The FDA granted 510(k) clearance to Immunexpress for the use of its 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 ICU admission.
SeptiCyte LAB 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, according to the company.
“Sepsis is a medical emergency. When recognized and treated early, lives are saved and costs are reduced,” said Roy Davis M.D., Ph.D., Immunexpress’ CMO. “Standardized, rapid, and objective diagnostics are needed for better clinical agreement in these patients. The SeptiCyte LAB blood test aids in differentiating infection in 100% of suspected sepsis patients in as few as 4.5 hours from sample draw.”
Sepsis is a complication caused by a patient’s overwhelming and life-threatening immune response to infection and can lead to tissue damage, organ failure, and death. It is the most expensive in-patient cost in U.S. hospitals, totaling over $20 billion each year. Currently, confirmation of a clinical diagnosis of sepsis relies on pathogen detection, which can take up to several days.
“In 447 suspected sepsis patients, SeptiCyte LAB predicted all patients with a positive blood culture in a matter of a few hours,” added Roslyn Brandon, Ph.D., president and CEO at Immunexpress. “This is a major advance over the currently available technology that delivers a result in days, not hours, and in only 10% to 20% of suspected sepsis patients.”
Immunexpress is aiming to revolutionize clinical diagnostics for suspected sepsis patients by facilitating earlier, faster, and more specific infection recognition using the patient’s own inflammatory response, explained Dr. Brandon.
“By identifying four blood biomarkers, clinicians can access objective information to aid providers in diagnostic and targeted treatment decisions,” she continued. ”This revolutionary technology will also aid clinical decisions in patients without infection where de-escalation of care and reducing antimicrobial treatment are appropriate."
Dr. Brandon noted that “the company is in advanced discussions with potential IVD and point-of-care instrument partners for the development of automated versions of the test, which will be submitted to the FDA. The company also continues discussions with a key IVD partner in respect of a staged, commercial launch of SeptiCyte LAB in the second half of 2017.”