LEXINGTON, Mass., Oct. 12, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced new data presented during the IDWeek 2017 Conference on the T2Sepsis SolutionTM, which includes the T2Bacteria® Panel, commercially available in Europe today and recently submitted to the FDA in the United States for market clearance, and the T2Candida® Panel, commercially available in both the United States and Europe, coupled with the current standard of care of providing broad spectrum antibiotics to symptomatic patients.
“A growing dataset continues to highlight the strong performance of the T2MR platform. The diagnostic superiority of the T2Candida Panel over blood culture has been proven in multiple studies and new data demonstrate the prognostic potential of this technology,” said Cornelius J. Clancy, M.D., Associate Professor of Medicine, Director, Mycology Program, University of Pittsburgh; Chief, Infectious Diseases Section - VA Pittsburgh Healthcare System. “With the addition of the T2Bacteria Panel, once FDA-cleared, I expect most hospitals will want to offer this technology to their clinicians for routine clinical use.”
The T2MR platform is detecting infections missed by blood culture and demonstrates consistently strong performance, as reported by Dr. Clancy in the panel presentation “T2Sepsis Solution: The Impact of Direct from Whole Blood Diagnostics on the Management of Bloodstream Infections.”
- T2Candida Panel identified 37 cases of Candida infections missed by companion blood cultures for patients receiving antifungal therapy in a multi-center DIRECT2 study.
- Findings suggest that T2Candida is more sensitive than blood culture, especially in the presence of antifungal treatment, and a more effective diagnostic tool for patients treated with pre-emptive or empiric antifungal therapy.
- Accumulating data for T2Candida’s performance in clinical practice demonstrate a sensitivity at about 90% and specificity ranging from 98% to 99%.
The T2Bacteria Panel investigational data provide insight into the compelling clinical value for hospitals in the emergency department and inpatient care, as reported by Glen T. Hansen, Ph.D., Director of Clinical Microbiology and Molecular Diagnostics, Hennepin County Medical Center (HCMC) in a panel presentation.
- HCMC patient analysis suggests the T2Bacteria Panel will cover between 85% and 90% of patient cases that come into the hospital through the emergency department.
“I believe the T2Sepsis Solution is the ‘holy grail’ of bloodstream infection diagnostics. No other product can give me virtually hands-free, automated pathogen detection and identification directly from a whole blood sample,” said Dr. Hansen. “With the T2MR platform, I expect my laboratory will get accurate, actionable results to clinicians faster, so patients get on the right treatment earlier when it matters most.”
In addition, the following are highlights from poster presentations at IDWeek 2017:
- New data on the ability of the T2MR platform to detect the superbug Candida auris was presented by T2 Biosystems.
• The T2MR platform successfully identified Candida auris in patient samples at La Fe University and Polytechnic Hospital in Spain.
• Average time to identification with the T2MR platform was less than 5 hours while time to positive blood culture ranged from 19 to 83 hours prior to subsequent identification.
- The T2MR platform detected infections missed by blood culture and led to the avoidance or de-escalation of unnecessary antifungal therapy at Huntsville Hospital.
• The T2Candida Panel demonstrated overall sensitivity of 94.4% and identified 26 proven infections that were not detected by blood culture.
• Negative T2Candida Panel results contributed to the avoidance or de-escalation of antifungal therapy in 64% of these negative patients.
• Negative T2Candida results decreased the average duration of micafungin therapy by 2.1 days.
• The authors concluded that the T2Candida Panel demonstrated greater sensitivity for Candida infections and generated results much faster than blood culture.
- The T2MR platform led to reduced use of antifungals and cost savings at Robert Wood Johnson Hospital.
• Antifungal therapy was avoided or ceased in 67% of patients with a negative T2Candida result and resulted in cost savings due to reduced use of antifungal drugs.
- The T2MR platform identified infections missed by blood culture and reduced the time to initiation of therapy by 1.5 days at the University of Alabama at Birmingham Hospital.
• The authors concluded that the T2Candida Panel demonstrated excellent sensitivity (86%) in a real world setting.
• T2Candida identified 23 patients that blood culture missed.
• Rapid T2Candida test results led to accelerating the time to treat patients with the right targeted therapy by 1.5 days.
“Clinical and practical use of the T2MR platform continues to grow, and the impact is being shared by customers who are experiencing the value of the platform’s superior accuracy and time to result when compared to blood culture,” said John McDonough, president and chief executive officer of T2 Biosystems. “IDWeek presented an excellent opportunity to share the powerful data and case studies around the T2Candida and T2Bacteria Panels, which sets the stage nicely for our commercial expansion of the T2Sepsis Solution over the next year.”
About T2 Biosystems
T2 Biosystems, an emerging leader in the field of in vitro diagnostics, 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 SolutionTM 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 www.t2biosystems.com.
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.
Darlene Deptula-Hicks, T2 Biosystems
SVP & Chief Financial Officer
Amy Phillips, Feinstein Kean Healthcare
Chris Brinzey, Westwicke Partners