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T2 Biosystems Demonstrates First-Ever Ability to Accurately and Rapidly Detect
Systemic Candida Infection Directly in Whole Blood in Single-Process Test
Data  Presented  at  Annual  Meeting  of  Mycoses  Study  Group  Demonstrates  Rapid  
Identification  of  the  Most  Deadly  Form  of  Common  Hospital-­‐Acquired  Infections  
Magnetic  Biosensor  Nanotechnology  Enables  Universal  Detection  of  Targets  on  Single  

Lexington, MA (April 7, 2011) – T2 Biosystems, Inc., a company developing next-
generation diagnostic products, presented data today on the rapid and sensitive detection of five species of the fungal infection Candida at the Annual Meeting of the Mycoses The data demonstrate the ability of T2 Biosystems’ proprietary technology platform to detect Candida organisms in whole blood samples in less than two hours from sample to result, with very high sensitivity, specificity and accuracy. This initial data supports the capability for T2 Biosystems’ technology to provide significant clinical advantages in time, healthcare cost and associated patient mortality when compared to the currently available multiple-day diagnosis of Candida from blood culture. The system utilizes magnetic biosensor nanotechnology that is designed to enable detection of DNA, RNA, protein, small molecules and a number of other targets from a single sample and single platform. The company plans to submit the diagnostic device, including the Candida application, for clearance by the U.S. Food and Drug Administration in 2012. Candidemia, a systemic fungal infection that occurs when Candida organisms are present in the blood, is a potentially life-threatening bloodstream infection. Each year, an estimated 60,000 patients contract candidemia in the United States alone, and this incidence continues to rise. It is the most deadly of the common hospital-acquired bloodstream infections, and currently results in significant increased hospital stays, “The current standard of care in Candida detection involves analyzing biological samples using culture-based methods that typically take several days to produce a result. During this time, patients are often treated with broad spectrum antibiotics, which introduce additional complications to exacerbate the infection and can lead to significant morbidity and mortality,” said Peter Pappas, MD, Principal Investigator of the Mycoses Study Group. “If we rely on current post-culture diagnostic techniques, roughly 40% of patients suffering from candidemia will not survive. This underscores the need for rapid and accurate diagnostics to ensure early and appropriate therapy that can save patient lives.” The T2 Biosystems data presented at the Mycoses Study Group meeting includes an evaluation of more than 400 human whole blood samples spiked with clinical isolates and lab strains for Candida albicans, Candida krusei, Candida glabrata, Candida tropicalis, and Candida parapsilosis. The tests demonstrate that the T2 Biosystems method was able to detect all five species of Candida in whole blood, pre-culture samples with 95% sensitivity and 98% specificity. Additionally, greater than 98% positive agreement with blood culture was demonstrated for over 160 spiked patient samples with clinical isolates and lab strains. These results were reproducible across different days and different patient “The results from our tests to detect Candida in whole blood samples in less than two hours are unprecedented and represent a major breakthrough for this deadly fungal infection,” said John McDonough, Chief Executive Officer of T2 Biosystems. “This is a terrific example of how T2 Biosystems’ technology removes the sample preparation barriers of existing diagnostics to improve patient outcomes by enabling rapid detection directly in whole blood samples for the most challenging diagnostic tests.” T2 Biosystems’ magnetic biosensor nanotechnology has been applied to the sensitive detection of a broad range of analytes, including viruses, bacteria, proteins, hormones, DNA, RNA, small molecules and other diagnostic targets, and has been published in over 100 journal articles. The company is developing a pipeline of diagnostic products based About T2’s Magnetic Biosensor Technology
Unlike culture based diagnostic methods that utilize optical signals and require preparation of a clean biologic sample, T2’s magnetic biosensor technology combines nanotechnology with the power of magnetic resonance detection. A “dirty sample” of a patient’s blood, saliva, urine or other biofluid is loaded directly into a desktop instrument via a disposable cartridge. The sample is then mixed with magnetic nanoparticles and analyzed for the presence of specific fungal, bacterial or viral pathogens or biomarkers using a technique similar to magnetic resonance imaging (MRI). The system is able to detect low concentrations of target agents or specific pathogens and present a result to the About Candida Infections
Candidemia is a systemic fungal infection that occurs when Candida organisms in the blood spread to organs and tissues throughout the body. An estimated 60,000 patients contract candidemia in the United States each year.1 While not all cases are hospital acquired, it is the most deadly of the common hospital acquired infections, with a mortality rate of 40% compared to 27% mortality for hospital acquired infections in general.2,3 In the absence of a rapid, accurate diagnostic, appropriate therapeutic intervention for candidemia is often delayed, resulting in a mortality rate that is three to four times higher than when early, targeted therapy is initiated.4,5 Patients at high risk for candidemia and systemic Candida infection include those with compromised immune systems, transplant recipients, patients on chemotherapy, patients with catheters, patients in critical care units, surgical patients and patients on prolonged antibiotic therapy. Candidemia contributes to an average of 23 additional days in the hospital per patient6 and experts estimate that patients who suffer from candidemia cost the U.S. healthcare About T2 Biosystems, Inc.
T2 Biosystems is a private biomedical company developing next-generation medical diagnostic products using its proprietary NanoDx™ magnetic biosensor technology platforms to provide rapid, accurate and scalable diagnostics for both centralized and decentralized clinical settings. T2 Biosystems was founded in 2006 by renowned researchers from the Massachusetts Institute of Technology, Harvard University, Harvard Medical School and Massachusetts General Hospital, and has assembled a world class team, board of directors and scientific advisory board that collectively have a proven track record of translating technologic innovations into breakthrough products, building significant corporate value. T2 Biosystems is located in Lexington, Massachusetts. For more information, please visit the company's website at 1. Data on file - Mycology from the perspective of the Clinician, Wingard JR. 2. Pfaller MA, Diekema DJ. Epidemiology of Invasive Candidiasis: a Persistent Public Health Problem. Clinical Microbiology Reviews, 2007; 20 (1): 133–163. 3. Edmond MB, Wallace, SE, McClish DK, et al. Nosocomial Bloodstream Infections in United States Hospitals: A Three-Year Analysis. Clinical Infectious Diseases, 1999; 29: 239–44. 4. Morrell M, Fraser VJ, Kollef MH. Delaying the Empiric Treatment of Candida Bloodstream Infection until Positive Blood Culture Results Are Obtained: a Potential Risk Factor for Hospital Mortality. Antimicrobial Agents And Chemotherapy, 2005; 49(9): 3640–3645. 5. Garey KW, Rege M, Pai MP, et al. Time to Initiation of Fluconazole Therapy Impacts Mortality in Patients with Candidemia: A Multi-Institutional Study. Clinical Infectious Diseases 2006; 43:25–31. 6. Gagne JJ, Breitbart RE, Maio V, et al., Costs Associated with Candidemia in a Hospital Setting. P&T 2006; 31(10) 586-619. 7. Wilson LS, Reyes CM, Stolpman M, et al. The Direct Cost and Incidence of Systemic Fungal Infections. Value in Health 2002 ; 5(1). Kathryn Morris The Yates Network Tel: 845-635-9828 [email protected]


No. 06-1249 In the Supreme Court of the United States On Petition for a Writ of Certiorari to the Vermont Supreme Court BRIEF OF AMICI CURIAE PRODUCT LIABILITY ADVISORY COUNCIL, INC. AND U.S. CHAMBER OF COMMERCE IN SUPPORT OF PETITIONER Washington, DC 20006(202) 263-3000 1615 H Street, N.W. Washington, D.C. 20062 TABLE OF CONTENTS The Decision Below Thwarts Important

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