Functional Fluidics Biomarkers assist Health Care Providers to improve outcomes by optimizing sickle cell patient monitoring and treatment.
Biomarkers As Clinical Monitoring Tool
There is an urgent need for validated biomarkers in sickle cell disease that facilitate open communication between the healthcare team and patients.
The clinical pain and fatigue characteristic of sickle cell disease is difficult to objectively quantify. Clinicians cannot depend on their physical exam, imaging studies, or laboratory data to validate claims of pain by their patients. This challenge often creates physician and patient dissatisfaction and makes it difficult to assess individual patient response to modifying therapy.
Functional Fluidics is a certified CLIA lab with biomarkers that may help objectively assess patient-reported outcomes (PROs) and response to disease modifying therapy.
Our Biomarkers for Red Blood Cell Health
Functional Fluidics proprietary biomarkers are unique diagnostic platforms that assess red blood cell health by replicating the environment that red blood cells experience in our bodies.
- 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.
Send Out Testing Services
Functional Fluidics biomarkers are available to Clinical Providers looking to improve the care of their sickle cell patients.
- Biomarkers:Our biomarkers objectively assess the impact of therapy on red blood cell health.
- Network:The send out process is simple and efficient with results available quickly.
- Expertise: Our experienced scientific and technical team can provide guidance as you consider how to best utilize our tests in a clinical environment
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.
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.
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.
Why Choose Functional Fluidics?
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Proprietary Lab Tests
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CLIA Certified Lab
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Complex Tests Experience
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Leadership Access
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Specialized Staff
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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)
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.
LEARN MORE 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.
Publications & Abstracts
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by Electronic Patient-Reported Outcomes, Actigraphy, and Biomarkers
This non interventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization.
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
We developed a standardized, flow-based adhesion assay to measure p-selectin mediated adhesion in SCD. Whole blood (Wb) and isolated WBC samples were perfused (1.0 dynes/cm2, 1.67Hz) through micro-fluidic channels
Sevuparin blocks sickle blood cell adhesion and sickleleucocyte rolling on immobilized L-selectin in a dose dependent manner
Adhesion of sickle red blood cells (SSRBC) to the vascular endothelium may initiate and propagate vascular obstruction in sickle cell disease (SCD)
Impact of Environment on Red Blood Cell ability to Withstand Mechanical Stress.
Susceptibility of red blood cells (RBC) to hemolysis under mechanical stress is represented by RBC mechanical fragility (MF), with different types or intensities of stress potentially emphasizing different perturbations of RBC membranes
An Approach to Measuring RBC Haemolysis and Profiling RBC Mechanical Fragility
Red blood cells (RBC) can be damaged by medical products, from storage or from disease. Haemolysis (cell rupture and haemoglobin release) is often a key indicator, with mechanical fragility (MF) offering the potential to assess sub-haemolytic damage as well
Low Molecular Weight Heparin Inhibits Sickle Erythrocyte Adhesion to VCAM-1 through VLA-4 Blockade in a Standardized Microfluidic Flow Adhesion Assay
The vaso-occlusive events in sickle cell disease (SCD) begin in early childhood, warranting the need for more preventative and therapeutic interventions for those affected
A Longitudinal Study to Identify and Assess Adhesion Indices during Vaso-Occlusive Crises in Adults and Adolescents with Sickle Cell Disease
Standardized adhesion indices may serve as useful biomarkers to asses the contribution of adhesin to an individual patient’s VOCs