September 15, 2020
Immunexpress, Inc., a medical diagnostic company focused on improving outcomes for suspected sepsis patients, today announced the presentation of analytical and clinical performance data for SeptiCyte® technology in two posters at the virtual e-ISICEM (International Symposium on Intensive Care and Emergency Medicine), from Sept. 15-18, 2020.
Immunexpress notes the first poster, titled “Clinical Performance of a Rapid Sepsis Test on a Near-Patient Molecular Testing Platform,” details the clinical validation of SeptiCyte® RAPID. The study compares Immunexpress’ rapid version of the SeptiCyte® assay on the Biocartis Idylla™ platform to SeptiCyte® LAB in patients located in the U.S. and Europe. The data demonstrates comparable and reproducible results between SeptiCyte® LAB and SeptiCyte® RAPID to differentiate sepsis from non-infectious systemic inflammation (SIRS). The abstract (P481) can be found here and the full poster can be found here.
James Kirk, Ph.D., Director of Product Development at Immunexpress and lead author on the poster, stated, “By validating SeptiCyte® RAPID on the Idylla™ platform, we have demonstrated that our high-performance test can be delivered in a sample-to-answer format that addresses urgent and unmet needs in sepsis diagnostics. The SeptiCyte® technology has already been approved by regulatory agencies via SeptiCyte® LAB. This is the first validation of a rapid, near-patient, fully-integrated, reproducible, immune response-based sepsis diagnostic. With SeptiCyte® RAPID, we can now provide actionable results to clinicians in approximately one hour for critically-ill patients suspected of sepsis, where every second counts.”
SeptiCyte® LAB was translated to the Biocartis Idylla™ near-patient testing platform and analytically validated. Blood samples were collected from patients (N = 195) previously enrolled into prospective, observational clinical studies conducted in the U.S. and Europe. SeptiCyte® RAPID results were reported as a SeptiScore® between 0 and 15 with higher scores representing higher probability of sepsis. SeptiScore® results generated by SeptiCyte® RAPID were compared to scores generated by SeptiCyte® LAB for the U.S. cohort.
For 195 cartridges run, the average technician hands-on-time (HoT) was 2 minutes, average turnaround time (TaT) was 65 minutes, and coefficient of variation for a positive extraction control was 1.19% demonstrating repeatability. Correlation of SeptiScore® values between SeptiCyte® LAB and SeptiCyte® RAPID, based upon a subset of N = 100 samples run on both platforms, was very high (r2=0.94).
Immunexpress announced its partnership with Biocartis in 2018 to develop and commercialize this fully automated SeptiCyte® technology for use on the Biocartis’ real-time PCR Idylla™ machine. SeptiCyte® LAB was the first-in-class sepsis diagnostic to gain FDA clearance (K163260) but workflow and ease of use weren’t optimized. So SeptiCyte® RAPID utilizing the same gene technology as SeptiCyte® LAB was been applied to the Idylla™ system and delivers actionable results in approximately one hour.
The second poster, titled “Accuracy of SeptiCyte® for Diagnosis of Sepsis Across a Broad Range of Patients,” explores the accuracy of SeptiCyte® for diagnosis of sepsis across a broad range of patients. These new data include patients in the ICU, hospital ward and emergency department and also neonate, pediatric and adult patients. The study results show that diagnosis with SeptiCyte® was comparable across both patient category and hospital location. The abstract (P482) can be found here and the full poster can be found here.
Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress, stated, “Our study findings demonstrate that SeptiCyte® immune-response sepsis diagnostic technology performs across a broad range of patients. Similar diagnostic performances in adult and pediatric patients, across both hospital locations and with carious sepsis etiologies, suggests that the SeptiCyte® signature has broad diagnostic utility in this heterogenous sepsis patient population. The SeptiCyte® signature has been translated to the near-patient Biocartis Idylla™ platform, which promises diagnosis of sepsis in approximately one hour in a broad patient population.”
The purpose of the study was to demonstrate diagnostic performance of the SeptiCyte® technology across a broad range of patients, including adults, children and neonates, and in hospital locations outside the ICU. Diagnostic performance was determined using Area Under Curve (AUC). SeptiCyte® AUCs for the three groups of adults, pediatric/neonates and adult/pediatric and were 0.88, 0.87, and 0.85 respectively, which is similar to that previously reported for adults only (0.82 – 0.89). The full data from the poster demonstrate promising differentiation of adult patients with sepsis from those with non-infectious systemic inflammation, and from healthy subjects with diabetes using SeptiCyte® biomarkers.