FDA Clears Molecular Assay for Suspected Sepsis Patients

RNA-based test identifies biomarkers in whole blood

Immunexpress, Inc., a molecular diagnostic company based in Seattle, has received 510(k) clearance from the FDA for the use of its SeptiCyte LAB assay as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of admission to the intensive care unit. 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, according to the company.

Sepsis is the most expensive in-patient cost in U.S. hospitals, totalling more than $20 billion each year. Currently, confirmation of a clinical diagnosis of sepsis relies on the detection of pathogens, which can take up to several days.

In a study involving 447 suspected sepsis patients, the SeptiCyte LAB assay predicted all patients with a positive blood culture within hours, the company claims. By identifying four blood biomarkers, clinicians can access objective information to aid providers in diagnostic and targeted treatment decisions.

The SeptiCyte technology quantifies, in whole blood, specific molecular markers from the patient’s immune system––the “host response.” Detecting the host’s response to infection has the potential to differentiate infection earlier and more accurately than finding the invading pathogen because the assay results are independent of whether or not the pathogen is present in the sample.

Source: Immunexpress; February 22, 2017.