Effective drug development programs ideally begin exploring biomarker candidates at the preclinical phase.

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Pre-Clinical Validation Testing

Drugs that modify blood function (red blood cell health, thrombosis, WBC activation, etc.) often have corresponding clinical endpoints that are subjective and not easily evaluated in a clinical trial.

Even the best compounds evaluated in the most well-designed clinical trials can be derailed in the absence of biomarkers that can stratify the target population, monitor the effect of the drug, or serve as a surrogate endpoint.

At Functional Fluidics, we understand that effective drug development programs must begin exploring biomarker candidates at the preclinical phase.

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Animal or Observational Pre-Clinical study

Whether it is an animal study or an observational study on a target patient population, Functional Fluidics can:

  • Assess the efficacy of a drug based on functional markers of blood cell performance
  • Refine the mechanism of action of a drug based on in vitro blood function properties
  • Measure the pharmacodynamic response to red blood cell-modifying drugs as well as other blood function modifying drugs
  • Refine the dose and timing for optimal drug administration and maximum efficacy with minimal detrimental effects on blood cell function
  • Guide transition of a drug from in vitro, to animal, to human studies / clinical trials
  • Analyze the data from our extensive clinical data database to plan future studies for maximum impact
  • Stratify patient sample population and enrich your recruitment through functional biomarker-defined selection criteria

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Proprietary Lab Developed Tests

Whether your drug is in preclinical development or it already been approved by the FDA, healthcare providers will need well-validated biomarkers to objectively assess the impact on red blood cell health, and ultimately patient health. Our suite of proprietary cell function assays can help validate assumptions or support clinical claims.

  • Flow Adhesion:
    Our Flow Adhesion Assays capture the adhesive properties of an individual’s blood cells during conditions that simulate physiologic blood flow.
  • Mechanical Fragility :
    Our Membrane Fragility assay determines the stability of the intact RBC membrane, which indicates the health of the RBC and may predict RBC survival.

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Functional Fluidics Assays

Our suite of proprietary cell function assays can help validate assumptions or support clinical claims.

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    Flow Adhesion of whole blood on VCAM-1 (FA-WB-VCAM)
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    Flow Adhesion of whole blood on P-Selectin (FA-WB-Psel)
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    Mechanical Fragility – Normoxia (MF)
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Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS)

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Sickle cell disease (SCD) is characterized by frequent and unpredictable vaso-occlusive episodes (VOEs) that produce severe pain, organ damage, and early death. Lack of reliable biomarkers to objectively define VOEs, hinders the development of clinically useful interventions to improve the care for these patients.

Functional Fluidics recently participated in a ground-breaking study involving sickle cell patients. This non-interventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization.

The study data suggest that Functional Fluidics FA-WB-VCAM assay may serve as a predictive biomarker for impending VEEs, and a monitoring biomarker to assess response to SCD-modifying therapies.

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Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by Electronic Patient-Reported Outcomes, Actigraphy, and Biomarkers

Functional Fluidics Biomarker Assay Featured in ELIPSIS article in American Society of Hematology (ASH) Blood Magazine

Key Points

  • Feasibility of monitored out-of-hospital pain and patient-reported VOC days as endpoints for clinical trials in SCD is demonstrated.
  • ePROs, actigraphy, and laboratory biomarkers enable improved identification and assessment of in-hospital and out-of-hospital VOCs.
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Publications & Abstracts

Hemolytic Biomarkers Predict Adhesiveness of Sickle Blood Cells in a Clinical Adhesion Bioassay

The objective of this study was to identify hematologic lab values that contribute to cellular adhesion in our clinical adhesion bioassay.

Evaluation of Coagulation and Inflammatory Markers in Pediatric Patients on Extracorporeal Membrane Oxygenation (ECMO)

The aims of this study were to evaluate if novel laboratory tests could better predict patients at risk for bleeding and/or thrombosis compared to routine laboratory tests

Longitudinal Evaluation of a Standardized P-Selectin Flow Adhesion Bioassay: Potential Role for the Assessment and Prediction of Vaso-Occlusive Episodes in Sickle Cell Disease

Sevuparin blocks sickle blood cell adhesion and sickle-leucocyte rolling on immobilized L-selectin in a dosedependent manner

Impact of environment on Red Blood Cell ability to withstand mechanical stress

An approach to measuring RBC haemolysis and profiling RBC mechanical fragility

Low molecular weight heparin inhibits sickle erythrocyte adhesion to VCAM-1 through VLA-4 blockade in a standardized microfluidic flow adhesion assay

A Longitudinal Study to Identify and Assess Adhesion Indices during Vaso-Occlusive Crises in Adults and Adolescents with Sickle Cell Disease

 

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