Researchers from Case Western Reserve University presented research Saturday in which Hemex Health’s Gazelle platform diagnostic technology successfully tested 46 patients with 100% sensitivity and over 92.3% specificity for anemia and with 100% accuracy for hemoglobin variants. The preliminary study included blood samples collected from Cleveland-area patients studied for anemia and sickle cell disease.
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Gazelle is a compact, rugged, battery-operated diagnostic device. Gazelle can be used inexpensively, with no cold chain requirements by entry level healthcare workers in areas with limited access, resources or electricity. Patient information and results are captured digitally for storage, printing, or later transmission to the cloud. Researchers are developing software upgrades that may enable the device to detect additional diseases. (Photo: Business Wire)
The combined, single test for anemia and sickle cell disease is thought to be a first and should provide a vital new tool for disease detection and management in low resource settings where incidents of sickle cell disease are high and often go undiagnosed. This test is expected to be available in mid-2021 after regulatory permission in identified countries.
“Health practitioners with whom we spoke in Africa and Asia told us that one of the greatest obstacles to better diagnosis and management for anemia and sickle cell disease is the lack of an affordable, easy to use test that can provide regular data to help optimize treatment,” said Patti White, co-founder and CEO, Hemex Health. “The study from Case Western Reserve demonstrates that a software enhancement to our Gazelle platform holds the potential to allow our current sickle cell disease test to also check for anemia, which could help clinicians and patients to optimize disease management through a single, low cost test.”
The research team compared the study samples to the current clinical standard detection of anemia (complete blood count [CBC]) and sickle cell disease (High-Performance Liquid Chromatography [HPLC]).
“With an integrated total hemoglobin and hemoglobin variant test, clinicians can help patients better understand their condition, because iron deficiencies and nutrition issues can cause anemia without a patient having sickle cell disease,” said Umut Gurkan, PhD, Associate Professor, Case Western Reserve University, lead researcher of the team that presented the findings at the 62nd American Society of Hematology Annual Meeting. “Gazelle reminds me of Tesla because the technology transforms with a software upgrade, and that’s all it takes to add the hemoglobin test to the existing platform.”
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