Robust Clinical Data and Positive Customer Experience with T2Bacteria and T2Candida Panels Highlighted at Recent Medical Meet...
May 23 2019 - 11:08AM
T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the
development of innovative medical diagnostic products for critical
unmet needs in healthcare, highlighted the latest clinical data and
customer case studies for the T2Bacteria® and T2Candida® Panels
that were presented at recent medical meetings.
In April, case studies of patients tested with the T2Bacteria
Panel and T2Resistance™ Panel were presented at the European
Congress of Clinical Microbiology & Infectious Diseases
(ECCMID) in Amsterdam in an Integrated Symposium by Dr. Giulia De
Angelis from the Institute of Microbiology, Università Cattolica
del Sacro Cuore, Fondazione Policlinico Universitario Agostino
Gemelli in Rome, Italy. Key highlights from the case studies:
- Three T2Bacteria clinical cases were reviewed showing an
approximately 24 hour to 37 hour time savings over
direct-from-blood-culture MALDI Biotyper and one T2Bacteria
clinical case of culture-negative sepsis missed altogether by blood
culture but detected by the T2Bacteria Panel.
- Multiple T2Carba Resistance+ clinical cases were reviewed
showing an average of a 30 hour time savings (ranging from
approximately 2 to 90 hours) with T2Carba Resistance+ over
direct-from-blood-culture PCR methods.
- For T2Bacteria panel, Dr. De Angelis concluded:
- “Study and clinical cases demonstrate the
ability of the T2Bacteria Panel to detect infections and
poly-microbial infections faster than blood culture.”
- “Clinical case study demonstrates the ability
for T2Bacteria to detect probable infections missed by blood
culture.”
- For the T2Resistance Panel, Dr. De Angelis concluded:
- “Case studies demonstrate the opportunity for
direct-from-blood resistance gene detection to provide results
faster than blood culture-based diagnostics and to impact clinical
care.”
In addition to Dr. De Angelis’ presentation during the
Integrated Symposium, which was viewed by approximately 400
attendees, Professor Michael Bauer, MD, of Jena University; Dr.
Cornelius (Neil) Clancy, of The University of Pittsburgh Medical
Center; and Dr. Thomas Walsh, of New York Presbyterian Hospital
gave presentations covering additional patient case studies and
providing an overview of the application and clinical results using
the T2Bacteria and T2Candida Panels for a variety of patients. Key
highlights from these presentations:
- Professor Bauer noted that “appropriate and rapid delivery of
targeted antimicrobials is critical for surviving sepsis” and that
rapid diagnostic tests can provide “cost savings with antimicrobial
use as well as a reduction of length of stay associated
costs.”
- Dr. Clancy provided patient case studies and noted that the
T2Bacteria Panel is appropriate for a variety of patients,
including those in the high-risk intensive care unit and the
emergency department.
- Dr. Walsh concluded that the T2Bacteria and T2Candida Panels
could improve outcomes for immunocompromised patients by providing
earlier diagnosis and more sensitive detection of blood stream
pathogens, thereby reducing length of stay and improving the chance
of survival.
In addition, several poster presentations covering the
T2Bacteria, T2Candida, and T2Resistance Panels were presented at
ECCMID and the T2 Biosystems team met with potential customers at
the Company’s booth and provided demonstrations on the ease-of-use
of the T2Dx Instrument.
In May, new data supporting the use of the T2Bacteria and
T2Candida Panels to improve antimicrobial stewardship programs was
presented at the 22nd Annual MAD-ID (Making a Difference in
Infectious Diseases) Meeting, The Antimicrobial Stewardship Meeting
in Orlando, Florida. The Company hosted a satellite symposium that
was viewed by approximately 200 attendees, and presented two
scientific poster presentations. Key highlights from the symposium
and posters:
- Dr. Deanne Tabb of Piedmont Columbus Regional Midtown in
Columbus, Georgia shared that use of the T2Bacteria Panel resulted
in improved time to appropriate antibiotics and vancomycin trough
goals, timely infectious diseases consultations for Staphylococcus
aureus bacteremia and timely initiation of contact precautions. It
also detected a case of blood culture negative K. pneumoniae
pneumonia infection.
- Dr. Ryan Shields of The University of Pittsburgh Medical Center
shared the successful results of T2Candida utilization as an
antimicrobial stewardship tool, highlighting a 47% reduction in
antifungal utilization.
All of the presentation slides and poster presentations from the
ECCMID and MAD-ID meetings are available on the Publications and
Presentations page of the T2 Biosystem’s website.
“The body of clinical evidence supporting the T2Bacteria and
T2Candida Panels continues to grow, with impressive updates at the
ECCMID and MAD-ID meetings,” said Tom Lowery, chief scientific
officer of T2 Biosystems. “There are now more than two dozen
published abstracts, clinical cases, and peer-reviewed studies
covering our panels and we reached an important milestone with the
publication of the T2Bacterial pivotal clinical trial results in
the Annals of Internal Medicine, which is a high-impact
peer-reviewed publication. It is encouraging that data continues to
reinforce the key differentiating factors that are driving adoption
of our test panels – a multi-day time advantage versus
blood-culture dependent tests, with high sensitivity and
specificity, which translates to better clinical outcomes, improved
antimicrobial stewardship, and cost savings.”
The T2Bacteria and T2Candida Panels are the first and only
FDA-cleared bacterial and fungal pathogen detection panels that are
performed directly from a blood draw, without the wait for blood
culture. They are able to identify sepsis-causing pathogens within
3 to 5 hours directly from whole blood, instead of days required
with blood culture based diagnostics. This gives clinicians
actionable information much earlier than was previously possible,
allowing them to make more informed treatment plans for escalation
or de-escalation of antimicrobial therapy. For example the
T2Bacteria Panel covers 90% of the ESKAPE pathogens, which are
particularly pathogenic and dangerous bacteria.
In addition, earlier this year, the Company announced that the
FDA granted Breakthrough Device designation for the T2Resistance
Panel, a diagnostic panel that can detect 13 resistance genes from
both gram-positive and gram-negative pathogens from a single
patient blood sample, without the wait for blood culture.
About T2 Biosystems T2 Biosystems, a
leader in the development and commercialization of innovative
medical diagnostic products for critical unmet needs in healthcare,
is dedicated to improving patient care and reducing the cost of
care by helping clinicians effectively treat patients faster than
ever before. T2 Biosystems’ products include the T2Dx® Instrument,
T2Candida® Panel, and T2Bacteria® Panel and are powered by the
proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems
has an active pipeline of future products, including products for
the detection of additional species and antibiotic resistance
markers of sepsis pathogens, and tests for Lyme disease.
Media Contact: Gina Kent, Vault
Communicationsgkent@vaultcommunications.com 610-455-2763
Investor Contact: Zack Kubow, W2O
Groupzkubow@w2ogroup.com 415-658-6436
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