Hemex Health Receives FDA Breakthrough Device Designation for Gazelle® Hb Variant Test

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Hemex Health, a medical diagnostics company focused on decentralized testing for blood-based conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Gazelle® Hb Variant Test. The Gazelle platform is designed to rapidly separate and detect hemoglobin fractions and variants using miniaturized electrophoresis technology, with the goal of enabling decentralized access to quantitative hemoglobin data.

Why it matters

The FDA's Breakthrough Devices Program is intended to expedite the development, assessment, and review of medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases like sickle cell disease. This designation reflects the FDA's recognition of the need for improved tools to support the management of sickle cell disease.

The details

Through the Breakthrough Devices Program, Hemex will receive prioritized interaction and feedback from the FDA as it advances development of the Gazelle Hb Variant Test. Hemex is exploring the potential role of this technology in supporting therapeutic monitoring and disease management in sickle cell disease and other hemoglobinopathies.

• Hemex recently presented multiple scientific posters and an oral presentation related to sickle cell disease diagnostics and monitoring at the 66th American Society of Hematology (ASH) Annual Meeting.

What they’re saying

What’s next

The Gazelle Hb Variant Test has not been cleared or approved by the FDA and is not available for sale in the United States. Breakthrough Device Designation does not guarantee regulatory clearance.