Unmet clinical need

We address three areas of healthcare calling for innovative solutions:

1. Early infection detection

2. Reducing antimicrobial resistance (AMR)

3. Early sepsis diagnosis

How we drive impact

Our technology can revolutionise healthcare by assisting multiple stakeholders, including:

Patients

by ensuring they receive fast and accurate results

Clinicians

by providing clear information on early infection status and sepsis risk

Healthcare systems

by reducing unnecessary treatments, thereby saving money

Our future

by tackling the AMR crisis head on

Our future

by tackling the AMR crisis head on

“Ruling out the presence of infection is as important as antibiotic development to address antimicrobial resistance.”

– Chris Whitty, Chief Medical Officer for England and Chief Medical Adviser to the UK Government

Early infection detection

The identification of infection is vital for reducing morbidity and mortality as a result of delayed treatment,1 and can help to start patients on appropriate care paths. However, infection is the most common disease state associated with diagnostic uncertainty, leading to delayed diagnosis and mismanagement of healthcare resources.2 Ruling out infection with high certainty in these patients is therefore one of the highest priority unmet clinical needs.3

21-62 % of patients present with diagnostic uncertainty according to numerous studies in hospitals, emergency departments and ICUs.4–9

An unmet diagnostic need in the outpatient clinic includes a test that can accurately rule in or rule out a bacterial infection… with sufficient certainty that antibiotics can be avoided.

– Caliendo et al, 2013.3

Current challenges in managing infection

Patients with presumed infection who are potentially at risk of developing sepsis represent up to 38 % of the UK’s emergency department admissions.1 Ruling out infection is a vital step in their care pathway, but diagnosis is often delayed using traditional methods such as microbial cultures – which can take days for results – or molecular panels that can yield uncertain aetiology.

Clinicians in some countries, including the UK, are advised to assess patients using often inconclusive clinical algorithms, such as National Early Warning Score (NEWS) 2 or Sequential Organ Failure Assessment (SOFA) Score.

This can have a profound effect on the prognosis of these patients, representing a huge gap in their care.

Reducing antimicrobial resistance

The World Health Organisation (WHO) recognises AMR as one of the top 10 global public health threats facing humanity, undermining many of the advances made by modern medicine.10 Many clinicians understandably prescribe antibiotics to avoid missing a curable infectious disease,1 but non-specific use of these therapies is the main driver of the development of drug-resistant pathogens.10

The clinical conundrum: how do clinicians ensure patients receive appropriate antimicrobial therapy when they really need it, while simultaneously being a responsible steward of antibiotics?11

The answer: they need to be guided by evidence to determine the best care path for their patients.

But current tests to diagnose infection and sepsis – and guide subsequent therapy – are limited…1

…until now.

AMR was directly responsible for nearly 1.3 million deaths globally in 2019, and associated with a further five million.12
AMR is projected to result in up to USD 3.4 trillion of GDP losses per year by 2030.13
More than 2.8 million antibiotic-resistant infections occur in the United States each year.14

Early sepsis diagnosis

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.15 It needs to be treated early to avoid potentially high mortality or morbidity. For example, in patients with septic shock, each hour of delay before starting antibiotic treatment is associated with an average decrease in survival of 7.6 %.16 Even though it is one of the most frequent causes of death worldwide,17 the various manifestations of sepsis make diagnosis extremely challenging.18 This leads to inaccuracies in early diagnoses with significant consequences for patients, including inappropriate use of antibiotics, inappropriate management, long-term morbidity or death.18

In 2017, there were nearly 49 million diagnoses and an estimated 11 million sepsis-related deaths globally, representing nearly 20 % of all deaths.12

Relating to patients in intensive care units, one study found that:

  • 30 % of patients initially diagnosed as having sepsis were later reclassified.18
  • 60 % of patients with non-infectious systemic inflammatory response syndrome were wrongly given antibiotics on suspicion of having sepsis.18

