T2 Biosystems Submits 510(K) Application To The FDA For Review Of T2Bacteria Panel
Published: Sep 11, 2017
LEXINGTON, Mass., Sept. 11, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, today announced that it has filed a 510(k) premarket submission for the T2Bacteria Panel with the U.S. Food and Drug Administration (FDA). The T2Bacteria Panel is designed to run on the FDA-cleared T2Dx Instrument. The T2Bacteria Panel, once FDA cleared, combined with the commercially available T2Candida Panel is designed to be the first comprehensive rapid diagnostic solution on the market that identifies pathogens associated with sepsis within hours instead of days, potentially enabling 95% of patients with bloodstream infections to receive targeted therapy within 8 hours of blood draw.
The premarket submission includes data from the pivotal clinical trial that evaluated the performance of the T2Bacteria Panel compared to blood culture, as well as the performance of the Panel in known bacteria positive samples. The pivotal clinical trial was conducted at 11 hospital sites and consisted of analyzing 1,777 clinical samples. The combined results from the prospective and seeded arms of the study show an average sensitivity of 95.8% and an average specificity of 98.1%. A more complete summary of the product performance is contained in the company’s Form 8-K filed today with the SEC.
“Bacterial infections are a major cause of poor health outcomes and a driver of costs in hospitals today,” said Mitchell J. Cohen, M.D., Professor of Surgery at the University of Colorado. “There is a great need for improved diagnostics to aid clinicians in providing faster treatment and the T2Bacteria Panel is the first product submitted for FDA clearance that detects bacteria species directly from whole blood, providing faster, actionable information.”
The T2Bacteria Panel is designed to identify six species of bacteria directly from human whole blood specimens: Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.
“The filing of T2Bacteria brings us one step closer to achieving our goal of providing the healthcare system with a comprehensive sepsis solution,” said John McDonough, president and chief executive officer. “We are very pleased with the performance of the T2Bacteria Panel in the pivotal clinical trial as the product has demonstrated performance comparable to our FDA-cleared T2Candida Panel. We have already seen significant interest from hospitals in using the product under a Research Use Only program that we offered on a limited basis this past spring.”
Sepsis is one of the leading causes of death in the United States, affecting more than 1.6 million patients each year, and it is the most expensive hospital-treated condition with costs to healthcare systems over $27 billion each year. Sepsis is a condition caused by the body’s immune system’s inability to fight off bacterial or fungal infections that stem from any number of serious illnesses including pneumonia, abdominal, kidney, or other bloodstream infections. The condition is typically diagnosed by culturing blood samples from patients suspected of sepsis. Blood culture-based diagnostics can take one to six or more days, prompting clinicians to rely on empiric therapy that may lead to the overuse of antibiotics or antifungals, misdiagnosis and poor patient outcomes. A rapid diagnostic solution that is able to detect sepsis-causing infections and enable targeted therapy in hours presents the opportunity for better patient outcomes and the potential to save billions of dollars in healthcare costs.
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 best 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. 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, it disclaims any obligation to do so, even if subsequent events cause its views to change. 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