LEXINGTON, Mass., Feb. 27, 2019 (GLOBE NEWSWIRE) -- The FDA has granted T2 Biosystems, Inc. (NASDAQ:TTOO) “Breakthrough Device” designation for the T2Resistance Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample, without the wait for blood culture.

The 13 genes identified on the panel include the most clinically important, as they are largely resistant to antimicrobial drugs that for certain patients, are crucial in the treatment of bacterial infections, including carbapenems, vancomycin, penicillin and more. Several of the genes detected by the panel are listed on the CDC’s Urgent Threat list for antibiotic resistance.

The Breakthrough Designation allows T2 Biosystems to work closely with the FDA during the premarket review phase to ensure patients can have access to the benefits of this innovation as soon as possible.

“Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient. These conventional methods, including blood cultures and antimicrobial susceptibility testing (AST), take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need,” said Sandy Estrada, PharmD, vice president, medical affairs at T2 Biosystems and president of Florida Health-System Pharmacists (FSHP) organization.

The T2Resistance™ Panel—which is expected to be available for research use only (RUO) in the U.S. and receive CE Mark for commercial availability in Europe later this year— can provide results in 3 to 5 hours, directly from a blood sample. This technology does not require a positive blood culture, thus eliminating days from the diagnostic process and therefore expediting accurate, targeted treatment for certain antibiotic resistant bloodstream infections. As a result, the panel, similar to the T2Bacteria and T2Candida panels, can help combat the consequences associated with overprescribing unnecessary antimicrobial drugs, allowing clinicians to potentially save more patient lives, cut hospitalization costs and reduce the unnecessary use of antimicrobial drugs—the primary cause of resistance.

“We’re grateful to the FDA for bringing us one step closer to getting the T2Resistance™ Panel in the hands of clinicians across the country,” said John McDonough, president and chief executive officer of T2 Biosystems. “With the introduction of this panel, the T2 product portfolio will continue to expand to enable clinicians to make fast, accurate treatment decisions for the more than 2 million people who get an antibiotic-resistant infection each year in the United States alone.”

The T2Resistance™ panel utilizes the same T2Dx® Instrument as the T2Bacteria® and T2Candida® Panels – the first and only FDA-cleared panels for direct detection of sepsis-causing pathogens from whole blood samples, which enable clinicians to start swift, targeted treatment for their patients. T2Resistance™ panel has been developed with the help of an award from CARB-X, funded by the Biomedical Advanced Research and Development Authority (BARDA), a government agency at the U.S. Department of Health and Human Services; the Wellcome Trust, a global charitable foundation based in the U.K.; with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). T2 Biosystems owns exclusive worldwide distribution and intellectual property rights to the T2Resistance™ Panel.

About T2 Biosystems
T2 Biosystems, a leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, 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, T2Candida® Panel, and T2Bacteria® Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including products for the detection of additional species and antibiotic resistance markers of sepsis pathogens, and tests for Lyme disease. 

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 additional patients, timing of testing patients, anticipated product benefits, strategic priorities, product expansion or opportunities, growth expectations or targets, timing of FDA filings or clearances and anticipated operating expenses, 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, 2017, filed with the U.S. Securities and Exchange Commission, or SEC, on March 19, 2018, 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.

Media Contact:
Gina Kent, Vault Communications
gkent@vaultcommunications.com
610-455-2763

Investor Contact:
Zack Kubow, W2O Group
zkubow@w2ogroup.com
415-658-6436

Research reported in this news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.