T2 Biosystems Announces Participation in NIH-funded Antibacterial Resistance Leadership Group (ARLG) Pilot Study for Pneumonia Patients
“I am elated that the innovative research leaders of
In the pilot study, the FDA-cleared T2Bacteria® Panel and the T2Resistance® Panel, included as one of the pathogen directed platforms, will be evaluated for the ability to rapidly detect infections in the blood currently missed by conventional methods. The T2 sample testing for the multi-center study will be performed at
The extremely low level of detection by T2 Biosystems’ technology (“T2MR”) in whole blood (1 – 11 CFU/mL) has been effective in detecting secondary infections. Most recently, a 2022 publication1 in the journal Microbiology Spectrum evaluated the use of T2 Biosystems’ sepsis tests in COVID-19 patients and found “without the additional use of T2MR, 13.3% of candidemia and 10% of bacterial superinfections would have been missed.”
About Ventilator-associated pneumonia (VAP)
Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections complicating critical care medicine. Recent studies have reported that VAP affects between 5-40% of patients intubated for more than 2 days, with significant variation by county, intensive care unit (ICU), and criteria used to define the disease2. Patients who develop VAP have prolonged durations of mechanical ventilation, increased lengths of ICU stay, and higher hospital costs3. Poor outcomes are due, at least in part, to difficulties in making a diagnosis of VAP, which in turn delays the initiation of appropriate antibiotic therapy4. The clinical criteria suggestive of VAP are non-specific and standard microbiologic testing does not definitively separate airway colonizers from invasive pathogens. The resultant diagnostic uncertainty is a major driver of unnecessary antibiotic use and potentially antimicrobial resistance in the ICU5,6. Furthermore, selecting effective empiric therapy for VAP is also complicated because multidrug-resistant pathogens may be isolated in early-onset VAP (i.e., within the first 4 days of hospitalization) as well as in late-onset cases7.
About T2 Biosystems
Forward-Looking Statements
This 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 about the ability of the Company’s product to provide more targeted antimicrobial therapy, strengthen stewardship, and improve outcomes, 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
Research discussed in this publication is supported in part by the ARLG Grant from the
References:
1 Seitz T, Holbik J, Hind J, Gibas G, Karolyi M, Pawelka E, Traugott M, Wenisch C, Zoufaly A. Rapid Detection of Bacterial and Fungal Pathogens Using the T2MR versus Blood Culture in Patients with Severe COVID-19. Microbiol Spectr. 2022 Jun 29;10(3):e0014022. doi: 10.1128/spectrum.00140-22. Epub 2022 Jun 13. PMID: 35695564; PMCID: PMC9241933.
2 Papazian L, Klompas M, Luyt CE. Ventilator-associated pneumonia in adults: a narrative review. Intensive Care Med.
3 Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review.
4 Kuti EL, Patel AA, Coleman CI. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: a meta-analysis. Journal of critical care.
5 Nussenblatt V, Avdic E, Berenholtz S, et al. Ventilator-Associated Pneumonia: Overdiagnosis and Treatment Are Common in Medical and Surgical Intensive Care Units. Infection Control & Hospital Epidemiology. 2014;35(3):278-284. doi:10.1086/675279
6 Klompas M. Does this patient have ventilator-associated pneumonia? Jama.
7 Khan S, Liu J, Xue M. Transmission of SARS-CoV-2, Required Developments in Research and Associated Public Health Concerns. Front Med (Lausanne). 2020;7:310. doi:10.3389/fmed.2020.00310
Investor Contact:
ir@T2Biosystems.com
415-937-5406
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Source: T2 Biosystems, Inc.