T2 Biosystems Announces Publication of Data Demonstrating T2Candida® Identifies Candida Significantly Faster than Current Methods

T2 Biosystems Announces Publication of Data Demonstrating T2Candida® Identifies Candida Significantly Faster than Current Methods

October 17, 2013

--Direct Detection and Species Identification from Whole Blood Provides Results in Approximately Three Hours vs. an Average of Greater Than 3 Days for the Current Gold Standard, Blood Culture--

-Limit of Detection as Low as 1 CFU/mL-

LEXINGTON, Mass. -- T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that collaborators from the University of Houston College of Pharmacy have published data demonstrating that T2Candida® identifies species-specific Candida in approximately three hours compared with an average of 2.6 days for blood culture to become positive, which is the current gold standard. After a blood culture becomes positive, it still requires further analysis to identify the specific species detected, which may add another day before providing an informed diagnosis. T2Candida is T2 Bio’s rapid and highly sensitive test for the identification of five species of Candida directly from whole blood with limits of detection as low as 1 CFU/mL. The data were published online today in Diagnostic Microbiology and Infectious Disease.

“Candidemia has a high mortality rate of over 40% due to the delay in diagnosis and initiation of appropriate therapy. Based on these results, T2Candida has the potential to deliver clinically meaningful species-specific diagnoses of Candida infection that would allow for early initiation of the appropriate antifungal therapy where time is of the essence,” said Kevin Garey, PharmD, MS, Associate Professor of Pharmacy Practice, Chair, Department of Clinical Sciences & Administration, and Division Head, Experimental Therapeutics and Clinical Pharmacology at the University of Houston College of Pharmacy and Principal Investigator of the study.

“These data from the University of Houston provide additional validation of our T2MR® technology and demonstrate its potential to improve the care of patients not only for sepsis, but for any condition benefitting from molecular, immunodiagnostic and hemostasis testing,” commented John McDonough, President and CEO, T2 Biosystems. “In addition to potentially saving lives of patients, early detection of Candida infections with T2Candida could have significant economic benefits, including a reduction in both hospital length of stay and unnecessary antimicrobial therapy.”

About the Study

The study, entitled “Comparison of the T2Dx Instrument with T2Candida Assay and Automated Blood Culture in the Detection of Candida species Using Simulated Blood Cultures”, was authored by Nicholas D. Beyda, M. Jahangir Alam and Kevin W. Garey of the University of Houston College of Pharmacy. In this study, the performance of the automated blood culture analyzer, BACTEC 9050, was compared to that of the T2Candida® assay run on the T2Dx® instrument for detection of five species of Candida (C. albicans, C. tropicalis, C. parapsilosis, C. glabrata and C. krusei). The BACTEC 9050 detected Candida growth in 100% of bottles (n=20 replicates) within 5 days for all species (63.23 ± 30.27 hours), with the exception of C. glabrata (0%). The T2Candida assay had a 100% detection rate for each species (n=13-20 replicates) in approximately three hours, including C. glabrata. The sensitivity and specificity of the T2Candida assay was 1 and 0.978 respectively. The study demonstrated that T2Candida could provide a rapid and sensitive means to detect species-specific Candida directly from whole blood, resulting in potential clinical and economic benefits.

About Sepsis & Candidemia

Sepsis is a potentially life-threatening illness caused by the body’s severe reaction to infection by bacteria, fungi, viruses or parasites. It is one of the top 10 leading causes of death in the United States, and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis, and it is associated with approximately 100,000 cases of candidemia in the U.S. annually, making it the fourth-leading cause of hospital-acquired infections. Currently, candidemia has a 40% mortality rate, which can be reduced to 11% with early identification of the specific species. Current detection methods rely on blood culture, a process that can take two to five days before identifying a Candida infection. The T2MR® platform is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology, even at low copy numbers, and provide results in approximately three hours.

About T2 Biosystems

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR®, the Company’s proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate and rapid assay results. The Company’s products detect molecular, hemostasis or immunodiagnostic targets directly from unpurified clinical samples in hospitals, labs and physicians’ offices. For more information, please visit www.t2biosystems.com.