Superiority of Cardiac Biomarker ST2 over Natriuretic Peptide Markers and Galectin-3 Featured In YouTube Video

  Superiority of Cardiac Biomarker ST2 over Natriuretic Peptide Markers and
  Galectin-3 Featured In YouTube Video

Business Wire

SAN DIEGO -- November 12, 2012

Critical Diagnostics, makers of the Presage® ST2 Assay, announced today that a
videotaped lecture by noted cardiologist James Januzzi, Jr., MD,Associate
Professor of Medicine at Harvard Medical School and Director, Cardiac
Intensive Care Unit at Massachusetts General Hospital, discussing his views
and opinions regarding the powerful role of the cardiac biomarker ST2 in
shifting the paradigm in the management of heart failure patients, has been
posted on YouTube for immediate viewing.

The 47-minute video is a culmination of the clinical and research evidence
surrounding ST2 in predicting heart failure above and beyond existing
biomarkers, including BNP from Alere (NYSE:ALR), Roche Diagnostics’ NT-proBNP
(OTCQX: RHHBY) and Galectin-3 from BG Medicine (NASDAQ:BGMD). Dr. Januzzi
highlights the current gaps in the clinical management of heart failure
patients and, from his experience, provides medical scenarios where ST2 can
make an immediate impact in directly influencing care and management of heart
failure patients, potentially reducing healthcare costs and risk of adverse

“We have done a lot of work to evaluate ST2 and have unequivocal evidence that
ST2 adds and supersedes, actually, the natriuretic peptides for multiple
applications,” Dr. Januzzi stresses in his lecture. “We examined a number of
different biomarkers, including ST2, relative to their ability to
prognosticate . . . not a single one was even close to the value of ST2 for
prognosis . . . ST2 has been shown to be of value across all four stages of
heart failure.

“In the [HF-ACTION] study, Galectin-3 appeared to be prognostically meaningful
when it was placed in an unadjusted model, but the moment either NT-proBNP or
renal function was entered into the model, Galectin-3 fell out. In contrast,
ST2 survived adjustment for both NT-proBNP and renal function, maintaining its
prognostic power. ST2 is independent of renal function, body mass index and a
number of relevant covariates.

“The real question now is, can we harness this utility [of ST2] for prognosis
to improving outcomes for patients? That is the goal. In PROTECT, a chronic
ambulatory treatment study, we measured ST2 values at each visit and assessed
its ability to predict risk from visit to visit, and in addition examined what
an elevated ST2 value meant in this context relative not only to outcomes, but
relative to changes on these patients’ echo cardiograms and ultimately their
treatments. ST2 changed considerably, very much in parallel with the clinical
picture that these patients presented visited with . . . unlike other
biomarkers like Growth Differentiation Factor 15 (GDF-15), highly-sensitive
troponin and Galectin-3.

“ST2 has been shown to be of value across all four stages of heart failure . .
. It has been shown repeatedly that ST2 reclassifies risk above and beyond
other biomarkers, suggesting that it provides unique biological information to
tests we already have.”

“This engaging video lecture is proof of the pathway ST2 is paving in
revolutionizing care for heart failure patients,” notes Dr. James Snider,
President of Critical Diagnostics. “We concur with Dr. Januzzi when he says,
‘this biomarker is here to stay and will be used in a wide range of patients,
heart failure as well as others.’”

The video can be viewed on YouTube under ST2 Cardiac Biomarker, or by using
this link:

About ST2

Soluble ST2 has now been published in more than 100 peer-reviewed articles and
scientific posters studying more than 35,000 patients. These clinical studies
have demonstrated that high levels of soluble ST2 are predictive of adverse
patient outcomes and death in a broad spectrum of cardiovascular disease. They
have further shown that the prognostic information from soluble ST2 is
independent of, and provides added information to, that of cardiac biomarkers
commonly used today.

About Critical Diagnostics

Critical Diagnostics ( develops novel biomarkers
to help physicians optimize patient care in cardiovascular diseases, while
containing healthcare costs. The Presage ST2 Assay has been CE Marked and
cleared by the US FDA for use in risk stratification with chronic heart
failure patients. Critical Diagnostics has exclusive worldwide rights to ST2
for the diagnosis and prognosis of cardiovascular disease.


Critical Diagnostics
Dennis Dalangin, VP Marketing
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