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T2 Biosystems Awarded Up To $2 Million by CARB-X to Support Development of New Tests on the T2Dx Instrument for Drug-Resistant Bacteria
New tests aim to expand T2Dx Instrument product line by detecting 20 additional bacterial species and resistance targets that could empower doctors to rapidly treat more patients with targeted therapy

LEXINGTON, Mass., March 06, 2018 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, announced today that it has been awarded a grant of up to $2 million from CARB-X. The collaboration with CARB-X will be used to accelerate the development of new tests to identify bacterial pathogens and resistance markers directly in whole blood much more rapidly than is possible using today's diagnostic tools. The new tests aim to expand the T2Dx Instrument product line by detecting 20 additional bacterial species and resistance targets, with a focus on blood borne pathogens on the CDC antibiotic resistance threat list.

"The ability to rapidly diagnose and treat drug-resistant bacteria will save lives by enabling doctors to treat patients more quickly and effectively than is possible with today's diagnostic tools," said Kevin Outterson, Executive Director of CARB-X. "Our collaboration with T2 Biosystems enhances the diversity of our pipeline with exciting technology. These products are not ready for use in patients yet, but if approved, they offer great potential to fight against life-threatening, drug-resistant bacteria."

CARB-X's mission is to drive antibacterial innovation and combat the growing threat of antimicrobial resistance. It is jointly led by BARDA, a government agency at the U.S. Health and Human Services, and the Wellcome Trust, a global charitable foundation based in the U.K. Through this grant, T2 Biosystems will receive an initial award of up to $1.1 million, with the possibility of up to $0.9 million more based on the achievement of certain project milestones.   

"The collaboration with CARB-X will accelerate the development of diagnostic tests to identify major bacterial species and resistance genes faster than ever," said John McDonough, president and chief executive officer of T2 Biosystems. "Identifying these infections directly from whole blood with T2MR technology will help patients receive the right therapy faster – improving patient outcomes and reducing healthcare costs. We believe these diagnostic advances will also support the development of new antibiotics by accelerating clinical trials, attacking the problem of resistance on all fronts."

Rapid diagnosis means better and faster treatment with fewer deaths

Bacterial bloodstream infections can be deadly even at low concentrations. If bacterial infections are identified quickly, patients can be placed on effective antibiotic therapy faster. The T2 Biosystems collaboration builds on T2 Biosystems' T2MR technology and FDA-cleared T2Dx Instrument, focusing on the development of new tests that will identify bacterial pathogens and resistance markers directly in whole blood. Existing diagnostics rely primarily on blood cultures conducted in laboratories, which can take days and do not always produce reliable results. As a result, physicians are often unable to place patients on targeted antibiotic therapy quickly, leading to higher mortality and overuse of unnecessary antibiotics.

The new tests aim to address the most serious superbugs and resistance genes on the antibiotic-resistance threat list published by the Centers for Disease Control and Prevention (CDC). The tests delivered by T2 Biosystems with support from CARB-X will aim to identify 20 additional infectious species and resistance genes directly from whole blood, including Carbapenem-resistant Enterobacteriaceae (CRE) and Methicillin-resistant Staphylococcus aureus (MRSA). In total, T2 Biosystems aims for the tests to detect over 25 targets for bacterial species and resistance markers. 

In addition to speeding diagnosis and treatment of patients, these tests could be used to accelerate clinical trials for new antibiotics and reduce their time to market.

About T2 Biosystems:
T2 Biosystems, an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, 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 Solution™ 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

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 regarding uptake or adoption of products, future aspects and anticipated benefits of the collaboration with CARB-X, additional patients, timing of testing patients, anticipated product benefits or access, strategic priorities, product expansion or opportunities, growth expectations or targets and timing or occurrence of FDA filings or clearances or commercial releases. 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; (iv) reliance on third parties; (v) competitive factors; (vi) manufacturing or supply disruptions; (v) regulatory factors; (vi) risks related to intellectual property; or (vii) 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, it disclaims any obligation to do so, even if subsequent events cause its views to change. 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.

About CARB-X
CARB-X is one of the world's largest public-private partnership devoted to early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI).

This press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health or Wellcome Trust.

CARB-X Background
CARB-X was created in response to the US government's 2015 National Action Plan for Combating Antibiotic Resistant Bacteria (CARB) and the UK government's call in 2016 for a concerted global effort to tackle antibiotic resistance. A non-profit partnership, it is headquartered at Boston University. CARB-X was launched by the US Department of Health and Human Services (HHS)'s Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID/NIH). Funders are BARDA and Wellcome Trust. NIAID provides preclinical services support. Other partners include the Broad Institute of MIT and Harvard, the Massachusetts Biotechnology Council (MassBio), the California Life Sciences Institute (CLSI), and RTI International. CARB-X projects are selected through a global competitive process. Applications are vetted by the CARB-X Science Advisory Board. To be considered, projects must target one of the antibiotic resistant bacteria on the Serious or Urgent Threat List prepared by the CDC or on the Priority Pathogens list published by the WHO.

T2 Biosystems Media Contact:
Amy Phillips, Feinstein Kean Healthcare

T2 Biosystems Investor Contact:
Chris Brinzey, Westwicke Partners

CARB-X Media Contact:
Jennifer Robinson

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