Enhancing the efficiency and accuracy of blood testing, T2 Biosystems announced the results from an investigational study evaluating the T2Candida Panel utilizing only 2 mL of blood from pediatric patients at the 115th General Meeting of the American Society for Microbiology in New Orleans.
T2 Biosystems is a company developing innovative diagnostic products to improve patient health. Moreover, 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 data demonstrated that in each of the 15 confirmed candidemia pediatric patient samples in the study, T2Candida was able to accurately identify the Candida species in three to five hours compared to two to six days for blood culture. In addition, the protocol was adapted in this study to be able to detect results from just 2 mL of blood compared to the 3 mL that is currently required for testing.
“Fast and accurate results have been a challenge to obtain in pediatric patients suspected of sepsis due to the volume of blood required by current diagnostic procedures,” said Camille Hamula, Ph.D., assistant director, microbiology and assistant professor, pathology, Mount Sinai Hospital/Icahn School of Medicine at Mount Sinai. “This new loading procedure maintains the high accuracy and fast results of the T2Candida Panel, but with lower sample volume, which could have an important impact on the lives of young patients at risk of sepsis.”
The T2Candida Panel was cleared for marketing by the U.S. Food and Drug Administration in September 2014 for the detection of sepsis causing Candida. T2Candida Panel performance was established in adult subjects. T2Candida Panel performance in neonates, infants and pediatric patients has not been established.