Functional Fluidics supports pharmaceutical and academic partners in evaluation, development and bringing new therapies to market.

Specialized Testing Expertise

Functional Fluidics specializes in assessing blood function, with a specific focus on red blood cell health. Our proprietary testing platforms assess key properties underpinning RBC function and survival.

While well-positioned to address the needs of clients with large-scale validation studies, we also provide insights into the individual patient-level response critical for development of personalized medical applications. Our CLIA-certified lab is available for both high-throughput cell function testing, and to assaying unique patient samples, where you may be asking the questions related to drug safety of mechanisms of action.

 

 
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Our Biomarkers for Red Blood Cell Health

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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Contract Research Services

Functional Fluidics provides testing solutions to support our pharmaceutical and academic research partners across the continuum of drug development, with a specialized focus on red blood cell modifying therapies.

  1. Biomarkers:Our biomarkers objectively assess the impact of a drug on red blood cell health and survival, thus reducing scientific and regulatory risks.
  2. Network:Our strong network of healthcare providers allows Functional Fluidics to facilitate clinical studies/trials for our pharma partners.
  3. Expertise: Our experienced scientific and technical team can assist in developing a successful research strategy.
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Pre-Clinical Validation Studies

Functional Fluidics biomarkers can determine the effects of your therapy on red blood cell function and assess dose-dependent pharmacodynamic effects in an in vitro context. Blood samples from both human and animal models (including mice) can be used.

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Clinical Studies

Functional Fluidics biomarkers can determine the effects of your experimental therapy on red blood cell function and assess dose-dependent pharmacodynamic effects in the context of clinical trials by assessing blood samples from study subjects treated with your therapy.

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Post-Marketing Studies

Functional Fluidics biomarkers can determine the effects of your FDA-approved therapy on red blood cell function and assess a proposed mechanism of action or identify optimal dosages in the context of a post-marketing study.

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Why Choose Functional Fluidics?

  • New Project

    Proprietary Lab Tests

  • New Project(1)

    CLIA Certified Lab

  • New Project(5)

    Complex Tests Experience

  • New Project(2)

    Leadership Access

  • New Project(3)

    Specialized Staff

  • New Project(4)

    Strong Industry Relationships



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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