T2 Biosystems Release: Study Published In Journal Of Antimicrobial Stewardship Shows Patients Diagnosed With T2Candida Panel Treated More Than Eight Times Faster

Published: Oct 03, 2017

- T2MR platform shown to lead to appropriate therapy in 5 hours compared to 44 hours based on blood culture

LEXINGTON, Mass., Oct. 03, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced that Henry Ford Health System published the clinical impact of the T2Candida Panel in The Journal of Antimicrobial Stewardship. The study, titled “T2 Magnetic Resonance Assay Improves Timely Management of Candidemia,” compared the management of candidemic patients before and after the implementation of the T2Candida Panel and was designed to evaluate time to appropriate therapy. Patients tested with the T2 Magnetic Resonance (T2MR) platform were treated in a median of 5 hours, a more than 8-fold reduction as compared to that based on blood culture, which delayed appropriate therapy by a median of 44 hours. This speed advantage demonstrates that the T2MR platform is a valuable clinical tool to aid antifungal stewardship’s goal to deliver timely antifungal therapy for infected patients.

“This technology has shown it can expedite the detection of candidemia,” said Henry Ford study co-author Rachel Kenney, PharmD. “As a result, patients receive more prompt and appropriate antifungal therapy.”

In addition to speed, the use of the T2MR platform provided increased certainty to the identification of Candida infections. Consistent with the performance of blood culture and T2MR published in other studies, the Candida species was definitively identified in 93% of patients after implementation of T2MR and in only 57% of patients prior to implementation of T2MR. Prior to implementation of the T2Candida Panel, the only diagnostic tests used at Henry Ford were blood culture and beta-D-glucan (BDG).

“In our inaugural publication, we are excited to highlight innovative work done by antimicrobial stewardship clinicians to provide optimal care to their patients and be better stewards of antimicrobials,” said Eric Wenzler, PharmD, editor of the Journal of Antimicrobial Stewardship. “Henry Ford’s use of the T2Candida assay to significantly reduce time to appropriate antifungal therapy is an important advance in rapid diagnostics, patient care, and antifungal stewardship.”

The authors also identified an additional clinically relevant improvement in patient outcomes after the implementation of T2MR: a significant reduction of Candida ocular involvement from 30% to 12% was observed. The authors point out this could be associated with improved sensitivity of T2MR or due to improved timeliness of patient management by T2MR.

Although the study was not adequately powered to evaluate reduction in patient mortality rates, the authors note that appropriately treating patients within 24 hours of the onset of disease is proven to reduce mortality rates from 41% to below 16%. T2MR is the only diagnostic method presented in this study with the speed and accuracy necessary to enable therapeutic decisions that achieve this reduction in mortality.

“I expected that T2MR platform’s direct-from-whole-blood technology would be the biggest breakthrough in candidemia management in decades and these clinical data demonstrate the promise of culture independent diagnostics,” said Michael A. Pfaller, M.D., Emeritus Professor, University of Iowa and Clinical Advisor, T2 Biosystems. “The T2MR platform is improving patient care, antimicrobial stewardship, and hospital finances today - and the positive impact for hospitals should only grow as new tests become commercially available.”

The Journal of Antimicrobial Stewardship paper was published online at: http://www.jantimicrobialstewardship.org/issues/.

About the sepsis-causing pathogen Candida
Candida is one of the deadliest sepsis-causing pathogens with a startling mortality rate of approximately 40% among patients receiving current standard of care. It is one of the leading hospital-acquired bloodstream infections in the United States and half of Candida infections are misdiagnosed as being negative by blood culture. The patient and economic impacts of Candida are tremendous: patients average 40 days in the hospital at a cost of $130,000 each.

About T2 Biosystems
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, is dedicated to saving lives and reducing the cost of healthcare by empowering clinicians to effectively treat patients faster than ever before. T2 Biosystems is focused on addressing critical unmet needs in healthcare starting with sepsis, one of the deadliest and most expensive conditions in hospitals today. The T2Sepsis SolutionTM is a unique approach that combines the standard of care for the management of sepsis patients with T2 Biosystems’ products, including the T2Dx® Instrument and T2Candida® Panel, and the T2Bacteria® Panel, which is commercially available in Europe and other countries that accept the CE Mark and available for research use only in the U.S. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. Hospital customer experience has demonstrated faster time to effective treatment, shortened ICU and hospital lengths of stay, reduced use of unnecessary antifungals, and millions of dollars in savings. T2 Biosystems has an active pipeline of future sepsis products including additional species and antibiotic resistance, as well as tests for Lyme disease and hemostasis. For more information, please visit www.t2biosystems.com.

About the Journal of Antimicrobial Stewardship
The Journal of Antimicrobial Stewardship (JAMS) is the only exclusive journal devoted to the advancement of antimicrobial stewardship. The open-access journal publishes quarterly peer-reviewed articles on a variety of topics that pertain to antimicrobial stewardship including clinical microbiology, rapid diagnostic tests, pharmacoeconomics, disease state-based stewardship interventions and the evaluation of current and novel therapies that promote optimal infectious diseases practices in a variety of settings and institutions. JAMS publishes high-quality original research articles, review articles, editorial commentaries, and challenging patient scenarios. The aim of the Journal of Antimicrobial Stewardship is to provide timely, informative and innovative research articles on topics related to antimicrobial stewardship and infectious diseases pharmacotherapy. The goal of the Journal is to catalyze the change required to improve patient outcomes through the promotion of optimal antimicrobial stewardship practices. For more information about the Journal, please visit jantimicrobialstewardship.org or follow @JAMS_journal on Twitter. To register as an author and/or reviewer, visit the JAMS editorial manager at ojs.jantimicrobialstewardship.org. For any inquires, contact the Journal at editor@jantimicrobialstewardship.org.

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 regarding , product pipeline, anticipated product benefits, goals and strategic priorities, product expansion or opportunities, growth expectations or targets and FDA clearance, 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, 2016, filed with the U.S. Securities and Exchange Commission, or SEC, on March 15, 2017, 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, one should not 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.

Company Contact:
Darlene Deptula-Hicks, T2 Biosystems
SVP & Chief Financial Officer
ddeptula@t2biosystems.com
603-553-5803

Media Contact:
Amy Phillips, Feinstein Kean Healthcare
amy.phillips@fkhealth.com
412-327-9499

Investor Contact:
Chris Brinzey, Westwicke Partners
chris.brinzey@westwicke.com
339-970-2843

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