TTOO T2 Biosystems Inc

T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, announced today the publication of two independent, peer-reviewed studies highlighting the potential of the T2Bacteria and T2Candida Panels to improve outcomes and be cost-effective for a wide range of clinical scenarios. The most recent study, titled “Cost-effectiveness of molecular diagnostic assays for the therapy of severe sepsis and septic shock in the emergency department,” was published in the online journal PLOS ONE. This follows another study titled “Cost-effectiveness of rapid diagnostic assays that perform directly on blood samples for the diagnosis of septic shock” that was published in the journal Diagnostic Microbiology and Infectious Disease.  

These studies examined the cost-effectiveness of using two blood culture sets in conjunction with rapid molecular diagnostic assays, including the direct-from-blood T2Bacteria and T2Candida Panels, which are the only U.S. Food and Drug Administration (FDA) cleared diagnostic tests that detect the species-specific pathogens associated with sepsis (“bundle approach”), versus the use of two sets of blood cultures only, for patients presenting in the Emergency Department or the medical Intensive Care Unit (ICU) with severe sepsis or septic shock. The studies concluded that:

• The bundle approach provided more effective antibiotic therapy than blood culture alone.
• The bundle approach was cost effective as compared to blood culture alone, when considering cost savings for deaths averted by a direct-from-sample molecular diagnostic test.
• The effectiveness of the bundle approach is expected to maximize when used at time of presentation of septic patients to the Emergency Department and in hospital settings with high prevalence of drug resistant pathogens and high rates of inappropriate empiric antibiotic therapy.

“This study provides a detailed analysis of the potential clinical and cost-savings benefits of implementing rapid molecular diagnostics assays of which the T2Bacteria and T2Candida Panels are the only FDA-cleared products in the market, in patients with severe sepsis or septic shock in the medical ICU and emergency department,” said John McDonough, president and chief executive officer. “This is aligned with the real-world results reported by our customers, which includes actionable results in as little as 3-5 hours, allowing for appropriate adjustment of antibiotic therapy, or de-escalation of therapy in patients with a negative result. This rapid result uniquely provided by our products and benefits patient care can lead to cost-savings and supports improved antimicrobial stewardship.”

The cost-effectiveness conclusions from the study align with the real-world results reported by T2 customers. This utilization also includes patients that present in the hospital with symptoms of a blood stream infection (BSI) but are not in severe sepsis or septic shock. The T2Bacteria and T2Candida Panels provide rapid diagnostic results for these patients, allowing clinicians to ensure that their patients are on effective antimicrobial therapy in order to optimize outcomes. These improved clinical outcomes also have the potential to significantly improve cost savings as has been independently demonstrated by many T2 customers.

The corresponding author of the studies is Eleftherios Mylonakis, of the Infectious Diseases Division, Warren Alpert Medical School of Brown University, Rhode Island Hospital.

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, 2018, filed with the U.S. Securities and Exchange Commission, or SEC, on March 14, 2019, 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 Communicationsgkent@vaultcommunications.com 610-455-2763

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