For decades, the pharmaceutical industry has faced challenges gaining approval for sickle cell disease therapies. The lack of consensus on objective primary endpoints is a major barrier to demonstrating the efficacy of these therapies in clinical trials and in clinical practice. Functional Fluidics is focused on addressing these barriers by validating diagnostic tools to define red blood cell health, and enable our partners to make red blood cell health an achievable target for sickle cell disease therapy.
Specialized Red Blood Cell Health Expertise
In Healthcare today, there is a tremendous need for well-validated biomarkers to objectively monitor red blood cell health. At Functional Fluidics our red blood cell function biomarkers support these evolving needs. Our suite of assays is currently offered nationally to clinical providers, pharmaceutical, academic and biotech partners to support drug development and patient care.
Functional Fluidics Red Blood Cell Health Biomarker CRO Services
Functional Fluidics has created and validated diagnostic tools to define red blood cell health, to enable our drug & therapy development partners to strive for healthy red blood cells as an acceptable and achievable target for sickle cell care. Our red blood cell health biomarker specialty CRO services include:
Our Services Are Tailored To Meet Your CRO Needs
Study Design & Protocol Development
Our expertise in RBC health translates into customized scientific and commercial strategies that advance the Sickle Cell Disease therapy product development pathway. Partnering with us means benefiting from our specialty focus and expertise:
- Sickle Cell Disease Therapy Focus: Our focus on Sickle Cell disease therapy means being at the leading edge of science and developing customized strategies that consider crucial scientific, regulatory, and commercial factors.
- Team Expertise: Our team has a wealth of diverse scientific knowledge from decades in both research and clinical settings to support across the spectrum – from early development to commercialization.
- Our Network: Our network of key opinion leaders including providers, researchers and patient advocacy groups means access to the best research resources as you navigate all phases of discovery, development, commercialization, and beyond.
Red Blood Cell Health Biomarker Technology
Our commercially available proprietary biomarker technology offers a pathway to scaling across all phases of clinical research - pre-clinical, clinical and post-marketing studies.
- Proprietary Biomarkers: Our biomarkers assess red blood cell health by replicating the environment that red blood cells experience in our bodies. By creating and validating diagnostic tools to define RBC health, we enable our pharma partners to strive for healthy red blood cells as an acceptable and achievable target for sickle cell disease care.
- Scales Across Continuum: Our biomarkers can be utilized across the continuum of drug development for Sickle Cell Disease and other red blood cell modifying therapies.
- Real World Data: Our biomarkers of RBC health are clinically available to healthcare providers for baseline monitoring, therapy start and monitoring and acute VOC. This allows our research partners to gain real world data on their modifying therapies for post marketing studies.
Central Laboratory Services
Functional Fluidics has an efficient CLIA laboratory that runs a suite of tests. In addition to our biomarkers of RBC health, we offer other RBC function assays (eg. Deformability, Osmocan, Oxygenscan) and standard hematological tests to provide a “one stop shop” for critical laboratory services.
- High Quality Data: Data from a central source with standardized results makes it easier for sponsors to assemble meaningful statistics and defend to regulatory agencies.
- Efficient Testing: Blood function assays are time-sensitive and running all assays in a common lab increases efficiency and reduces variability. This conserves blood volume, reduces need for sample shipping to multiple sites, reduces shipping-induced variability, and streamlines contracting.
- Sample Lifecycle Management: The sample life and the critical data it contains are supported at every step of the lifecycle management process — from kit production to sample destruction
Clinical Study Management
Our team supports sites and patients by overseeing the running of studies and directing strategy throughout the clinical trial process.
- Streamlined Site Operations: Our streamlined operations create time and cost efficiencies for increased productivity and enhanced performance while reducing burden on site staff.
- Patient Recruitment: Functional Fluidics supports patient access with their established network from working with Sickle Cell Disease patients and advocacy groups over the years.
- Patient-Centric Clinical Study Management: Our management enables engagement and retention with capabilities such as concierge services, home visits and electronic monitoring.
CRO Services Support Advancement of Sickle Cell Disease Therapy Development
Functional Fluidics provides red blood cell health biomarker CRO services to enable our partners to strive for healthy red blood cells as an acceptable and achievable target for sickle cell disease care.
Gene & Cell Therapy
As the gene therapy field strives to strike the balance between clinical efficacy and product safety in the context of mounting regulatory scrutiny. Our team can support the development of robust analytical tools to guarantee the consistency, quality and safety of gene therapy products.
