Results achieved using only two mL of whole blood
LEXINGTON, Mass., June 2, 2016 – T2 Biosystems, Inc. (NASDAQ: TTOO), a company developing innovative diagnostic products to improve patient health, today announced that results from an investigational study evaluating its T2Candida® Panel utilizing two mL of whole blood in pediatric patients was published in the American Journal of Clinical Pathology (AJCP). The data demonstrate that in each of the 15 confirmed pediatric candidemia samples in the study, the T2Candida Panel was able to accurately identify the Candida species in three to five hours compared to up to six days for blood culture.
“The ability to receive a rapid sepsis diagnosis in children has been challenging given the large amount of blood required with currently available diagnostics,” said Camille Hamula, Ph.D., D(ABMM), director, microbiology, assistant professor, pathology, Icahn School of Medicine at Mount Sinai Hospital. “With T2Candida, we now have the opportunity to achieve fast, accurate results using lower than previous blood volumes, which may significantly change the way we diagnose and treat young patients at risk for sepsis”.
“These data show that our technology is able provide rapid and accurate results in young patients utilizing low blood volumes, which is critical in this patient population,” said John McDonough, chief executive officer of T2 Biosystems. “Our goal is to get patients of all ages on the appropriate therapy as quickly as possible, potentially saving lives.”
About the Study
The study included 15 confirmed candidemia patients between five and 12 years of age. Key findings included:
• The T2Candida Panel achieved accurate results with only two mL of blood using a manual pipetting procedure instead of the up to five mL volume required for blood culture, the current standard of care;
• The T2Candida Panel provided accurate species identification in all 15 patients in the study; and
• All results were achieved in three to five hours compared to up to six days for blood culture.
The T2Candida Panel was cleared for marketing by the U.S. Food and Drug Administration (FDA) in September 2014 for the detection of sepsis causing Candida in adult subjects.
About Candida
Candidemia is a systemic fungal infection that occurs when Candida organisms in the blood spread to organs and tissues throughout the body. Candidemia is the fourth leading hospital-acquired bloodstream infection and the most lethal form of common bloodstream infection that causes sepsis, according to the Center for Disease Control (CDC), with an approximate 40 percent mortality rate. 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. According to a study published in Antimicrobial Agents and Chemotherapy, the mortality rate can be reduced to 11 percent with the initiation of targeted therapy within 12 hours of presentation of symptoms. On average, candidemic patients require 40 days of hospitalization and have a hospital cost of $130,000.
About Sepsis
Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year, according to the U.S. Department of Health and Human Services. The T2Candida Panel uses T2 Magnetic Resonance (T2MR®) technology to detect the presence of the five clinically relevant species of Candida, the most lethal form of common blood stream infections that cause sepsis, directly from a patient’s blood sample in approximately three to five hours, enabling physicians to make timely treatment decisions to reduce adverse outcomes, patient mortality, and costs.
About The T2Candida Panel
The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three to five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient’s length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a Serious Threat.
About T2 Biosystems
T2 Biosystems is focused on developing innovative diagnostic products to improve patient health. With two FDA-cleared products targeting sepsis and a range of additional products in development, T2 Biosystems is an emerging leader in the field of in vitro diagnostics. The Company is utilizing its proprietary T2 Magnetic Resonance platform, or T2MR, to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. T2MR enables the fast and sensitive detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, eliminating the time-consuming sample prep required in current methods. For more information, please visit www.t2biosystems.com.
