Lexington, MA, April 24, 2013 (Embargoed until 2:00 PM US Eastern Time) – T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the publication of research supporting the Company's flagship diagnostic test, T2Candida®, in Science Translational Medicine. The research highlights T2Candida as a breakthrough approach to rapid and sensitive identification of species-specific Candida, a sepsis-causing fungus, directly from whole blood in approximately three hours, or up to 25 times faster than the current gold standard of blood culture. This publication marks the first clinical study of patient samples with T2 Magnetic Resonance (T2MR®) technology. Bloodstream infections of Candida, known as candidemia, are associated with a 40% mortality rate, largely due to the elapsed time from infection onset to pathogen diagnosis and treatment, which can take from two to five days with blood culture. With early identification of the specific species, this high mortality rate can be reduced to 11%.
"The rapid detection of Candida is of critical need within the healthcare community, where time is of the essence to enable life-saving treatment decisions," said Eleftherios Mylonakis, MD, Dean's Professor of Medicine, Chief, Infectious Disease Division, Warren Alpert Medical School of Brown University, and investigator in this study. "Studies have shown that each hour of delayed treatment increases the mortality of sepsis patients significantly, by up to 8% or more. This research outlines how T2 magnetic resonance can revolutionize the field, with great implications on mortality rates and healthcare costs."
"This research represents the first time that Candida has been identified directly from whole blood in patient samples with highly sensitive T2MR technology that affords limits of detection as low as 1 CFU/mL," added Tom Lowery, PhD, Vice President, Diagnostics Research & Development, T2 Biosystems, and principle investigator of the study. "Importantly, this T2MR approach to Candida identification is also amenable to virtually any molecular, immunoassay or hemostasis target, and we are currently developing a portfolio of products where high sensitivity and rapid detection will have the greatest impact on healthcare."
"T2MR represents a revolutionary, highly-sensitive nanotechnology solution, which can rapidly detect pathogens leading to early intervention that can save lives," said Robert S. Langer, D. Sc., David H. Koch Institute Professor, MIT, and co-founder and board member of T2 Biosystems. "T2Candida exemplifies the potential of nanotechnology to create great advances in healthcare in the near term."
In the paper entitled "T2 magnetic resonance enables nanoparticle-mediated rapid detection of candidemia in whole blood", the authors introduce a novel diagnostic method based on T2 magnetic resonance (T2MR). The T2Candida assay uses blood-compatible polymerase chain reaction (PCR) to amplify Candida DNA, which then binds to superparamagnetic nanoparticles coated with a complementary DNA strand. The binding event causes the nanoparticles to cluster, which changes the sample's T2MR signal. Using this approach, the researchers tested both Candida-spiked and patient samples and were able to rapidly, accurately and reproducibly detect five Candida species within human whole blood with a limit of detection as low as 1 CFU/mL and a time-to-result of approximately three hours. Spiked samples showed 98% positive agreement and 100% negative agreement between T2MR and blood culture. Clinical samples demonstrated similar concordance with blood culture with the important distinction that T2MR was able to identify Candida species in the presence of antifungals, whereas blood culture could not. This study suggests that rapid diagnosis of specific Candida species is achievable with T2MR technology, which is fully automated and applicable to a broad variety of targets.
Study authors included Lori A. Neely, Mark Audeh, Nu Ai Phung, Michael Min, Adam Suchocki, Daniella Plourde, Matthew Blanco, Vasiliki Demas, Lynell R. Skewis, Parris Wellman and Thomas J. Lowery of T2 Biosystems, Theodora Anagnostou of Brown University and Jeffrey J. Coleman and Eleftherios Mylonakis of Brown University and Massachusetts General Hospital.
T2Candida is for research use only. The test has not been cleared by FDA, and is not available for diagnostic use at this time.
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 immunoassay targets directly from unpurified clinical samples in hospitals, labs and physicians' offices. For more information, please visit http://www.t2biosystems.com.
Special Notes to Reporters
More information, including a copy of the paper, can be found online at the Science Translational Medicine press package at http://www.eurekalert.org/jrnls/scitransmed. You will need your user ID and password to access this information. For multimedia only associated with this release, please visit: http://www.t2biosystems.com/media.
Journal
Science Translational Medicine