T2 Biosystems Announces New T2Bacteria RUO Panel Data Presented at AMP 2017

Results Show Detection of Clinically Important Infections Missed by Blood Culture

LEXINGTON, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the development of innovative diagnostic products for critical unmet needs in healthcare, today announced new data presented on the T2Sepsis Solution™ during the Association for Molecular Pathology (AMP) 2017 Conference in Salt Lake City, UT. These data highlight the potential clinical value that may be achieved using the T2Bacteria® Panel compared to results from blood culture.

Chiagozie Ononye, M.D. of Northwestern University’s Feinberg School of Medicine presented data from 61 patient samples that were tested using the T2Bacteria for Research Use Only (RUO) Panel. The retrospective study compared T2Bacteria results both to blood culture results and to the case history of each patient to determine the accuracy and potential impact of the T2Bacteria Panel for patient care. The analysis concluded that the T2Bacteria RUO Panel:

  • Detected true, confirmed bacterial infections better than blood culture.
  • Identified 72% of infections, a higher rate than any other method in the study, including blood culture, which only identified 40% of cases.
  • Identified 9 infections confirmed by other methods that were not identified by blood culture.
  • Distinguished ineffectively treated infections from those that could be contained and cured in cases that were not identified by blood culture.

Dr. Ononye posited that an early result from the T2Bacteria Panel could enable clinicians to treat the source of infection and begin targeted antimicrobial therapy far earlier in the clinical care pathway, which are the most effective methods to improve patient outcomes. Today, the T2Bacteria Panel is CE Marked and commercially available in Europe, and is currently under review by the Food and Drug Administration (FDA) for market clearance in the United States.

“At Northwestern, we are particularly interested in exploring the added clinical value from T2Bacteria and T2Candida Panel results. In our retrospective study, the T2Sepsis Solution correctly identified the causative pathogen in infected patients where blood culture was negative,” said Dr. Ononye. “If confirmed in prospective trials, getting these clinically relevant results in 3 to 5 hours offers an opportunity to improve patient outcomes and the quality of patient care.”

The T2Bacteria Panel is a part of the T2Sepsis Solution, a unique approach to the overall care of patients who have or might develop sepsis. These newly reported data add to the many studies that have proven the excellent clinical performance of the T2Sepsis Solution due to these important characteristics:

  • Time to result 40x faster than blood culture based methods.
  • Clinical sensitivity in the range of 90-100% as shown in more than 300 cases across several studies of known infected patients compared to the reported 50-65% sensitivity of blood culture.
  • Clinical specificity on average of approximately 98% across over 3,000 patients tested at 15 institutions.

“I am very pleased that studies conducted by hospital users continue to demonstrate that the T2Bacteria RUO Panel test results are strongly indicative of true infections in patients with negative blood cultures,” said Tom Lowery, Ph.D., chief scientific officer of T2 Biosystems. “This and other studies have shown that the T2Sepsis Solution is detecting infections for which early and sensitive identification can lead to faster time to appropriate treatment – for example, infections in the lungs where it is likely to start to spread throughout the body. In a case like this, T2Bacteria should help physicians get patients on a targeted therapy faster.”

Videos of the full presentations by Dr. Ononye and Dr. Lowery are available here.

About T2 Biosystems
T2 Biosystems, a leader in the field of innovative in vitro diagnostics that solves critical unmet needs in healthcare, improves patient care and reduces the cost of healthcare by helping clinicians effectively treat patients faster than ever before. For more information, please visit www.t2biosystems.com.

About the T2Sepsis Solution
Sepsis, one of the deadliest and most expensive conditions in hospitals today, is the focus of the T2Sepsis Solution, 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. Powered by the proprietary T2 Magnetic Resonance technology, or T2MR®, the T2Sepsis Solution is proven to deliver better patient care and greater cost savings. It 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. T2Bacteria Panel is commercially available in Europe and other countries that accept the CE Mark and is available for research use only in the U.S.

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

Media Contact:
Amy Phillips, Feinstein Kean Healthcare

Investor Contact:
Chris Brinzey, Westwicke Partners

T2 Biosystems, Inc.

TW Research's Disclaimers & Disclosures: TW Research may have been compensated for writing this article. For a full list of disclaimers and disclosures, please visit http://tailwindsresearch.com/disclaimer/.


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