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Article

A Multi-mRNA Host-Response Molecular Blood Test for the Diagnosis and Prognosis of Acute Infections and Sepsis: Proceedings from a Clinical Advisory Panel

1
Department of Medicine, McMaster University, Hamilton, ON L8S 4L8, Canada
2
Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN 37220, USA
3
Department of Medicine, Division of Emergency Medicine and Department of Surgery, Washington University, St. Louis, MO 63110, USA
4
Department of Pathology, Medical College of Wisconsin, Milwaukee, WI 53226, USA
5
Inflammatix Inc., Burlingame, CA 94010, USA
6
Department of Emergency Medicine, The Johns Hopkins University, Baltimore, MD 21264, USA
*
Author to whom correspondence should be addressed.
These authors equally contributed to the manuscript.
J. Pers. Med. 2020, 10(4), 266; https://doi.org/10.3390/jpm10040266
Received: 1 October 2020 / Revised: 12 November 2020 / Accepted: 2 December 2020 / Published: 7 December 2020
(This article belongs to the Special Issue Personalized Diagnosis and Treatment of Patients with Sepsis)
Current diagnostics are insufficient for diagnosis and prognosis of acute infections and sepsis. Clinical decisions including prescription and timing of antibiotics, ordering of additional diagnostics and level-of-care decisions rely on understanding etiology and implications of a clinical presentation. Host mRNA signatures can differentiate infectious from noninfectious etiologies, bacterial from viral infections, and predict 30-day mortality. The 29-host-mRNA blood-based InSepTM test (Inflammatix, Burlingame, CA, formerly known as HostDxTM Sepsis) combines machine learning algorithms with a rapid point-of-care platform with less than 30 min turnaround time to enable rapid diagnosis of acute infections and sepsis, as well as prediction of disease severity. A scientific advisory panel including emergency medicine, infectious disease, intensive care and clinical pathology physicians discussed technical and clinical requirements in preparation of successful introduction of InSep into the market. Topics included intended use; patient populations of greatest need; patient journey and sample flow in the emergency department (ED) and beyond; clinical and biomarker-based decision algorithms; performance characteristics for clinical utility; assay and instrument requirements; and result readouts. The panel identified clear demand for a solution like InSep, requirements regarding test performance and interpretability, and a need for focused medical education due to the innovative but complex nature of the result readout. Innovative diagnostic solutions such as the InSep test could improve management of patients with suspected acute infections and sepsis in the ED, thereby lessening the overall burden of these conditions on patients and the healthcare system. View Full-Text
Keywords: acute infections; sepsis; bacterial; viral; diagnosis; prognosis; point-of-care; emergency medicine acute infections; sepsis; bacterial; viral; diagnosis; prognosis; point-of-care; emergency medicine
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MDPI and ACS Style

Ducharme, J.; Self, W.H.; Osborn, T.M.; Ledeboer, N.A.; Romanowsky, J.; Sweeney, T.E.; Liesenfeld, O.; Rothman, R.E. A Multi-mRNA Host-Response Molecular Blood Test for the Diagnosis and Prognosis of Acute Infections and Sepsis: Proceedings from a Clinical Advisory Panel. J. Pers. Med. 2020, 10, 266. https://doi.org/10.3390/jpm10040266

AMA Style

Ducharme J, Self WH, Osborn TM, Ledeboer NA, Romanowsky J, Sweeney TE, Liesenfeld O, Rothman RE. A Multi-mRNA Host-Response Molecular Blood Test for the Diagnosis and Prognosis of Acute Infections and Sepsis: Proceedings from a Clinical Advisory Panel. Journal of Personalized Medicine. 2020; 10(4):266. https://doi.org/10.3390/jpm10040266

Chicago/Turabian Style

Ducharme, James, Wesley H. Self, Tiffany M. Osborn, Nathan A. Ledeboer, Jonathan Romanowsky, Timothy E. Sweeney, Oliver Liesenfeld, and Richard E. Rothman 2020. "A Multi-mRNA Host-Response Molecular Blood Test for the Diagnosis and Prognosis of Acute Infections and Sepsis: Proceedings from a Clinical Advisory Panel" Journal of Personalized Medicine 10, no. 4: 266. https://doi.org/10.3390/jpm10040266

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