Immunexpress, Pty Ltd. has announced the US Food and Drug Administration (FDA) clearance for the use of EDTA blood-compatible cartridges with SeptiCyte RAPID®. 

These updated cartridges, which have been available in the European market since August 2022, validate undiluted EDTA blood as a sample type within the US healthcare market.

The inclusion of undiluted EDTA blood as a validated sample type is expected to enhance the utility of SeptiCyte RAPID® in the US clinical setting. 

Dr. Kenneth E. Remy, Center Director at the Blood, Heart, Lung, and Immunology Research Center, commented on the potential impact of this advancement in sepsis diagnosis, "Sepsis is a condition that rapidly progresses, and early diagnosis has the potential to influence patient outcomes. EDTA-anticoagulated blood samples broaden the ability to utilize available clinical samples in at-risk patients for faster collection and processing of patient samples so clinicians may make actionable decisions for the course of care of suspected sepsis patients."

Rollie Carlson, Ph.D., CEO of Immunexpress, emphasized the significance of this development for clinical use and said, "The ability to utilize undiluted EDTA blood samples with SeptiCyte RAPID in the US healthcare system will improve ease-of-use in the clinical setting. The updated SeptiCyte® RAPID EDTA cartridges add additional utility to our diagnostic technology by allowing the use of small volumes of blood with minimal processing required and will promote wider adoption in healthcare systems across the US"

The EDTA cartridges underwent validation in a multi-site study conducted at University Hospitals in Cleveland/Case Western Reserve University and other healthcare systems. They enable the use of standard EDTA blood collection tubes, providing flexibility in sample collection compared to proprietary PAXgene® blood RNA tubes.

This research was partially funded by Contract #75A50120C00125 from the Biomedical Advanced Research and Development Authority (BARDA), a part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS). BARDA awarded this grant to Immunexpress in 2020 as part of the DRIVe Solving Sepsis program.