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(June 13, 2018)
LEXINGTON, Mass., June 13, 2018 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products for critical unmet needs in healthcare, announced today late-breaker posters and data presented at the American Society for Microbiology (ASM) Microbe conference on June 7-11 that demonstrate the T2Bacteria® Panel’s accuracy and speed, which may enable more rapid treatment of patients with bloodstream infections in order to prevent sepsis. FDA clearance of the T2Bacteria Panel was announced on May 29, 2018, making the T2Bacteria Panel the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood.
“The strong customer data and conclusions expressed by clinicians at ASM Microbe on T2Bacteria are encouraging and allows us to further strengthen the momentum generated by FDA clearance two weeks ago,” said John McDonough, president and chief executive officer, T2 Biosystems. “We are already seeing excitement in the market, as healthcare providers recognize the potential of the T2Bacteria Panel to prevent the progression of bloodstream infections to sepsis. The ASM Microbe conference, which is one of our largest customer meetings of the year, was an important and successful step to raise awareness around the T2Bacteria Panel.”
For the first time in the U.S., the T2Bacteria pivotal clinical trial data was presented, representing a large study of over 1,400 patient samples collected across 11 hospital and hospital systems across the U.S. The investigators concluded:
- T2Bacteria demonstrated excellent accuracy, including overall sensitivity of 90% and overall average specificity of 98%.
- T2Bacteria detected 69 patient infections that were not detected by the concurrent blood culture.
- Blood culture species identification results took an average of 3 days while T2Bacteria took an average of only 5.4 hours in the clinical trial, providing results more than 2.5 days faster.
- 66% of patients in the clinical trial with a bloodstream infection confirmed by T2 and blood culture could have benefited from earlier appropriate antibiotics based on the rapid T2Bacteria result.
- T2Bacteria also had a noted advantage in detecting infected patients on antibiotics who were missed by blood culture.
“T2 panels afford clinicians the first direct from blood diagnostics for the detection of sepsis-causing pathogens,” said clinical trial investigator Cornelius J. Clancy, MD, Associate Professor of Medicine, Infectious Diseases Division and Director, Mycology Program, University of Pittsburgh; Chief of Infectious Diseases Section, VA Pittsburgh Health Care System. “Earlier species ID results from T2Bacteria and T2Candida provide critical and timely information that can aid in providing the best care for my patients. The T2Bacteria pivotal clinical trial data corroborate findings from the T2Candida Direct2 study by demonstrating the limitations of blood culture and the potential impact of the T2 platform.”
A separate evaluation of T2Bacteria by clinicians at Ochsner Medical Center found:
- T2Bacteria detected 14 infections missed by a paired blood culture – but proven to be a true infection by other cultures.
- T2Bacteria identified every infection detected by blood culture of the target species (100% sensitivity).
- T2Bacteria was highly accurate in identifying samples without an infection, with 99% average specificity.
The authors concluded that the advantages of T2Bacteria over blood culture could make it a valuable tool to enable faster time to targeted antibiotic therapy and reduced use of unnecessary antibiotics.
In a late-breaker poster from Northwestern University, clinicians found the T2Bacteria Panel was highly accurate compared to blood culture and detected 18 clinically important urinary and respiratory infections that were missed by blood culture. The authors concluded that T2Bacteria may improve patient care by providing clinicians rapid and actionable information for treating patients.
Finally, another late-breaker poster from the Centers for Disease Control and Prevention (CDC) on their validation of the Research Use Only diagnostic for the detection of the emerging superbug Candida auris, found that the T2 Magnetic Resonance (T2MR®) provided extremely accurate diagnostic results from patient skin samples. The poster concludes that T2MR could be used to provide a more rapid response to future outbreaks.
About the T2Bacteria Panel
The T2Bacteria Panel is the first and only FDA-cleared diagnostic panel that provides sensitive detection of specific sepsis-causing bacterial pathogens directly from a whole blood specimen in approximately 5 hours. This was more than 2.5 days faster than blood culture-dependent tests as demonstrated in an over 1,400 patient pivotal trial conducted at 11 hospitals in the United States. All other FDA-cleared diagnostic tests that detect bacteria in blood require a positive blood culture sample prior to bacterial species specific identification, which typically delays results by one to five days. Meanwhile, patient mortality rates increase almost 8% for each hour that targeted therapy is delayed. In addition to the more than tenfold improvement in time to result demonstrated in the pivotal clinical trial, the T2Bacteria Panel also achieved an overall average sensitivity of 90% and an overall average specificity of 98%, while demonstrating no interference from the presence of antibiotics in the bloodstream. The T2Bacteria Panel, like the previously FDA-cleared T2Candida Panel, runs on the Company’s proprietary, FDA-cleared T2Dx® Instrument. The FDA-cleared T2Bacteria Panel identifies five of the most common, and deadly sepsis-causing species of bacteria – where targeted therapy is often delayed: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
About Bloodstream Infections Treating bloodstream infections earlier may prevent progression to sepsis, one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs exceeding $27 billion. Sepsis claims more lives annually than breast cancer, prostate cancer, and AIDS combined and is the most prevalent and costly cause of hospital readmissions. The pathogens that cause sepsis infections are difficult to detect and can be deadly even at very small concentrations in the bloodstream. With sepsis, one hour of delayed treatment increases mortality risk by nearly 8%. The T2Bacteria Panel uses magnetic resonance technology to help detect the presence of five clinically relevant species of bacteria directly from a patient's blood sample in approximately five hours, versus one to five days or more with current diagnostic methods, potentially enabling more rapid treatment that may prevent the progression of a bloodstream infection to sepsis.
About T2 Biosystems:
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, 2017, filed with the U.S. Securities and Exchange Commission (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, 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.
Tom Langford, Feinstein Kean Healthcare
Matthew Clawson, W2O Group
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