T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, announced today the publication of three new, peer-reviewed
studies that demonstrate the clinical value of the use of the T2
Biosystems’ products, also referred to as T2 Magnetic Resonance
Technology (T2MR®). T2 Biosystems’ sepsis products are CE marked,
and include the only FDA cleared products able to quickly and
accurately detect sepsis-causing pathogens within adult patient
blood samples without the need to wait hours for a positive blood
culture. The studies were conducted in Europe and published in the
Journal of Clinical Microbiology, Microbiology Spectrum and the
Journal of Fungi.
“We are pleased with the growing number of
publications with clinical evidence supporting the value
proposition of our sepsis panels. Given the mounting evidence of
additional clinical utility, we are exploring expansion of product
claims through future regulatory submissions,” stated John Sperzel,
Chairman and CEO of T2 Biosystems. “The growing awareness of the
benefits of our technology can help T2 Biosystems positively impact
the lives of more patients, advance the standard of care, and drive
continued product adoption.”
Study Highlights
Combining T2Bacteria and T2Candida
Panels for Diagnosing Intra-Abdominal Infections: A Prospective
Multicenter Study (2022)Authors: Anders
Krifors, Måns Ullberg, Markus Castegren, Johan Petersson, Ernesto
Sparrelid, Volkan Özenci and Ola BlennowJournal:
Journal of Fungi 2022, 8, 832A study conducted at the Karolinska
University Hospital in Stockholm, Sweden, that combined T2Bacteria
and T2Candida to diagnose Intra-Abdominal Infection (IAI) in
surgical patients admitted to the ICU or high dependency unit
found:
- Ability to detect more infections:
T2Bacteria and T2Candida detected more clinically confirmed cases
of IAI than blood culture.
- Faster Targeted Therapy: 15% of
blood culture negative and T2Bacteria positive cases were receiving
inappropriate antimicrobial therapy at the time of sampling.
- Fast and accurate detections:
T2Bacteria and T2Candida were fast and accurate in diagnosing
on-panel bloodstream infections and were able to detect
culture-negative IAI and intra-abdominal candidiasis (IAC).
Effective Rapid Diagnosis of Bacterial
and Fungal Bloodstream Infections by T2 Magnetic Resonance
Technology in the Pediatric Population
(2022)Authors: B. Lucignano, V. Cento, M.
Agosta, F. Ambrogi, S. Albitar-Nehme, L. Mancinelli, G. Mattana, M.
Onori, F. Galaverna, L. Di Chiara, T. Fragasso, R. Bianchi, F.
Tortora, C. Auriti, A. Dotta, C. Cecchetti, S. Perdichizzi, M.
Raponi, A. Onetti Muda, S. Nerini Molteni, A. Villani, F.
Locatelli, C. Federico Perno, P.
BernaschiaJournal: American Society for
Microbiology, Journal of Clinical MicrobiologyA 754 patient
retrospective research study conducted at the Bambino Gesù hospital
in Rome, Italy, that analyzed the diagnosis of bacterial and fungal
bloodstream infections in the pediatric population found:
- Faster Targeted Therapy: Patients
suspected of bacterial or fungal bloodstream infections that were
tested with T2Bacteria or T2Candida received targeted therapy 61.3
hours or 121.8 hours faster compared to blood culture,
respectively.
- Higher Detection Rate: T2Bacteria
and T2Candida detected 79 additional probable or possible bacterial
bloodstream infections and 6 additional probable or possible fungal
bloodstream infections in pediatric patients that were missed by
blood culture.
Rapid Detection of Bacterial and Fungal
Pathogens Using the T2MR versus Blood Culture in Patients with
Severe COVID-19 (2022)Authors: Tamara
Seitz, Johannes Holbik, Julian Hind, Georg Gibas, Mario Karolyi,
Erich Pawelka, Marianna Traugott, Christoph Wenisch, Alexander
ZoufalyaJournal: Microbiology SpectrumA study
conducted at the Klink Favoriten hospital in Vienna, Austria,
reported several highlights regarding usage of T2 Biosystems’
products to detect COVID-19 superinfections in ICU patients.
- Faster Targeted Therapy: The median
time to therapy change with T2 panels was more than 52 hours faster
compared to blood culture. The authors noted “without the
additional use of T2MR, 13.3% of candidemia and 10% of bacterial
superinfections would have been missed.”
- Faster Time to Detection: Positive
results for COVID-19 with T2Bacteria were available in 4.3 hours,
compared to a mean time of 41.5 hours for the standard of care.
Positive results for COVID-19 with T2Candida were available in 5
hours compared to a mean time of 85.6 hours for the standard of
care. A negative result for T2MR was available in 4.7 hours
compared to a mean time of 177.3 hours for the standard of
care.
- Sensitivity and Specificity: T2
Biosystems’ products detected 100% of species on the panel.
- Impact on Infections: T2 Panel
targets covered and detected 71.4% of all pathogens causing
infection.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, 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, T2Bacteria®
Panel, T2Candida® Panel, T2Resistance® Panel, and T2SARS-CoV-2™
Panel and are powered by the Company’s proprietary T2 Magnetic
Resonance (T2MR®) technology. T2 Biosystems has an active pipeline
of future products, including the T2Cauris™ Panel, T2Lyme™ Panel,
as well as additional products for the detection of bacterial and
fungal pathogens and associated antimicrobial resistance markers,
and biothreat pathogens. For more information, please visit
www.t2biosystems.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including, without limitation, statements regarding the
value proposition of T2 Biosystems’ products, the benefits of T2
Biosystems’ technology, or the impact that growing awareness of the
technology can have on the lives of patients, the standard of care,
and product adoption, as well as statements that include the words
“expect,” “intend,” “plan”, “believe”, “project”, “forecast”,
“estimate,” “may,” “should,” “anticipate,” and similar statements
of a future or forward looking nature. These forward-looking
statements are based on management’s current expectations. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, (i) any inability to (a)
realize anticipated benefits from commitments, contracts or
products; (b) successfully execute strategic priorities; (c) bring
products to market; (d) expand product usage or adoption; (e)
obtain customer testimonials; (f) accurately predict growth
assumptions; (g) realize anticipated revenues; (h) incur expected
levels of operating expenses; or (i) increase the number of
high-risk patients at customer facilities; (ii) failure of early
data to predict eventual outcomes; (iii) failure to make or obtain
anticipated FDA filings or clearances within expected time frames
or at all; or (iv) the factors discussed under Item 1A. “Risk
Factors” in the company’s Annual Report on Form 10-K for the year
ended December 31, 2021, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 23, 2022, and other filings
the company makes with the SEC from time to time. These and other
important factors could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
the company may elect to update such forward-looking statements at
some point in the future, unless required by law, it disclaims any
obligation to do so, even if subsequent events cause its views to
change. Thus, no one should assume that the Company’s silence over
time means that actual events are bearing out as expressed or
implied in such forward-looking statements. These forward-looking
statements should not be relied upon as representing the company’s
views as of any date subsequent to the date of this press
release.
Investor Contact:Philip Trip
Taylor, Gilmartin Groupir@T2Biosystems.com 415-937-5406
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