Limit of Detection as Low as 1 CFU/mL- Data Presented at AMP 2015 Annual Meeting
LEXINGTON, Mass., Nov. 4, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, announced that data on its investigational T2Bacteria Panel will be presented today at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.
"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for blood culture," said Mike Pfaller, M.D., chief medical officer of T2 Biosystems. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives."
"The use of T2Candida and T2Bacteria, when combined with the practice of empirically administering broad spectrum antibiotics, may typically enable 95% of patients with sepsis to receive rapid and appropriate therapy," said John McDonough, chief executive officer of T2 Biosystems. "We are excited that the data in this study demonstrate the potential of T2Bacteria to enable the reduction in the current mortality rate of bacterial sepsis by 50%."
About the Study
The T2Bacteria Panel is being designed to run on the T2Dx instrument in conjunction with the T2Candida Panel. To achieve similar clinical performance to the T2Candida Panel, published data show that the T2Bacteria Panel will need to achieve a limit of detection (LoD) below 10 CFU/mL for each species. T2MR was able to demonstrate a high analytical sensitivity and high specificity for all bacterial targets. A LoD as low as 1 CFU/mL was observed for the targeted bacteria species spiked into healthy blood. The LoD for all bacterial species tested was determined by the cell concentration (CFU/mL) that resulted in a 95% or greater detection rate for 20 samples.
Data demonstrate the T2Bacteria Panel's ability to achieve limits of detection below 10 CFU/mL, and as low as 1 CFU/ml, similar to the performance demonstrated for the T2Candida Panel, in six clinically relevant bacteria species.
The six bacteria in the T2Bacteria Panel were selected because when combined with the use of T2Candida and the practice of empirically administering broad spectrum antibiotics, the rapid detection of these bacteria may enable 95% of patients with sepsis to receive rapid and appropriate therapy. These bacteria comprise 55% of all positive blood cultures and have growing resistance profiles.
About T2Bacteria Panel
The T2Bacteria Panel is being developed to provide a species-specific result in three-to-five hours, direct from whole blood, with no need for blood culture. Similar to the FDA-cleared T2Candida Panel, the T2Bacteria Panel will run on the fully automated T2Dx Instrument. To date, the T2Candida Panel has demonstrated 91.1% sensitivity, 99.4% specificity and limit of detection as low as 1 CFU/mL. Species-specific results are obtained in three-to-five hours versus 120+ hours for blood culture. To achieve similar performance, published data indicates that the T2Bacteria Panel would need to achieve a limit of detection below 10 CFU/mL for each species, which was demonstrated in this study.
Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year, according to the U.S. Department of Health and Human Services. The T2Candida Panel uses T2 magnetic resonance (T2MR) technology to detect the presence of five clinically relevant species of Candida, the most lethal form of common blood stream infections that cause sepsis, directly from a patient's blood sample in approximately three-to-five hours, enabling physicians to make timely treatment decisions to reduce adverse outcomes, patient mortality, and costs.
About The T2Candida Panel
The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three-to-five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient's length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a serious threat.
About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR®, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. The T2Candida Panel was cleared for marketing by the U.S. Food and Drug Administration (FDA) in September 2014 for the detection of sepsis causing Candida. T2Candida Panel performance was established in adult subjects. T2Candida Panel performance in neonates, infants, and pediatric patients has not been established. 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. 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, the performance of the Company's diagnostic products and the ability to bring such products to market. These and other important factors discussed under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2014, as supplemented or amended from time to time under "Item 1A.—Risk Factors" in our Quarterly Reports on Form 10-Q, 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.
CONTACT: Media Contact:
Susan Heins, Pure Communicationssusan@purecommunicationsinc.com
Matt Clawson, Pure Communicationsmatt@purecommunicationsinc.com
T2 Biosystems, Inc.