Hemex's Gazelle Test Earns FDA Breakthrough Status for Sickle Cell Diagnosis
Hemex's Gazelle Test Earns FDA Breakthrough Status for Sickle Cell Diagnosis
Hemex's Gazelle Test Earns FDA Breakthrough Status for Sickle Cell Diagnosis
Hemex Health has secured a key regulatory milestone for its sickle cell disease diagnostic tool. The company's Gazelle® Hb Variant Test received FDA Breakthrough Device Designation on 6 February 2026. This move aims to speed up development for a condition with urgent diagnostic needs.
The FDA's Breakthrough Device Designation programme helps accelerate the review of technologies targeting life-threatening or debilitating illnesses. With this status, Hemex will now receive faster feedback and prioritised support from the agency as it prepares for an upcoming U.S. submission. The test itself, however, remains unapproved and unavailable for sale in the United States.
The Gazelle platform relies on miniaturised electrophoresis to separate and detect hemoglobin variants. Hemex has already showcased related research at the 66th American Society of Hematology (ASH) Annual Meeting. Beyond diagnostics, the company is also exploring applications for monitoring sickle cell disease and other hemoglobinopathies.
The designation marks a step toward addressing gaps in sickle cell disease management. Hemex will continue working with the FDA to refine the Gazelle Hb Variant Test. Until approval, the device cannot be marketed or sold in the U.S.