Superinfection

LEXINGTON, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- 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

A new international study has shown mpox (formerly known as monkeypox) infections to be less severe among those who are vaccinated or had a previous infection in 2022, underlining the importance and effectiveness of vaccination. A new international study led by Queen Mary University of London has shown mpox (formerly known as monkeypox) infections to be less severe among those who are vaccinated or had a previous infection in 2022, underlining the importance and effectiveness of vaccination. The research, published in The Lancet Infectious Diseases, was delivered by the SHARE-net collaborative and looked at 38 mpox infections in 37 gay and bisexual men. Eight of the 38 were reinfections, and 30 infections occurred after a complete vaccination course. In the people who had been vaccinated, the results showed that the patients had fewer lesions (abnormal tissue such as a wound or rash), less mucosal disease (diseases of the mucous membranes of the mouth and genitals), and a minimal need for pain medication or hospitalisation. The severity of symptoms was observed and assessed using the Mpox-SSS score, which was developed during the 2022 multi-country outbreak. The Mpox-SSS score is a numerical score given considering seven different factors including the number of lesions, the level of care required for the patient, the amount of pain medication needed, the extent of mucosal areas affected, and whether there is any bacterial superinfection -- i.e., additional infections. Using this scoring system it was possible to demonstrate and measure severity. In those who had been reinfected, the disease was less severe with a lesser requirement for pain medication compared to their first bout, and fewer areas of the body were affected while recovery was also faster. The first infection lasted 21 days (median) whereas the second infection lasted 15 days (median). The study is the largest and only case series to examine both reinfections and infections after a complete vaccine course of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN). Since May 2022, there have been more than 87,000 cases of human mpox across 112 countries. Transmissions have primarily affected sexually active gay and bisexual men and been caused by skin-to-skin and bodily fluid contact. As evidenced by the two previous SHARE-net global case series published in The NEJM and The Lancet, infection often causes rashes, fevers, and blisters. It can also lead to brain inflammation and seizures. In people with advanced HIV disease, it carries a mortality of up to 27% in the most immunosuppressed group. Neither natural immunity from a prior mpox infection nor post-vaccination immunity can prevent someone from getting the virus. However, the study shows that the immunity from both reduces severity. Research lead author Chloe Orkin, Professor of HIV Medicine at Queen Mary University of London and Director of the SHARE collaborative, said: "This is good news and shows that post-vaccination infections are less severe and the need for hospitalisation is lower. This is clear evidence that vaccination is an important tool in reducing morbidity and controlling further outbreaks. "We have to ensure global access to vaccinations and treatments if we want to curb this global outbreak, especially in the African regions that have been historically worst affected and are still without access to vaccines or treatment for mpox."

Studies demonstrate that T2Bacteria and T2Candida panels enable sensitive and specific diagnosis to enhance the standard of careLEXINGTON, Mass., Oct. 14, 2022 (GLOBE NEWSWIRE) -- 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