Functional Fluidics' Red Blood Cell Biomarkers May Prove to be Effective Surrogate Endpoints for Sickle Cell Disease Severity

DETROIT, Feb. 21, 2022 /PRNewswire/ — Functional Fluidics ( officially announced the publication of its two-year study, demonstrating that its red blood cell (RBC) health biomarkers can identify individuals with sickle cell disease at greatest risk for more severe outcomes. Further research is needed to determine the clinical value of stratifying patients according to these RBC health biomarkers. Assessing RBC health could help healthcare providers identify patients at risk for severe disease outcomes so that they can intervene earlier. Functional Fluidics is a diagnostics company striving to be the gold standard for red blood cell health.

"In the absence of blood-based surrogate endpoints, people living with sickle cell disease have had to suffer excruciating pain crises and organ damage to alert healthcare providers that they are in need of treatment," said Patrick Hines, CEO and Founder of Functional Fluidics. "Our latest research indicates that one of our clinically available red blood cell health tests called Flow Adhesion of Whole Blood to VCAM (FA-WB-VCAM) may be a plausible surrogate endpoint for SCD severity. The bottom line is this: we have the tools to keep red blood cells healthy so people with sickle cell disease don’t have to suffer. I am proud of the work that my team at Functional Fluidics and countless researchers and healthcare providers around the world are doing to keep our sickle cell warriors healthy."

Functional Fluidics Biomarkers: Improving how Sickle Cell Disease is monitored and treated

The objective of this study was to assess the clinical predictive value of red blood cell adhesion or "stickiness" in individuals with sickle cell disease using a Functional Fluidics biomarker called the Flow Adhesion of Whole Blood to Vascular Cell Adhesion Molecule (FA-WB-VCAM). The analysis was conducted on participants in the ELIPSIS study, which was a six-month, longitudinal, observational study of individuals with sickle cell disease during at-home, steady-state and self-reported pain events, and following pain event resolution. Important takeaways from the study:

  • There are no validated blood-based surrogates for sickle cell disease severity.
  • Individuals with sickle cell disease on stable hydroxyurea therapy have less RBC "stickiness" (FA-WB-VCAM) compared to those not on hydroxyurea. There was no significant difference in VCAM adhesion between subjects at steady state and during VOC. A subanalysis however showed significantly higher VCAM adhesion and VOCs at home vs contact (ER or hospital) or at steady state.
  • These data suggest that RBC stickiness measured with FA-WB-VCAM during self-reported steady state can stratify individuals with SCD into high and low risk categories based on their prospective risk of worse SCD severity (vaso-occlusive end organ event frequency).
  • RBC stickiness measured with the FA-WB-VCAM test may prove to be an effective surrogate endpoint for SCD severity. Monitoring RBC health could help healthcare providers proactively direct appropriate therapies to individuals with SCD at greatest risk for severe disease outcomes, changing the existing care model from crisis intervention to health maintenance.

For the latest research findings, upcoming webinars or events, and information on RBC health and SCD treatment, follow Functional Fluidics on social media: Facebook, Twitter, Instagram, LinkedIn, YouTube.

About Functional Fluidics

Functional Fluidics is a biotechnology company with a high complexity CLIA-certified diagnostic lab striving to be the gold standard in red blood cell (RBC) health: beginning with Sickle Cell Disease. Functional Fluidics provides RBC function biomarkers to address an evolving healthcare need for well-validated biomarkers that objectively monitor RBC health. They offer a suite of assays to clinical providers, pharmaceutical, academic, and biotech partners across the United States to help support new drug development and overall patient care. Functional Fluidics also offers Specialty Contract Research and Send Out Test Services across the U.S. Learn more at:

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SOURCE Functional Fluidics