T2 Biosystems Announces New T2Bacteria RUO Panel Data Presented at AMP 2017
November 20 2017 - 9:26AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of
innovative diagnostic products for critical unmet needs in
healthcare, today announced new data presented on the T2Sepsis
Solution™ during the Association for Molecular Pathology (AMP) 2017
Conference in Salt Lake City, UT. These data highlight the
potential clinical value that may be achieved using the T2Bacteria®
Panel compared to results from blood culture.
Chiagozie Ononye, M.D. of Northwestern University’s Feinberg
School of Medicine presented data from 61 patient samples that were
tested using the T2Bacteria for Research Use Only (RUO) Panel. The
retrospective study compared T2Bacteria results both to blood
culture results and to the case history of each patient to
determine the accuracy and potential impact of the T2Bacteria Panel
for patient care. The analysis concluded that the T2Bacteria RUO
Panel:
- Detected true, confirmed bacterial infections better than blood
culture.
- Identified 72% of infections, a higher rate than any other
method in the study, including blood culture, which only identified
40% of cases.
- Identified 9 infections confirmed by other methods that were
not identified by blood culture.
- Distinguished ineffectively treated infections from those that
could be contained and cured in cases that were not identified by
blood culture.
Dr. Ononye posited that an early result from the T2Bacteria
Panel could enable clinicians to treat the source of infection and
begin targeted antimicrobial therapy far earlier in the clinical
care pathway, which are the most effective methods to improve
patient outcomes. Today, the T2Bacteria Panel is CE Marked and
commercially available in Europe, and is currently under review by
the Food and Drug Administration (FDA) for market clearance in the
United States.
“At Northwestern, we are particularly interested
in exploring the added clinical value from T2Bacteria and
T2Candida Panel results. In our retrospective study, the T2Sepsis
Solution correctly identified the causative pathogen
in infected patients where blood culture was negative,” said
Dr. Ononye. “If confirmed in prospective trials, getting these
clinically relevant results in 3 to 5 hours offers an
opportunity to improve patient outcomes and the quality of patient
care.”
The T2Bacteria Panel is a part of the T2Sepsis Solution, a
unique approach to the overall care of patients who have or might
develop sepsis. These newly reported data add to the many studies
that have proven the excellent clinical performance of the T2Sepsis
Solution due to these important characteristics:
- Time to result 40x faster than blood culture based
methods.
- Clinical sensitivity in the range of 90-100% as shown in more
than 300 cases across several studies of known infected patients
compared to the reported 50-65% sensitivity of blood culture.
- Clinical specificity on average of approximately 98% across
over 3,000 patients tested at 15
institutions.
“I am very pleased that studies conducted by hospital users
continue to demonstrate that the T2Bacteria RUO Panel test results
are strongly indicative of true infections in patients with
negative blood cultures,” said Tom Lowery, Ph.D., chief scientific
officer of T2 Biosystems. “This and other studies have shown that
the T2Sepsis Solution is detecting infections for which early and
sensitive identification can lead to faster time to appropriate
treatment – for example, infections in the lungs where it is likely
to start to spread throughout the body. In a case like this,
T2Bacteria should help physicians get patients on a targeted
therapy faster.”
Videos of the full presentations by Dr. Ononye and Dr. Lowery
are available here.
About T2 Biosystems T2 Biosystems, a leader in
the field of innovative in vitro diagnostics that solves critical
unmet needs in healthcare, improves patient care and reduces the
cost of healthcare by helping clinicians effectively treat patients
faster than ever before. For more information, please visit
www.t2biosystems.com.
About the T2Sepsis SolutionSepsis, one of the
deadliest and most expensive conditions in hospitals today, is the
focus of the T2Sepsis Solution, a unique approach that combines the
standard of care for the management of sepsis patients with T2
Biosystems’ products, including the T2Dx® Instrument and T2Candida
Panel, and the T2Bacteria Panel. Powered by the proprietary T2
Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is
proven to deliver better patient care and greater cost savings. It
has demonstrated faster time to effective treatment, shortened ICU
and hospital lengths of stay, reduced use of unnecessary
antifungals, and millions of dollars in savings. T2Bacteria Panel
is commercially available in Europe and other countries that accept
the CE Mark and is available for research use only in the U.S.
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Company Contact:Darlene Deptula-Hicks, T2
BiosystemsSVP & Chief Financial
Officerddeptula@t2biosystems.com603-553-5803
Media Contact:Amy Phillips, Feinstein Kean
Healthcareamy.phillips@fkhealth.com412-327-9499
Investor Contact:Chris Brinzey, Westwicke
Partners chris.brinzey@westwicke.com339-970-2843
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