Our Lead Program

iNOS Sepsis Diagnostic: From Science to Clinical Use

Our development priority is a blood-based iNOS host-response diagnostic designed to support earlier sepsis detection. The path to market centers on clinical evidence, practical hospital workflows, and a focused initial launch.

Lead Program In Development

iNOS Host-Response Diagnostic

Initial focus: earlier sepsis detection

Inducible nitric oxide synthase (iNOS), associated with circulating extracellular vesicles, is the lead candidate biomarker. The aim is to translate this biological signal into a quantitative blood test that adds useful information to the assessment of patients at risk of sepsis.

Biological target
Vesicle-associated iNOS, described in published research as microvesicle-associated iNOS (MV-A iNOS).
Intended clinical role
Support earlier recognition alongside clinical assessment, established biomarkers, and pathogen testing.
Development priority
Establish assay reliability, clinical performance, and value in the intended care setting.
Explore the iNOS science
Path to Market

Build the Evidence. Prepare for Adoption.

The proposed development roadmap below describes the work needed to reach clinical use. It does not indicate completed milestones or fixed launch dates; activities may overlap as the program develops.

  1. Define the Initial Use Case

    Refine the intended patient population, clinical decision, sample requirements, and target turnaround time with hospital clinicians and laboratory teams. Select the initial launch geography and assess the applicable regulatory pathway early.

    Milestone: A defined intended use and product profile.

  2. Establish Analytical Performance

    Optimize the assay and assess precision, detection limits, interference, sample stability, and reproducibility. Develop quality controls and a workflow suitable for the intended laboratory setting.

    Milestone: A reproducible assay ready for clinical evaluation.

  3. Demonstrate Clinical Value

    Plan prospective studies in the intended patient population. Evaluate performance, timing, and added value alongside existing assessments, including false-positive and false-negative results and their clinical implications.

    Milestone: Evidence supporting the intended diagnostic claims.

  4. Prepare for Market Access

    Pursue the regulatory requirements appropriate to the selected market and intended use. In parallel, establish manufacturing readiness, quality systems, supply, laboratory training, and the evidence needed for purchasing and reimbursement discussions.

    Milestone: Required authorization and operational readiness for launch.

  5. Launch in Selected Hospitals, Then Expand

    Following the required authorization, target a focused introduction in selected hospitals. Evaluate workflow performance, adoption, and clinical and economic value before broader rollout.

    Milestone: Evidence from initial implementation to guide expansion.

Regulatory route and timing depend on intended use and launch geography. Background on IVD development and U.S. regulation.

Proposed Initial Market Entry

Start Where Sepsis Decisions Are Made

A focused hospital entry strategy would connect the diagnostic to an existing clinical need and an established laboratory workflow.

Initial Care Setting

Prioritize hospital-based evaluation, with ICU and acute-care teams as potential early clinical collaborators. The first indication and eligible population will be defined through clinical and regulatory planning.

Adoption Partners

Seek clinical study sites and laboratory collaborators to refine sample handling, reporting, turnaround requirements, and training. Engage procurement and reimbursement stakeholders as evidence develops.

Evidence for Expansion

Assess whether the test adds actionable information, fits routine workflows, and delivers value for patients and hospitals. Expansion into additional settings or populations would require supporting evidence.

Intended Place in Clinical Practice

One Additional Signal in the Sepsis Assessment

The intended role is to add host-response information when clinicians assess possible sepsis. Clinical performance and the appropriate testing window remain development questions.

Clinical Assessment

Symptoms, vital signs, organ function, routine blood tests, and established biomarkers provide the clinical context for interpreting an iNOS result.

iNOS Host-Response Signal

The proposed assay measures a response of the patient to illness. Its intended contribution is additional information to support earlier sepsis recognition, subject to clinical validation.

Pathogen and Resistance Testing

Culture and molecular approaches such as PCR or sequencing address complementary questions about the infectious organism and, where supported, antimicrobial resistance. An iNOS result would not identify the organism or determine antibiotic susceptibility.

The diagnostic is intended to complement clinical judgment and existing testing. Its future use should fit urgent care pathways without delaying treatment. View the clinical integration workflow.

Future Research Opportunities

Build From the Sepsis Lead Program

The iNOS diagnostic remains the priority. Additional opportunities would be evaluated as evidence and resources permit:

  • Additional sepsis biomarkers: Explore whether complementary markers could improve assessment alongside iNOS.
  • Anti-iNOS monoclonal antibodies: A potential therapeutic research direction requiring separate preclinical, clinical, and regulatory development.
  • Broader applications: Longer-term possibilities include cardiovascular and neurological conditions, such as myocardial infarction differentiation and traumatic brain injury.
Discuss Clinical and Development Collaboration