EDTA blood collection tubes are used routinely in clinical settings for hematology procedures around the world
SeptiCyte RAPID is a sample-to-answer, cartridge-based, host response molecular test. (Credit: Hush Naidoo Jade Photography on Unsplash)
Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with SeptiCyte RAPID.
The updated SeptiCyte RAPID cartridges add undiluted EDTA blood as a validated sample type within the U.S. healthcare market and have been available on the European market since August 2022.
“As an investigator in the U.S. clinical validation study of EDTA cartridges with SeptiCyte RAPID, my team appreciates how this sample collection will increase the utility of SeptiCyte RAPID,” commented Kenneth E. Remy, MD, MHSc, MSCI, FCCM, Center Director, the Blood, Heart, Lung, and Immunology Research Center and the Ellery Sedgwick, Jr. Chair and Distinguished Scientist in Cardiovascular Research at University Hospitals and UH Rainbow Babies & Children’s in Cleveland/Case Western Reserve University. “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.”
“The ability to utilize undiluted EDTA blood samples with SeptiCyte RAPID in the U.S. healthcare system will improve ease-of-use in the clinical setting,” said Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. “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 were previously validated in a multi-site study conducted at University Hospitals in Cleveland/Case Western Reserve University and other healthcare systems. Their implementation allows for the use of standard EDTA blood collection tubes in place of proprietary PAXgene blood RNA tubes.
This research was in part funded by Contract #75A50120C00125 from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). BARDA awarded this grant to Immunexpress in 2020 as part of the DRIVe Solving Sepsis program.
Source: Company Press Release