FDA awards breakthrough device status to sickle cell diagnostic test
Hemex Health's platform offers faster, lower-cost alternative to lab testing
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The Food and Drug Administration (FDA) has granted breakthrough device designation to the Gazelle Hb Variant test, a point-of-care blood test developed by Hemex Health to enable rapid, low-cost diagnosis of sickle cell disease (SCD) and beta thalassemia.
The designation is meant to accelerate the development and review of medical technologies that could improve the diagnosis or treatment of serious or life-threatening conditions. With this designation, Hemex will receive prioritized feedback and closer communication with the FDA as the company advances the test’s development.
“The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease,” Patti White, Hemex’s CEO, said in a company press release. “We appreciate the opportunity for early and frequent engagement with the agency as we continue to develop diagnostic technologies intended to deliver clinically meaningful information closer to patients.”
The Gazelle Hb Variant test is already commercially available in more than 40 countries, including locations across Africa, India, the Middle East, and Southeast Asia.
Diagnosing SCD usually requires sending blood samples to lab
Both SCD and beta thalassemia are caused by genetic mutations that affect the production of hemoglobin — the protein that carries oxygen in red blood cells. In SCD, an abnormal form of hemoglobin is produced, leading to misshapen red blood cells that can block blood flow. In beta thalassemia, the body produces too little hemoglobin, leading to anemia.
Diagnosing these conditions usually requires collecting blood samples at a doctor’s office and sending them to a specialized lab for analysis. There, a technique called electrophoresis is used to separate and identify different versions of hemoglobin based on how they move in an electric field, which depends on their size and electrical charge.
The Gazelle Hb Variant test is designed as a smaller, automated version of this approach that requires minimal expertise and can be performed in routine care settings. It runs on Hemex’s portable, easy-to-use Gazelle device and uses a disposable cartridge to analyze a small blood sample that’s typically collected from a finger prick.
The test has shown 99% accuracy compared with standard diagnostic tests, meaning it performs just as well at diagnosing SCD. But unlike traditional testing — which can take days because samples must be sent to specialized labs — the device can deliver results in as little as eight minutes. This means people could potentially be tested and receive their results during the same visit.
By offering a faster, more affordable alternative to conventional lab testing, Hemex aims to expand access to SCD testing in both low- and high-income areas. This is particularly important in underserved communities that lack specialized lab infrastructure and have historically had limited access to this type of testing.
The company is also exploring the potential use of the Gazelle platform beyond diagnosis to support therapeutic monitoring and disease management in people with SCD and other hemoglobin disorders.
