T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced participation in the NIH-funded Antibacterial Resistance Leadership Group (ARLG) pilot study for pneumonia patients. The Pneumonia Direct Pilot study is a prospective, observational, diagnostic, feasibility study to determine the accuracy of multiple pathogen- and host-directed tests for the diagnosis of ventilator-associated pneumonia (VAP). Under the direction of Kimberly Hanson, M.D., University of Utah, the study seeks to explore new approaches for diagnosing VAP along with more comprehensive detection of antibiotic-resistant infections. The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen and host-directed testing approaches.

“I am elated that the innovative research leaders of Antibacterial Resistance Leadership Group are collaborating with T2 Biosystems to evaluate direct-from-blood diagnostic technology for the management of patients with pneumonia. This study will explore whether the combined diagnostic testing can successfully provide more targeted antimicrobial therapy, strengthen stewardship, and improve outcomes,” said Dr. Thomas J. Walsh, Director of the Center for Innovative Therapeutics and Diagnostics (citdx.org) and member of the T2 Biosystems Scientific Advisory Board.

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 Johns Hopkins Medicine laboratories.

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 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, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Biothreat™ Panel, the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. 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 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 December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, 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.

Research discussed in this publication is supported in part by the ARLG Grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. For more information about this trial, visit ClinicalTrials.gov and search identifiers NCT NCT06181669.

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. May 2020;46(5):888-906. doi:10.1007/s00134-020-05980-0

3 Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. Oct 2005;33(10):2184-93. doi:10.1097/01.ccm.0000181731.53912.d9

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. Mar 2008;23(1):91-100. doi:10.1016/j.jcrc.2007.08.007

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. Apr 11 2007;297(14):1583-93. doi:10.1001/jama.297.14.1583

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: Philip Trip Taylor, Gilmartin Group ir@T2Biosystems.com 415-937-5406

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