  1. Heffernan AJ, Denny KJ. Host Diagnostic Biomarkers of Infection in the ICU: Where Are We and Where Are We Going? Curr Infect Dis Rep. 2021;23(4):1-11. doi:10.1007/S11908-021-00747-0/TABLES/2
  2. Dahm MR, Cattanach W, Williams M, et al. Communication of Diagnostic Uncertainty in Primary Care and Its Impact on Patient Experience: an Integrative Systematic Review. J Gen Intern Med. 2023;38(3):738. doi:10.1007/S11606-022-07768-Y
  3. Caliendo AM, Gilbert DN, Ginocchio CC, et al. Better Tests, Better Care: Improved Diagnostics for Infectious Diseases. Clin Infect Dis. 2013;57(Suppl 3):S139. doi:10.1093/CID/CIT578
  4. Coon ER, Maloney CG, Shen MW. Antibiotic and Diagnostic Discordance Between ED Physicians and Hospitalists for Pediatric Respiratory Illness. Hosp Pediatr. 2015;5(3):111-118. doi:10.1542/HPEDS.2014-0110
  5. Lopansri BK, Miller RR, Burke JP, et al. Physician agreement on the diagnosis of sepsis in the intensive care unit: Estimation of concordance and analysis of underlying factors in a multicenter cohort. J Intensive Care. 2019;7(1):1-17. doi:10.1186/S40560-019-0368-2/FIGURES/5
  6. Caterino JM, Leininger R, Kline DM, et al. Accuracy of Current Diagnostic Criteria for Acute Bacterial Infection in Older Adults in the Emergency Department. J Am Geriatr Soc. 2017;65(8):1802-1809. doi:10.1111/JGS.14912
  7. Filice GA, Drekonja DM, Thurn JR, et al. Diagnostic Errors that Lead to Inappropriate Antimicrobial Use. Infect Control Hosp Epidemiol. 2015;36(8):949-956. doi:10.1017/ICE.2015.113
  8. Klouwenberg PMCK, Ong DSY, Bos LDJ, et al. Interobserver agreement of centers for disease control and prevention criteria for classifying infections in critically ill patients. Crit Care Med. 2013;41(10):2373-2378. doi:10.1097/CCM.0B013E3182923712
  9. Roger PM, Martin C, Taurel M, et al. Motives for the prescription of antibiotics in the emergency department of the University Hospital Center in Nice. A prospective study. Presse Med. 2002;31(2):58-63. PMID: 11850986
  10. Antimicrobial resistance. (2023) https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance. Accessed July 22, 2024
  11. Sabo SR, Venkatramanan A, Shorr AF. At the Intersection of Critical Care and Infectious Diseases: The Year in Review. 2024;12(3):562. doi:10.3390/biomedicines12030562
  12. Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020;395(10219):200-211. doi:10.1016/S0140-6736(19)32989-7
  13. World Bank Group. (2017) Drug-resistant infections: a threat to our economic future (Vol. 2): final report. https://documents.worldbank.org/en/publication/documents-reports/documentdetail/323311493396993758/final-report. Accessed July 10, 2024
  14. Centers for Disease Control and Prevention. (2019) Antibiotic Resistance Threats in the United States, 2019. https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html. Accessed July 22, 2024
  15. Singer M, Deutschman CS, Seymour C, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8):801. doi:10.1001/JAMA.2016.0287
  16. Kumar A, Roberts D, Wood KE, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006;34(6):1589-1596. doi:10.1097/01.CCM.0000217961.75225.E9
  17. Fleischmann-Struzek C, Rudd K. Challenges of assessing the burden of sepsis. Med Klin Intensivmed Notfmed. 2023;118(2):68-74. doi:10.1007/S00063-023-01088-7/FIGURES/2
  18. Lopansri BK, Miller RR, Burke JP, et al. Physician agreement on the diagnosis of sepsis in the intensive care unit: estimation of concordance and analysis of underlying factors in a multicenter cohort. J Intensive Care. 2019;7(1). doi:10.1186/S40560-019-0368-2