T2Endotoxin assay extends reach of T2MR detection

T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the presentation of data on endotoxin detection at the American Society for Microbiology General Meeting, June 16-19, 2012, in San Francisco, CA. The T2Endotoxin assay is a novel method to screen injectable drugs and medical devices for the presence of endotoxins that are produced by gram negative bacteria or fungi, combining the standard Limulus Amoebocyte Lysate (LAL) reagent with Company's T2MR technology. LAL forms a gel in response to the presence of endotoxin and changes in LAL are directly measured by T2MR, similar to the T2Hemostasis application for coagulation and platelet disorders. The data presented at ASM demonstrate that the T2Endotoxin assay provided higher sensitivity, faster detection and lower reagent consumption when compared with commercially available assays.

“The T2Endotoxin assay extends the reach of T2MR detection to the screening of injectable drugs and medical devices for the presence of endotoxin, which is produced by gram negative bacteria and fungi, a field where the current methods rely on decades-old technology”

"The T2Endotoxin assay extends the reach of T2MR detection to the screening of injectable drugs and medical devices for the presence of endotoxin, which is produced by gram negative bacteria and fungi, a field where the current methods rely on decades-old technology," said John McDonough, CEO, T2 Biosystems. "T2Endotoxin enables rapid and ultrasensitive detection of endotoxin, with reduced reagent consumption, delivering many of the same advantages that T2 Biosystems brings to molecular and hemostasis assays. The addition of T2Endotoxin to the range of applications enabled by T2MR demonstrates the versatility of our platform and its ability to solve diverse analytic problems."

The FDA requires that injectable drugs and medical devices are screened for endotoxin, which is produced by gram negative bacteria or fungi. The Limulus Amoebocyte Lysate (LAL) reagent is widely used for its ability to form a gel in the presence of endotoxin, resulting in a highly sensitive detection method. The T2Endotoxin assay utilizes T2MR technology to sense the formation of the LAL gel, similar to blood clotting, which enables higher sensitivity, faster detection and lower reagent consumption.

In the presentation entitled "Rapid ultrasensitive method for endotoxin detection utilizing T2MR and LAL test reagents", the T2Endotoxin assay was compared with two commercially available turbidimetric LAL assays. Dose response curves were generated for 0 - 100 EU/mL endotoxin levels and the T2Endotoxin assay demonstrated a sensitivity of 0.0001 EU/mL with a turn-around time of 37 min. When compared to the turbidimetric LAL endotoxin test, detection times were reduced ≥50%, sensitivity improved by 100x and per test reagent consumption was lowered by 80%. Correlation plots for endotoxin level vs. clotting time show excellent correlation with R2 ≥0.98. Similar results were observed for LAL detection of 1,3-β-D-Glucan.

Source T2 Biosystems