FDA clears Immunexpress’ RNA-based, whole-blood sepsis Dx

Immunexpress earned 510(k) clearance for its RNA-based clinical diagnostic that detects sepsis in critically ill patients. The test, which uses whole blood, returns results in a few hours.

Sepsis is one of the leading causes of death in the intensive care unit, according to the National Institute of General Medical Sciences. It is a result of an “overwhelming” immune response to infection and can lead to extensive inflammation, organ failure and death.

Immunexpress’ SeptiCyte LAB differentiates between infection-positive systemic inflammation (sepsis) from infection-negative systemic inflammation, according to a statement. It is the first RNA-based clinical diagnostic tool that helps caregivers identify sepsis early, the company said.

"In 447 suspected sepsis patients, SeptiCyte LAB predicted all patients with a positive blood culture in a matter of a few hours,” said Immunexpress CEO Roslyn Brandon, in the statement. ”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".

Current sepsis diagnosis is based on the detection of pathogens and can take multiple days. SeptiCyte measures molecular markers from the patient’s immune system rather than relying on the presence of a pathogen, the company said. This allows it to identify infection earlier, more quickly and more accurately than existing tests.

Immunexpress is in discussions with potential partners in the in vitro diagnostics and point-of-care space for the development of automated versions of the test for FDA submission, Brandon said. The company is planning a commercial launch of the SeptiCyte LAB in the second half of this year, she said.