Sepsis, a potentially life-threatening condition triggered by the body's extreme response to an infection, demands prompt and comprehensive treatment. Timely intervention is crucial, as sepsis can progress rapidly, leading to organ failure and death. The primary approach to sepsis treatment involves antibiotics to target the underlying infection, alongside supportive therapies to stabilize the patient's vital functions. Intravenous fluids are administered to maintain blood pressure, and in severe cases, vasopressors may be employed to further support circulation.

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Early recognition of sepsis symptoms is vital for swift intervention. However, as per Dr Flavia Huygens, the Executive Director, Co-Founder and Chief Scientific Officer at Queensland based biotech company Microbio, the current ‘gold standard’ method to identify the causative pathogen is a slow, two-step blood culturing and identification process that takes between 12 hours and 5 days and has limited sensitivity.

Microbio has developed groundbreaking InfectID solution — a rapid and targeted diagnostic tool that leverages existing PCR instruments to revolutionize pathogen detection and identification. By providing clinicians with actionable intelligence, InfectID empowers them to deliver precise antimicrobial treatment, potentially mitigating the escalating threat of antimicrobial resistance (AMR) – a pressing global health concern. 

InfectID attained Central Drugs Standard Control Organization (CDSCO) clearance in India in December 2023, due to the fact that the InfectID kit detects 95 per cent of sepsis-causing pathogens within a remarkable 3-hour timeframe, thus saving lives and enhancing patient outcomes. Dr Huygens, explained the workings and path-breaking tehnology behind the diagnostic tool in an email interview. Here are the excerpts —

 

Q: Can you explain the science behind InfectID and its advantage over traditional blood culture methods?

A: "To identify the pathogens causing sepsis using blood culture, the pathogens must ‘grow’ and multiply outside the body in a laboratory. This needs a substantial volume of blood, many hours and frequently fails if the nutrients and environment provided in the laboratory are not perfectly matched to the pathogens’ requirements. InfectID-BSI uses a molecular diagnostic method to detect the genetic signatures of 26 common sepsis-causing pathogens. This is rapid, needs a much smaller volume of blood and does not require the pathogens grow."

"The science — sepsis is a common condition with high morbidity and mortality (Rudd et al., 2020). Blood culture is the current gold standard test used for laboratory diagnosis of sepsis (Dellinger et al., 2013), which has several disadvantages. From a clinical perspective, sometimes a diagnosis of sepsis is obvious. However, in other circumstances, especially when onset is more insidious, diagnosis is often missed. Many patients require critical care and early diagnosis, and prompt treatment is essential as each hour delay in administering antibiotics increases the risk of death by 9% (Liu et al., 2017). Blood culture's conventional pathogen identification method is time consuming, requiring 12 hours to 5 days (for yeast species) due to the need to culture the pathogen before it can be identified (Schwarzenbach et al., 2019; Orellana et al., 2020; Baron et al., 2005). Blood cultures are frequently negative (80–89% of the time) even though other tests and clinical signs suggest sepsis (Previsdomini et al., 2012). Blood culture requires significant blood volume (typically 2–3 sets, amounting to 40–60 mL of blood taken at multiple time points) (Henning et al., 2019; Lee et al., 2007). This can be difficult to obtain from patients with co-morbidities, and from paediatric patients and neonates (Woodford et al., 2021). Blood culture provides an in vitro culture environment where BSI-associated bacteria with fastidious growth conditions (that is, complex or restricted nutritional and/or environmental requirements) are difficult to detect (Rello et al., 2018)."

Microbio’s InfectID-BSI test detects, identifies and quantifies microbial pathogens directly from blood. The key features of InfectID-BSI include:

• Runs on whole blood: No need to culture the blood before running the tests

• Rapid: Results in < 3 hours (depending on the real-time Polymerase Chain Reaction (qPCR)device used)

• Sensitive: Detects pathogens in the blood when there are only a few pathogen cells present

• Specific: The 26 most common BSI/sepsis-causing pathogens are unambiguously identified

• Economical: Runs on open hardware platform, no need to purchase proprietary equipment

• Targets pathogens prevalent in India: The 17 most prevalent pathogens known to cause BSI and sepsis in India are detected by InfectID-BSI

Q: How will InfectID-BSI specifically improve patient outcomes for those with sepsis?

A: "Clinicians cannot effectively treat bloodstream infections and sepsis until the pathogen causing them is known. Sepsis is a life-threatening illness caused by the body’s reaction to a bloodstream infection (BSI). It affects 49 million people and is responsible for 11 million deaths every year globally which equates to more than three people dying from sepsis every second (World Health Organisation, 2020). Treatment involves administering antimicrobials to kill or inhibit the growth of the pathogen causing the infection. For every hour of delay in administering effective antimicrobial treatment, mortality rates increase substantially (Kumar, 2006). The current ‘gold standard’ method to identify the causative pathogen is a slow, two-step blood culturing and identification process that takes between 12 hours and 5 days and has limited sensitivity (Lambregts, 2019)."

"InfectID-BSI is an In Vitro Diagnostic (IVD) test that informs clinicians which BSI pathogen to treat in less than 3 hours, significantly improving patient outcomes. The InfectID-BSI test unlocks the potential for early BSI/sepsis diagnosis and earlier use of optimal antimicrobials, which is likely to reduce the length of hospital stays and consequently health-care costs."

 

Q: What are your expectations for the commercialization of InfectID-BSI in India?

A: "We have great expectations for the commercial success of our breakthrough InfectID-BSI product in India. We are engaged in commercial evaluations currently with leading hospital groups and planning for more in India now. There is considerable interest in the test and the potential lifesaving impact that InfectID-BSI can make on improving the outcomes for patients with blood stream infections and potential sepsis. We also have significantly interested clinical diagnostic distribution partners in India, quite interested in making the product broadly available in India and we are working through those details at present."

 

Q: What are your thoughts on the current state of diagnostic innovations for blood infections and sepsis in India?

A: "Sepsis is a complex disease that requires clinicians from multiple disciplines to diagnose and manage effectively. The standard of care in India is blood culture, which is the same around the globe. There are several emerging innovations that may assist in the diagnosis of sepsis, including Artificial Intelligence (AI) tools and biomarker tests. These will complement InfectID-BSI, which gives the clinicians the information they need to effectively treat the underlying infection that is causing sepsis."

 

Q: In your opinion, what key challenges and opportunities does the life sciences industry face in addressing global health challenges like sepsis?

A: "Sepsis disproportionally affects low to middle-income countries (LMICs) where infrastructure is still developing. Key challenges include obtaining high-quality data about the prevalence of sepsis. With this data, governments and the life sciences industry can more equitably build capacity and capability to diagnose and manage sepsis in the populations most affected - especially new mothers, babies, and children in LMICs."


Q: What strategies are in place to ensure the financial sustainability and scalability of InfectID-BSI in India?

A: "We realize and understand that the Indian healthcare industry is quite different to other healthcare environments and has unique requirements when it comes to costs, distribution and the scale of potential testing and being able to make these advances available to a large and fragmented population, many of which do not have high disposable incomes available to spend on advanced healthcare solutions. Our commercial offering in India will reflect these unique challenges and we will also look to potentially establish localized manufacturing and supply chain options to better meet local needs and requirements. We have plans already in place to address these unique challenges."