Immunexpress Sepsis Test Cleared by FDA

Molecular diagnostic company Immunexpress has received 510(k) clearance for the use of SeptiCyte LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission. “It is the first RNA-based clinical diagnostic tool, direct from whole blood, to aid medical providers in the early identification of infection in suspected sepsis patients,” the company says. The blood test aids in differentiating infection in 100% of suspected sepsis patients in as few as 4.5 hours from sample draw, it says. Currently, confirmation of a clinical diagnosis of sepsis relies on pathogen detection, which can take up to several days. Clearance was based on data from a study in 447 suspected sepsis patients, which showed that SeptiCyte LAB predicted all patients with a positive blood culture in a matter of a few hours.