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Immunexpress wins FDA clearance for sepsis tests that could save billions of dollars

Immunexpress has won Food and Drug Administration clearance for a diagnostics test that could save hospitals billions of dollars. The FDA cleared SeptiCyte LAB analysis that tests for sepsis, a life-threatening immune response to infection.
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FDA Clears SeptiCyte™ LAB for Suspected Sepsis Patients

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 (systemic inflammatory response syndrome, or SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission.
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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.
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Immunexpress Receives FDA Clearance for Direct-From-Blood Sepsis Test

Revolutionary diagnostic SeptiCyte™ LAB cleared by FDA for suspected sepsis patients.
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Speedy Sepsis Dx via Molecular Markers

To detect sepsis quickly, says Immunexpress, track the host response, not the pathogens. By Gail Dutton.
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Taking Down The Hospital’s Biggest Killer

By testing white blood cells and monitoring “expression biomarkers,” SeptiCyte – a proprietary technology of Immunexpress – aims to provide faster and more accurate diagnosis of sepsis. By Gregory Zeller.
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Sepsis: 2026

A plenary lecture that took a journey through how we may treat sepsis in 10 years was featured with Steven Opal (Rhode Island Hospital, Providence, RI, USA) stepping up to speak about the expectations, hopes and remaining challenges in the field.
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Seattle biotech Immunexpress eyes up to $40M for Series C round

Seattle biotech Immunexpress is trying to raise up to $40 million in a Series C round that it plans to close by mid-year. By Rachel Nielsen.
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An Interview With Roslyn Brandon from Immunexpress

Dave sits down with Roslyn Brandon from Immunexpress at the JP Morgan Annual Health Conference. In this interview, they discuss the problems of diagnosing sepsis and their innovative solution with SeptiCyte.
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An Interview With Roy Davis from Immunexpress

Dave sits down with Roy Davis from Immunexpress while at the JP Morgan Annual Health Conference. In this video, they discuss a new diagnostic test for detecting sepsis in patients.
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Immunexpress, Collaborators Publish Clinical Validation of Host-Response Sepsis Assay

Immunexpress, Inc., committed to improving outcomes for suspected sepsis patients, announced the publication of the discovery and validation of the SeptiCyte® Lab test for sepsis in PLOS Medicine.
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Immunexpress to Submit Molecular ‘Immune Response’ Sepsis Assay to FDA in May

Immunexpress may finally be close to marketing a clinical test in the US. Having just wrapped up a key clinical trial of its first sepsis assay in around 200 ICU patients, the company plans to submit the test in May to the US Food and Drug Administration and hopes it can...