Heart J 2016; 37:2129
Better manage heart failure (NT-proBNP): Yancy CW et al, Circulation.
2017;136:e137;
[6] 463 million diabetics worldwide: Saeedi P et al., Diabetes Res Clin
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