Critical Diagnostics announced today it has expanded its cardiac
biomarker testing product portfolio by CE marking the Aspect-PLUS™ ST2
test, the world’s first and only rapid quantitative ST2 test. Results
are reported in under 30 minutes.
The Aspect-PLUS™ ST2 test can aid clinicians in assessing risk, making
treatment decisions, evaluating therapy effectiveness, and monitoring
patient care.
The Aspect-PLUS test is not currently available for sale in the
United States.
The Aspect-PLUS ST2 test is ideal for hospital and independent
laboratories. The test is performed by depositing a plasma sample and
reagent on a small, single-use Aspect-PLUS cartridge, which is then
placed in the shoebox-sized Aspect READER. There’s nothing else for the
operator to do. The entire analytical phase of the process is automated.
“As highlighted by the growing health and economic burden of heart
failure globally, it is clear that the widespread availability of novel
clinical tools that immediately and effectively impact outcomes is
needed,” remarks David Geliebter, CEO of Critical Diagnostics. “We’re
committed to this pursuit and the Aspect-PLUS ST2 test is proof of that.”
A recently-published European-based study1 demonstrated ST2
values accurately predict heart failure event risk. Levels of ST2 were
measured at presentation to the emergency department and after 48 hours
in 207 patients with acute heart failure. In univariate analysis the
percentage change of ST2 over the first 48 hours significantly predicted
long-term mortality.
In multivariable analysis, the predictive potential of early ST2 changes
persisted after the adjustment for ADHERE risk factors (blood urea
nitrogen, systolic blood-pressure and serum creatinine), traditional
markers of inflammation (total white cell count and high- sensitive
C-reactive protein), BNP, troponin T, percentage BNP changes during the
first 48 hours as well as the cumulative diuretic dose administered
during the first 48 hours.
“This study clearly showed that the change in ST2 values over the first
48 hours of acute heart failure hospitalization reflect the patients’
prognosis and response to therapy,” noted James Snider, Ph.D., President
of Critical Diagnostics. “One of the most interesting findings was that
higher risk patients—those whose ST2 didn’t drop by 20% or more over
this 48-hour window—but who received more intensive outpatient care did
as well as patients whose ST2 levels did decrease by more than 20%,
demonstrating that risk can be attenuated.”
In a recently-published review article,2 authors Dr. Antoni
Bayes-Genis of Hospital Universitari Germans Trias i Pujol, Barcelona
and Dr. Lori Daniels of University of California, noted, “ST2 is an
assay that has come of age and is now a clinically useful tool for risk
stratification of patients with acute and chronic HF (heart failure), as
well as patients at risk for HF. The information gleaned from ST2 levels
is complementary to that obtained from NPs (natriuretic peptides).
“Because elevated ST2 levels are so closely related to risk of adverse
outcomes including short-term hospital readmission, they have immediate
clinical implications for providers. Identifying at-risk patients,
either prior to hospital discharge or in an ambulatory clinic setting,
can help providers preferentially focus attention and resources there,
where they are most needed.”
In another recently published paper (“Biomarker-assist score for reverse
remodeling prediction in heart failure: The ST2-R2 score,” Josep Lupon
et al, International Journal of Cardiology 184 [2015] 337–343),
ST2, in conjunction with five clinical variables3, was able
to predict reverse remodeling. Remodeling refers to the changes in size,
shape, structure and physiology of the heart after injury to the
myocardium. Understanding the components of this process with the goal
of stopping or reversing its progression is often termed 'reverse
remodeling.'
In this just over 300-person, multicenter study several biomarkers
including Critical Diagnostics’s ST2, NT-proBNP, high-sensitive
troponin, both from Roche (OTC:RHHBY), and Galectin-3 (NASDAQ: BGMD),
were evaluated to determine if any added to the ability to predict
reverse remodeling over clinical variables alone. In a rigorous
multivariate analysis, only ST2 survived and was statistically
independently associated with reverse remodeling, reclassifying some 15%
of patients over the clinical model alone. Patients in the study with
reverse remodeling had a 3-fold lower
incidence of clinical events, defined as cardiovascular death of heart
failure hospitalization over the one year follow up.
The Aspect-PLUS ST2 test is available through Critical Diagnostics’
extensive network of exclusive European distribution partners, including
(in alphabetical order) Assut-Europe (Italy/Belarus), Bestbion
(Germany/Austria), Cruinn (Ireland), Eurobio (France), Genloxa (Poland),
INyDIA (Spain/Portugal), IVD Bulgaria (Bulgaria), Life Biomedical (UK),
Maritim (Croatia/Slovenia), Nordic Diagnostica (Sweden), Ruwag
Diagnostics (Switzerland), and Sopachem (Benelux).
The Aspect-PLUS ST2 test will be on display at the upcoming European
Society of Cardiology (ESC) Heart Failure 2015 Congress in Seville,
Spain in late May.
About Heart Failure
Heart failure is a condition in which the heart can't pump enough blood
to meet the body's needs. As noted by Professor Eugene Braunwald in “The
War Against Heart Failure,” in The Lancet,4 Heart
failure is a global problem with an estimated prevalence of 38 million
patients worldwide, and a number that is increasing with the aging of
the population. Heart failure is the most common diagnosis in patients
aged 65 years or older admitted to hospital. Despite some progress, the
prognosis of heart failure is worse than that of most cancers.
About ST2
ST2 is a soluble protein expressed by the heart in response to disease
or injury. It is reflective of ventricular remodeling and cardiac
fibrosis associated with heart failure. ST2 is not adversely affected by
confounding factors such as age, body mass index and impaired renal
function. Unlike many other cardiac biomarkers, ST2 levels change
quickly in response to changes in the patient’s condition—thus helping
physicians make informed decisions on an appropriate course of action to
take and, if needed, to quickly adjust treatment. All this makes ST2 an
ideal serial biomarker for monitoring and treating heart failure
patients. Since 2013 there have been over 400 scientific papers and
abstracts published on ST25.
About Critical Diagnostics
Critical Diagnostics (www.criticaldiagnostics.com)
develops novel biomarkers to help physicians optimize patient care in
cardiovascular diseases, while containing healthcare costs. The
Aspect-PLUS ST2 test and the Presage® ST2 Assay from Critical
Diagnostics are the only commercially available ST2 biomarker tests in
the world. The Presage ST2 Assay has been CE Marked and cleared by the
U.S. FDA for use in the risk stratification of chronic heart failure
patients. The Aspect-PLUS ST2 test is CE Marked.
1 “Heart Failure Therapy Induced Early ST2 Changes May Offer
Long-term Therapy Guidance,” Journal of Cardiac Failure, 2013.
2
“Using ST2 in cardiovascular patients: a review,” Future Cardiology, 2014.
3
Age, non-ischemic etiology of HF, NYHA functional class, baseline LVEF,
absence of left bundle branch block.
4 Published online
November 16, 2014
5 Based on PubMed.com listings.
Copyright Business Wire 2015