LEXINGTON, Mass.--(EON: Enhanced Online News)--T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that it will provide demonstrations of its flagship test, T2Candida®, for the rapid and sensitive identification of species-specific Candida directly from whole blood, on its T2Dx® instrument at Booth #922 at IDWeek 2013, October 2-6, 2013, in San Francisco, CA. Without the need for blood culture, T2Candida directly detects five species of Candida in a whole blood specimen in approximately 3 hours with a limit of detection as low as 1 CFU/mL. The T2Candida test is currently being evaluated in a pivotal clinical trial, and results will be available in the first half of 2014.
T2Candida has the potential to address a significant health threat as described in the recently published report on Antimicrobial Resistant Threats in the United States, 2013 by the U.S. Department of Health and Human Services through the Centers for Disease Control and Prevention, which places Candida in the Serious Hazard Level category. As a Serious Threat, the CDC warns that ongoing monitoring and prevention is necessary to prevent Candida from becoming an Urgent Hazard.
The T2Candida assay is run on the T2Dx instrument, which utilizes the Company’s T2MR® technology. T2MR uses miniaturized magnetic resonance to directly detect any immunodiagnostic, molecular or hemostasis target from complex clinical samples, such as whole blood, plasma, serum, sputum and urine.
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 greater than 40% mortality rate, which can be reduced to 11% with appropriate treatment within 12 hours of presentation. Current detection methods rely on blood culture, a process that can take two to five days before identifying a Candida infection. The T2Candida® test 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 which provides sensitive, accurate and rapid assay results. The Company’s products are capable of detecting molecular or immunoassay targets as well as hemostasis biomarkers directly from unpurified clinical samples in hospitals, labs and physicians’ offices. For more information, please visit www.t2biosystems.com.