Technology & Market

Presymptom Health estimates that the market size for its tests is up to 250M tests/year associated with 49 million annual Sepsis diagnoses. In the UK alone, there is an estimated 1.9M suspicion of Sepsis hospital admissions/year.

Diagnostic Tests

The key difference between our tests and the competition is that we seek to identify the patient’s response to the disease as opposed to detecting the pathogen. This is an important differentiator because Sepsis is essentially a host-mediated syndrome (indeed, the definition of sepsis is “life-threatening organ dysfunction resulting from the dysregulated host response to an infection”). Notwithstanding an initial focus on host response tests, Presymptom also has active programs based on phenotypic risk profile assessment and confirmation of the presence of infection. The latter program is intended to help support the clinical decision to administer antimicrobial therapy.

Presymptom has a plan to extend its clinical diagnostic test portfolio to include tests for both point-of-care and central laboratories. Our early development programmes are focused on the development of presymptomatic tests to determine the presence of infection and the future onset of Sepsis. By identifying the 10-20% at risk of deterioration before symptoms present, our tests will:

• Allow clinicians to discharge patients with confidence (if low risk of deterioration)
• Identify patients with infection requiring antimicrobial therapy
• Enhance triage of patients to appropriate level of care and acute monitoring (general/COVID ward, step-up or ICU admission)
• Facilitate early administration of Sepsis standard of care support bundle in high-risk patients: intravenous broad-spectrum antimicrobials, fluid support, supplemental oxygen, vasopressors
• Identify subset most in need of investigational and/or high risk/cost therapies:
  • Anti-inflammatories: dexamethasone
  • Immune-modulating therapy: interferon-beta, IL6 & IL1 antagonists and inhibitors, neutralizing monoclonals, immunoglobulin
  • Intravenous anti-viral and anti-bacterial therapy: remdesavir, oseltamivir, lopinavir/ritonavir; azithromycin
  • Other mechanisms of action: hydroxychloroquine, convalescent plasma, angiotensin-II receptor antagonists
• In crisis/pandemic peak demand “waves”, support allocation of scarce resources (ventilators, critical care bed space)

Sepsis Lab Tests

The Sepsis Lab Tests will be ultra-high accuracy central laboratory tests and offered on multiple systems.

The Presymptom Sepsis Lab Tests will initially run on a number of “open” clinical systems manufactured by third parties. In addition, certain tests may be offered on proprietary molecular diagnostic platforms, for which we may partner with industry leaders.

Initial funding and support has been secured to progress the first molecular tests to the prototyping stage and to develop first proof of concept data.

Sepsis Point-of-Care

The Sepsis Point-of-Care test will be a high-accuracy low-cost test to support Emergency Department triage.

Based on protein biomarker technology, it will use an OEM-derived platform technology approach designed to optimise ease of use and test cost. We may also partner with industry leaders with an interest in adding high-value content to their platforms.

These tests will find particular utility in Emergency Departments considering admission of patients with Suspicion of Sepsis and (over time) in primary care settings where referral to the Emergency Department is under consideration.