T2 Biosystems, Inc., a company developing innovative diagnostic products to improve patient health, today announced the presentation of results from an investigational study evaluating the T2Candida® Panel utilizing only 2mL of blood from pediatric patients at the 115th General Meeting of the American Society for Microbiology (asm2015) in New Orleans. The data presented today demonstrate 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 2mL of blood compared to the 3mL that is currently required for testing. 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. T2Candida Panel performance was established in adult subjects. T2Candida Panel performance in neonates, infants, and pediatric patients has not been established.
“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., D(ABMM), assistant director, microbiology and assistant professor, pathology, Mount Sinai Hospital/Icahn School of Medicine at Mount Sinai and lead investigator on the study who presented the findings.
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
“We are encouraged by these findings demonstrating that our T2Candida Panel was able to provide accurate results from lower blood volumes, which is critical in the pediatric patient population,” said John McDonough, president and CEO of T2 Biosystems. “Similar to adults, the ability to quickly and accurately detect sepsis in children can help save costs, but more importantly, save lives.”
About the Study
The study included 15 confirmed candidemia patients between the ages of five and 12 years of age. Key findings from the study included:
- The T2Candida panel achieved accurate results with only 2mL of blood using a manual pipetting procedure instead of the 3mL volume required with the standard loading procedure;
- The T2Candida Panel provided accurate identification of the species for all 15 patients in the study; and
- All results were reported within three-to-five hours, compared to approximately two to six days for blood culture.
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.