septiSTAT™
Overview
septiSTAT™ is a rapid cell-based assay used to determine immune system hyperactivation associated with sepsis in critically ill patients. Sepsis represents a severe
illness associated with bacterial infections of the blood. The disease has a very high
mortality (30-50%) and is considered the most expensive hospital-associated
pathology seen in modern medicine. There are approximately 750,000 cases of
sepsis in the United States annually and the diagnostic component of the disease is
estimated at $3-$5 Billion annually, and total expenditures, including therapeutics,
is estimated at over $20 Billion.
Current Methodologies for Diagnosing Sepsis
Sepsis is currently defined as a state of body-wide inflammation with the addition of
a positive blood culture. It is considered a difficult disease to diagnose, namely
because systemic inflammation can be caused by non-infectious reasons, such as
trauma, myocardial infarction, and cancer. Current diagnostic tests are
acknowledged as having less than optimal sensitivity and specificity. These tests
include serum lactate (a marker of organ dysfunction), C-reactive protein (a marker
of inflammation), and procalcitonin. Procalcitonin is a newly developed sepsis
biomarker whose developer, Brahms Diagnostics, was sold to Thermo Fisher for
$500 Million in 2008. Recent data has called into question the specificity of
procalcitonin for diagnosing sepsis.
septiSTAT
The septiSTAT™ test is a cell-based assay being developed with help from the
University of Rochester School of Medicine. septiSTAT™ represents the quantitative
assessment of two biomarkers representing the two phases of sepsis. The first
marker, VLA-3, has been determined by University of Rochester researchers to be
over expressed on neutrophils, a type of white blood cell, in sepsis patients. This
marker represents the hyper-stimulated immune system seen in the systemic
inflammation phase of sepsis. The second marker, CTLA-4, is a marker related to the
anti-inflammatory phase of sepsis called Compensatory Anti-inflammatory
Response Syndrome (CARS). CARS often predicts a patient’s entry into Septic Shock
and has a very high associated mortality rate.
septiSTAT™ will be the first and only test on the market to inform clinicians
regarding where there suspected sepsis patients are in the phases of sepsis,
allowing better treatment decision and reduced mortality. The test will function in
an automated fashion on the RAPID-B platform and when coupled with the
bacSTAT™ test will offer a complete solution for monitoring critically ill patients for
infections.
Market Landscape
The diagnosis of sepsis is a difficult clinical challenge. There is a lack of consensus
regarding appropriate biomarker profiles for aiding the clinical diagnosis. The
current offerings focus on serum-based markers such as C-reactive protein, lactate
levels, and procalcitonin. Recent evidence supports the questionable sensitivity and
specificity of these biomarkers. For this reason we are focusing on biomarkers
directly involved with monitoring immune status because it is acknowledged that
immune system hyper-stimulation is a component of all sepsis cases. Additionally it
is coming to light that septic shock involves a compensatory anti-inflammatory
immune response. The approach of assessing both phases of sepsis will be a first for
the industry.