A Paradigm Shift in Medical Microbiology
How Noscendo’s digital diagnosis can save lives and reduce costs
By Rainer Christine, Partner, Earlybird Health
When Earlybird led Noscendo’s series A financing in February 2020, the company had not yet entered the market and was focused almost exclusively on improving diagnostics for sepsis patients. A lot has happened since but first – let’s talk about sepsis.
What is Sepsis?
Sepsis, or blood poisoning, is a life-threatening systemic infection in which bacteria or other infectious agents have entered a person’s bloodstream. Even in countries with good healthcare systems, mortality rates are very high: about 30%, and another 40% of patients survive with long-lasting side effects, such as kidney failure. This is disastrous for patients and also for healthcare systems, which have to bear the costs for intensive care and for supporting patients that retain life-long impairments. From a global perspective the situation is even worse. The WHO estimates that one out of five deaths is attributable to sepsis.¹
‘This is disastrous for patients and also for healthcare systems, which have to bear the costs for intensive care and for supporting patients that retain life-long impairments.’
Major Challenges in Treatment
A major challenge in treating sepsis is accurate and fast identification of the causative microbe. With current methods, however, diagnosing the infectious agent and thus homing in on the treatment is impeded in several respects:
Firstly, all current methods depend on certain assumptions as to which bacterium, virus, fungus or parasite might be clinically relevant. In most cases, some of the patient’s blood is added to culture medium and incubated for several days, a process that essentially hasn’t changed in a hundred years. The hope being that the relevant infectious agent will multiply and be amenable to identification. Unfortunately, many clinically relevant agents do not grow in culture.
Even more modern diagnostic approaches, mostly PCR-based assays, depend on assumptions regarding the potential identity of the microbe. (As a reminder, the polymerase chain reaction method, or PCR, amplifies a small amount of DNA to be large enough to study.) These approaches can give a yes/no answer per question asked or assay performed but they cannot find a bug outside of these predefined boundaries.
Secondly, sepsis is an acute infection and can exacerbate very rapidly, including leading to patient death. Running blood cultures for days is fundamentally incompatible with the rapid diagnosis needed to deliver results in time to provide the best help to patients.
Noscendo’s Different Approach
Noscendo’s approach, called DISQVER, to identifying the infectious agent causing sepsis is very different. A few milliliters of the patient’s blood from a standard blood draw are used to isolate cell-free DNA (cfDNA), which is a reliable reflection of any microbial activity in a patient. The power of cfDNA has only been known for a few years. After isolation, the cfDNA is sequenced, the data uploaded into the cloud and compared against a large database of microbial DNA. Noscendo has developed proprietary algorithms that permit the identification of the clinically relevant infectious agent against the background of other microbial and human DNA.
The diagnostic results are then directly provided to the existing infrastructure in the hospital, enabling a seamless journey for the treating physician. Importantly, as results don’t depend on the time-consuming culture of microbes, Noscendo is able to provide guidance to the clinician within 24 hours — blood draw in the morning, results by the next morning — a key advantage for any patient management strategy. And even same-day results will become available in the foreseeable future.
Health Insurers Say ‘This edge can saves lives.’
Noscendo’s platform has met with tremendous interest from payers and clinicians. The prestigious German Federal Joint Committee, representing all public health insurers, hospitals and physicians, has awarded a grant to a syndicate consisting of Noscendo, three of the top German health insurers and twenty maximum-care hospitals, the ‘who is who’ of Germany’s intensive care medicine. The three health insurers, Techniker, BARMER, AOK Rheinland-Hamburg, (respectively numbers one, two and eight in the German market), represent c. 25 million insurees out of Germany’s population of c. 83 million. The study financed by the grant — DigiSep — will demonstrate the health economic impact and benefit of Noscendo’s DISQVER in sepsis.
Notably, the study was publicly announced on September 13, World Sepsis Day, and officially supported by the CEOs of all three insurers. Here’s what the health insurers had to say about significant opportunities in digital diagnostics:
“Society knows too little about the frequency and severity of sepsis and also knows too little about the relatively high death rate of approx. one third of people affected. With our involvement in DigiSep, we want to make an important contribution to increasing the focus on this severe disease and to making progress in disease management”, Prof. Dr. med Christoph Straub, BARMER’s CEO, explains.
“Treating sepsis critically depends on fast analysis und fast intervention. The DigiSep project’s digital technology creates the crucial edge for the team of treating physicians in their race against time. This edge can save lives”, TK’s CEO Dr. Jens Bass adds. Matthias Mohrmann, Member of the Board of AOK Rheinland/Hamburg, agrees with this assessment, “Every second counts for treating sepsis. The earlier and the more precise a statement can be made about the nature of the infection, the faster life-saving measures can be taken and human lives saved.”
“Society knows too little about the frequency and severity of sepsis and also knows too little about the relatively high death rate…we want to make an important contribution to increasing the focus on this severe disease and to making progress in disease management.” -Barmer’s CEO
More importantly even, DISQVER was launched into the German market in early 2020, while ICUs were struggling with the COVID pandemic’s first wave, and has since seen significant adoption by clinicians. Since market introduction, two key trends for its usage have emerged. First, clinicians are using DISQVER for many more than sepsis patients, e.g. in hemato-oncology and various other contexts where infection plays a role. Secondly, for a significant proportion of patients, physicians are using DISQVER’s information from more than one body fluid. Apart from blood, for example, they request the analysis of lung lavage or cerebrospinal fluid in an attempt to trace the patient’s infection to its origin and to provide optimal treatment.
‘The universe of relevant infectious agents may be much larger than has so far been visible.’
Samples from hemato-oncology patients have revealed that it is particularly hard to guess the relevant microbe in patients with impaired immune systems. In one case, a bloodstream infection in a cancer patient was caused by bread mold, something that wouldn’t happen in an otherwise healthy person and something impossible to anticipate for the treating physician. The universe of relevant infectious agents may be much larger than has so far been visible.
A New Chapter for Medical Microbiology
Now, Noscendo is opening a new chapter for the entire space of medical microbiology, in terms of identifying the relevant infectious agent at unprecedented speed in a hypothesis-free manner and by connecting medical insights, e.g. from different body fluids of the same patient. This is already leading to better treatment for patients right now, lives saved and costs reduced.
With the capital currently being raised, Noscendo will expand its commercial activities in Europe and beyond, and continue to execute on its product roadmap to offer a comprehensive portfolio for medical microbiology — and for patients suffering from infections.
