Immunexpress has received 510(k) clearance from the Food and Drug Administration for SeptiCyte LAB, the first RNA-based diagnostic tool that tests whole blood directly to aid in identifying infection early in suspected sepsis patients. The test quantifies four blood biomarkers of the patient’s immune response to infection in order to differentiate infection-positive inflammation (sepsis) from infection-negative inflammation (systemic inflammatory response syndrome, also known as SIRS).
Detecting the host response to infection has the potential to differentiate sepsis from SIRS earlier, faster, and more accurately than detecting the invading pathogen because the host response is independent of whether the pathogen is present in the sample. In a trial with 447 suspected sepsis patients, SeptiCyte LAB predicted 100% of patients with a positive blood culture in as few as 4.5 hours. In comparison, blood culture by itself—the traditional method for diagnosing sepsis—delivers a result in days and in only 10%–20% of suspected sepsis patients. Immunexpress hopes that the faster turnaround time provided by SeptiCyte LAB will help speed appropriate treatment to critically ill sepsis patients. SeptiCyte LAB also aids clinical decisions involving patients without infection and in whom de-escalation of care and reducing antimicrobial treatment are appropriate.