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 Study Group in Philadelphia, PA.
“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.”
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, healthcare costs and patient mortality.
"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 blood samples.
"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 on its technology.