Transforming Drug Development, Diagnostics & Patient Care
The case for ISF
ISF is rich in proteins, metabolites, nucleic acids, and other molecular signals. Many biomarkers found in blood are also present in ISF, but ISF has three advantages:
- Earlier detection: Local changes appear in ISF before spilling into systemic circulation.
- Cleaner signals: ISF is less influenced by diet, hydration, and acute systemic shifts that introduce noise into blood measurements.
- Patient-friendly access: New technologies enable low-burden, frequent sampling that supports decentralized and adaptive trials.
Current Standards of Care and Emerging Technologies
Today’s standards of care rely heavily on blood, tissue biopsies, urine, stool, and cerebrospinal fluid to provide molecular insights. While these fluids have driven enormous progress, they share common shortcomings: they can miss early disease signals, they often produce noisy or nonspecific results, and the methods for collecting them can be invasive or inconvenient. At the same time, emerging technologies such as multi-cancer blood tests and wearable biosensors are beginning to address these gaps. ISF offers a powerful complement: it captures local and systemic signals, can be sampled frequently with minimal burden, and enables more actionable insights across the care continuum.
|
THERAPEUTIC AREA
|
TODAY
|
EMERGING
|
ISF OPPORTUNITY
|
|---|---|---|---|
|
Diabetes & Metabolic Care
|
Fingersticks, HbA1c, CGM, TIR.
|
Multi-analyte metabolic tracking beyond glucose.
|
CGM validated ISF as a scalable fluid. Expanding to additional analytes/biomarkers(ketones, lipids) could transform metabolic health management.
|
|
Cardiology
|
Blood troponin for MI, BNP/NT-proBNP for heart failure.
|
Point-of-care and remote monitoring solutions.
|
Near-real-time tracking of cardiac markers could accelerate triage and enable proactive management outside of the hospital.
|
|
Oncology
|
Tissue biopsy, blood-based tumor markers, and circulating tumor DNA (ctDNA).
|
Multi-cancer early detection (MCED) blood tests, minimal residual disease(MRD) monitoring.
|
|
|
Immunology & Inflammation
|
Blood-based CRP, ESR, and cytokine panels.
|
Cytokine profiling for trial stratification and toxicity monitoring.
|
ISF reflects local immune activity, enabling more sensitive, specific, and timely detection of inflammatory states.
|
|
Neurology
|
Serum NfL for multiple sclerosis and neurodegenerative disease, CSF analysis for Alzheimer’s.
|
Serum biomarker panels for early neurodegeneration.
|
Longitudinal ISF sampling can support patient-friendly monitoring of neurological disease activity and therapeutic impact, without the invasiveness of lumbar puncture.
|
|
Dermatology & Wound Care
|
Visual assessments and occasional biopsies.
|
Local biomarker monitoring to guide therapy.
|
ISF directly reflects local cytokines and metabolites, enabling molecular monitoring of wound healing, psoriasis, and other skin conditions.
|
|
Therapeutic Drug Monitoring
|
Plasma troughs and exposure estimates.
|
Emerging: Model
|
ISF reflects unbound, tissue-level drug concentrations, providing a more accurate picture of pharmacodynamics at the site of action.
|
Strategic Implications for Pharma & Diagnostics
The adoption of ISF as a mainstream biofluid carries implications that reach far beyond a new testing modality. It has the potential to reshape how pharma designs and executes clinical programs, how diagnostics companies think about early detection, and how patients engage with long-term monitoring. By enabling earlier insights, cleaner data, and more patient-friendly sampling, ISF offers a platform that cuts across the full drug and diagnostic lifecycle.
Drug Development
- Reduce attrition with earlier biomarker-based go/no-go decisions.
- Improve translational success by aligning preclinical and clinical data in the same fluid.
Clinical Trials
- Enable decentralized, adaptive designs with high-frequency, minimally invasive sampling.
- Boost patient recruitment and retention by reducing burden compared to blood draws.
Diagnostics & Monitoring
- Expand multi-analyte panels that cover oncology, cardiology, neurology, and beyond.
- Improve compliance and broaden adoption with less invasive collection methods.
Post-Market Surveillance
- Support real-world pharmacovigilance with ongoing ISF monitoring.
- Detect adverse events earlier and provide stronger evidence for label expansions.
Conclusion
ISF is poised to become the next frontier in molecular diagnostics and drug development. Just as continuous glucose monitoring transformed diabetes care, ISF-based biomarker platforms have the potential to redefine how diseases are detected, drugs are developed, and patients are monitored. With the right investment and partnerships, pharma, life sciences, and diagnostics companies can harness ISF to unlock earlier insights, reduce trial failures, and create new categories of patient-friendly diagnostics.
