FDA approves new sepsis diagnostic tool

The Food and Drug Administration approved the first RNA-based clinical diagnostic tool for the identification of sepsis.

SeptiCyte Lab — manufactured by Seattle-based molecular diagnostic company Immunexpress — can identify four blood biomarkers indicative of sepsis. The diagnostic tool can rapidly differentiate between sepsis and systemic inflammation in critically ill patients on their first day in the intensive care unit.

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"In 447 suspected sepsis patients, SeptiCyte LAB predicted all patients with a positive blood culture in a matter of a few hours," said Roslyn Brandon, PhD, president and CEO of 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 percent of suspected sepsis patients."

Sepsis is a potentially deadly complication caused by the body's immune response to life-threatening infections, which can result in tissue damage and organ failure. Sepsis accounts for more 30-day readmissions than heart attack, heart failure, chronic obstructive pulmonary disease and pneumonia.

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