January 2023: Clinical Study with Sickle Cell Disease patients in Ghana demonstrates the clinical utility of novel screening technology for kidney disease
After more than two years and one major pandemic, the results are in: Our clinical study confirmed that our technique identifies smaller urinary proteins, thus allowing a clinician to watch for signs of kidney damage and possibly start earlier intervention. These results may have a significant impact on helping people with sickle cell disease live longer and more productive lives. This research is a collaboration of prestigious global organizations to identify urinary biomarkers that can be used to diagnose the early onset of kidney disease in Sickle Cell Disease (SCD) patients.
A special thanks to the clinical study team of Elijah Paintsil, MD, from Yale School of Medicine who provided key inputs into the trial design, Margaret Lartey, MD, Former Dean of the University of Ghana Medical School, Vincent Boima, MD, principal investigator at University of Ghana, Yvonne Dei-Adomakoh, MD, the entire team at the University of Ghana, our laboratory partner Green Mountain Antibodies, Don Very, PHD, Head of Science at ILSC, and Markus Warlitz, Head of Operations at ILSC, without whose care and diligence the trial would never have been completed.
Clinical study design and outcome
Consistent with ILSC’s mission of making a measurable global impact on non-communicable diseases through therapeutics, diagnostics, research, and education, we seek to address this unmet diagnostic need in African patients with SCD. We evaluated the clinical utility of our urinary protein immunoassay in a proof-of-concept study involving 150 patients in Ghana (50 non-disease, 50 SCD patients without proteinuria, and 50 SCD patients with proteinuria). After the collection was completed, urine samples were sent to Green Mountain Antibodies in Burlington, VT, for analysis using our protein immunoassay and demonstrating its clinical utility.