BioDtech, Inc. (BDTI) found there has been an unmet need in the field of pyrogen testing for an assay that is specific, accurate and reliable for endotoxin. The assays that are currently accepted by the FDA and pharmacopeias worldwide are based on Limulus (horseshoe crab) amebocyte lysate (LAL) clotting in response to endotoxin. This assay lacks specificity because it reacts with glucans associated with yeast; the accuracy is ± 50% and requires specific conditions for a delicate enzymatic reaction to occur. In addition, LAL requires the harvesting of wildlife species.
To circumvent these problems, scientists from the National University of Singapore have dissected the enzymatic reaction and identified the molecular site where endotoxin binds to Factor C enzyme which initiates the LAL clotting reaction. The peptide of the sushi domain of the Factor C endotoxin binding site can be made chemically. This is the basis for BDTI's technology for the detection, neutralization and removal of endotoxin.
The sushi peptide can be labeled for detection, coupled to a support for removal or added directly to a sample for neutralization. The sushi peptide has a high affinity and specificity for endotoxin which approaches that of the natural molecule without reactivity with glucans. It also allows a broad range of assay conditions unlike the native enzyme which increases accuracy and reliability