Data Demonstrate the Performance of SeptiCyte® RAPID is Unaltered by Patient Malignancy or Treatment with Anti-neoplastics or Immunosuppressants
Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced a research snapshot presentation of clinical data demonstrating the performance of SeptiCyte® RAPID in adult and pediatric patients with sepsis or systemic inflammation and either hematological malignancy, metastatic malignancy, or those treated with anti-neoplastic or immunosuppressive therapies, at the Society of Critical Care Medicine’s (SCCM) 50th Annual Critical Care Congress taking place virtually from Jan. 31 through Feb. 12, 2021.
“Sepsis is a dysregulated immune response to infection that occurs when an infection overstimulates white blood cells, which can lead to morbidity and mortality,” said Roy Davis, M.D., Ph.D., MHA, Chief Medical Officer of Immunexpress. “These data demonstrate the ability of SeptiCyte® RAPID to distinguish between sepsis and SIRS in adults and children with compounding conditions and treatments. They reinforce the utility of our technology as a rapid diagnostic, generating actionable results in about an hour, with the potential to allow physicians to make critical treatment decisions faster than the traditional culture method.”
Rolland Carlson, Ph.D., Chief Executive Officer of Immunexpress, added, “Any infection can lead to sepsis, and patients with sepsis can have compounding conditions, as demonstrated from the data set used in this study. This robust data set demonstrate the diagnostic value of SeptiCyte® RAPID with no change in performance in patients with sepsis and hematological malignancy, metastatic malignancy and those treated with anti-neoplastics or immunosuppressives.”
SeptiCyte® RAPID host immune response assay uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation. Immunexpress evaluated the performance of SeptiCyte® RAPID using well characterized biobanked clinical samples, from collaborators at Academic Medical Center and Utrecht Medical Center, Netherlands, and Seattle Children’s Hospital, U.S. The study used samples from adults with either sepsis or systemic inflammatory response syndrome (SIRS) with either hematological malignancy (HM), metastatic malignancy (MM), or were treated with corticosteroid or anti-neoplastic therapies. Diagnostic performance using the area under the receiver operation characteristic curve (ROC-AUC) results in adult sepsis cases demonstrated AUC’s of ≥ 0.88 in HM, MM and with anti-neoplastic therapies. The pediatric study used samples from patients with either post cardiopulmonary bypass (PCPB) or with clinical severe sepsis syndrome (CSSS). Diagnostic performance in pediatric patients demonstrated AUC’s of ≥ 0.96 regardless of antineoplastic/immunosuppressant drug treatment or malignancy disease status.
Immunexpress is a molecular diagnostic company, based out of Seattle, committed to improving outcomes for patients suspected of sepsis. Immunexpress’ SeptiCyte® technology can assess a patient’s dysregulated immune response by quantifying and analyzing gene expression from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the Biocartis’ Idylla™ platform*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis; diagnosing bacterial sepsis, viral sepsis, or fungal infections. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.
In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a commercialization partnership with Biocartis in Europe.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
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