There is a critical need to assess the normalization of red blood cell health in response to cell and gene therapy for sickle cell disease.
• Accelerated Study Timelines: Shortened time horizon for metrics to evaluate success of therapies- satisfying patient, provider and payer needs to see results.
• Performance Metrics: Assess gene editing performance targets in clinical trials.
• Outcomes: Predict clinically relevant red blood cell change outcomes in clinical trials and demonstrate progress metrics in a shorter time period.
• Patient Recruitment: Assess patient baseline to identify candidates most likely to respond successfully to therapy.
Management of Sickle Cell Disease is usually aimed at treating painful vaso-occlusive crises (VOCs), and managing detectable organ failure (cerebral vasculopathy, sickle nephropathy, priapism, acute chest syndrome, etc).
Functional Fluidics believes that treatment goals for individuals living with sickle cell disease should be to normalize the health of red blood cells and blood function in order to prevent clinical organ dysfunction
• Pharmacodynamic assessment: Assess the cellular-level response to candidate compounds / drugs in an in vitro context prior to gain more insight into mechanism of action and dose-response.
• Drug Monitoring: Evaluate the normalization of RBC health / blood function in response to RBC/SCD-modifying therapies or combination therapies over time.
• Patient Recruitment: Drive patient identification by stratifying patients with similar baseline metrics to help determine candidates most likely to benefit from and respond successfully to therapy.
• Standard of Care: Enable SCD or RBC-modifying therapies to be compared to standard of care or varying combinations of drugs.
CRO Services Support Clinical Research Across Continuum of Therapy Development
Functional Fluidics provides testing solutions to support our pharmaceutical partners across the continuum of drug development, with a specialized focus on red blood cell modifying therapies.
Pre-Clinical Validation Studies
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.
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.
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.
Functional Fluidics CLIA Laboratory Runs A Suite of Proprietary & Standard Lab Tests
Proprietary Red Blood Cell Tests
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. By creating and validating diagnostic tools to define RBC health, we enable our pharma partners to strive for healthy red blood cells as an acceptable and achievable target for sickle cell care.
Mechanical Fragility (MF)
Flow Adhesion of Whole Blood to VCAM-1 (FA-WB-VCAM)
Flow Adhesion of Whole Blood to P-selectin (FA-WB-Psel)
Flow Adhesion Characterization of WB to P-selectin (FAC-WB-Psel)*
Flow Adhesion Avidity of Whole Blood to VCAM (FAv-WB-VCAM)*
Flow Adhesion Avidity of Whole Blood to P-Selectin (FAv-WB-Psel)*
Flow Adhesion of Isolated WBC to P-selectin (FA-WBC-Psel)*
Flow Adhesion Characterization of WBC to P-selectin (FAC-WBC-Psel)*
*Research only red blood cell health assays
Other Lab Tests:
Along with our Functional Fluidics biomarkers of RBC health, we offer other RBC function assays like Deformability, Osmocan, Oxygenscan. We also offer standard hematological tests to provide a “one stop shop” for critical laboratory services.
For a complete list of our lab tests, click the "RBC Test Menu" button below.RBC Test Menu
Why Choose Functional Fluidics?
Proprietary Lab Tests
CLIA Certified Lab
Complex Tests Experience
Thought Leader Access
Strong Industry Relationships
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.
Red Blood Cell Mechanical Fragility as Potential Metric for Assessing Blood Damage Caused by Implantable Durable Ventricular Assist Devices: Comparison of Two Types of Centrifugal Flow Left Ventricular Assist Devices.
Implantable Ventricular Assist Devices (VADs) have become a treatment of choice for patients with end-stage heart failure or cardiogenic shock, significantly increasing both survival rates and the quality of life of patients.
Individual Variability in Response to a Single Sickling Event for Normal, Sickle Cell, and Sickle Trait Erythrocytes
Hemoglobin S (Hb-S) polymerization is the primary event in sickle cell disease causing irreversible damage to red blood cell (RBC) membranes over repeated polymerization cycles.
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
Impact of the Oscillating Bead Size and Shape on Induced Mechanical Stress on Red Blood Cells and Associated Hemolysis in Bead Milling
While in circulation, red blood cells (RBC) need to elastically undergo large deformations without lysing, an ability that may be compromised by cell membrane damage.