Sepsis continues to be a serious threat to patients globally. Recent studies estimate that more than 30 million people are impacted worldwide every year and may be implicated in 6 million deaths,1 David Dolinger, VP Product Realisation at QuantuMDx Group Limited, told MD+DI.
Infection and drug resistance contribute significantly to sepsis risks. In neonatal care alone, it is estimated that one million newborn deaths each year are associated with maternal infection, such as maternal sepsis,2 pointed out Dolinger. And three out of every ten deaths because of neonatal sepsis are thought to be caused by resistant pathogens,3 he added.
Last year, QuantuMDx and Ontera Inc. began collaborating on a next-generation solution for blood stream infection and drug resistance detection. The solution will draw from QuantuMDx’s rapid cell/sample preparation technology, CAPTURE-XT, as well as Ontera’s nanopore biosensor, currently utilized in their SAM and DUO Nano platforms.
“The combined technologies will be utilized to concentrate the causative etiological agent(s) and then to identify and provide an initial susceptibility/resistance profile for the causative agent(s),” he said. “The solution will not detect biomarkers but will specifically concentrate and detect the causative agent(s).”
Dolinger said that the approach is “addressing the diagnostic gaps and focusing on an area normally overlooked, that of preanalytical processing of the specimen to enhance sensitivity and specificity. The CAPTURE-XT technology provides the ability to rapidly capture and concentrate organisms of interest from an adequate volume of specimen. It should be remembered that for certain sepsis causing pathogens as little as 5 organisms/mL of blood is required for sepsis to occur. This front-end ability to concentrate potential targets is what has limited sepsis diagnostics previously.”
In addition, “Ontera’s nanopore molecular detection and quantification technology platform, SAM, will work in coordination with the CAPTURE-XT technology to enable this diagnostic tool to serve as an accurate, affordable, and integrated platform that detects bloodstream infections rapidly, at the point of need,” he added.
The solution will be designed for a quick response to sepsis signs and symptoms. “The solution will be a combined platform that can be utilized in satellite labs and not technically at the bedside,” Dolinger said. “These satellite labs still provide the rapid turnaround times required to effectively treat the individual. We are currently estimating and developing for specimen collection and transport to results will occur in less than 1 hour of an adequate primary specimen being taken. The current care management pathways for individuals presenting with sepsis calls for the prompt administration of antibiotics empirically. The key for a rapid sepsis diagnostic solution is for accurate and actionable data output to guide the care management pathway. That is ensuring that the causative etiological agent is identified (i.e., bacterial, [gram-positive or gram-negative], fungal, viral or parasitic). In addition, it is critical to provide an initial antibiogram or susceptibility/resistance profile.”
When asked how the system would detect resistance to the drugs that target those pathogens, Dolinger said that “detection of resistance is a critical feature for any diagnostic that is aimed at sepsis. The solution will also be providing information concerning susceptibility/resistance. However, no one technology can address all methods and modes of drug resistance in a rapid manner. The assay will provide guidance to ensure that the proper treatment is not empirically based but is based upon actionable information.”
Added Murielle Thinard McLane, CEO of Ontera, in a news statement: “Today, 30% of patients receive inappropriate antimicrobial therapy. By not only identifying sepsis but also resistance to most common antibiotics in less than 30 minutes, we will transform the sepsis landscape and impact lives. We have set out on a mission to democratize access to molecular information to create a more sustainable planet. This collaboration with QuantuMDx is a major proof point along that mission.”
- Fleischmann C, Scherag A, Adhikari NK, et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med 2016; 193(3): 259-72. https://www.ncbi.nlm.nih.gov/pubmed/26414292
- Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). In: Black RE, Laxminarayan R, Temmerman M, Walker N, eds. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank(c) 2016 International Bank for Reconstruction and Development / The World Bank.; 2016. https://www.ncbi.nlm.nih.gov/pubmed/27227205
- Laxminarayan R, Matsoso P, Pant S, et al. Access to effective antimicrobials: a worldwide challenge. Lancet 2016; 387(10014): 168-75. https://www.ncbi.nlm.nih.gov/pubmed/26603918