Hemex Health Receives FDA Breakthrough Device Designation for Sickle Cell Disease Diagnostic Test
Key Insights
The FDA has granted Breakthrough Device Designation to Hemex Health (search)'s Gazelle® Hb Variant Test, recognizing its potential to address unmet needs in sickle cell disease (search) monitoring.
The Gazelle platform uses miniaturized electrophoresis technology to rapidly separate and detect hemoglobin fractions and variants, enabling decentralized access to quantitative hemoglobin data.
Through the Breakthrough Devices Program, Hemex will receive prioritized FDA interaction and feedback to expedite development of this point-of-care diagnostic solution.
Hemex Health (search) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Gazelle® Hb Variant Test, a diagnostic platform designed to improve monitoring and management of sickle cell disease (search) and other hemoglobinopathies (search). The designation recognizes the test's potential to address significant unmet medical needs in blood disorder diagnostics.
Breakthrough Device Program Benefits
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. Through this program, Hemex will receive prioritized interaction and feedback from the FDA as it advances development of the Gazelle Hb Variant Test (search).
"The Breakthrough Device Designation reflects the FDA's recognition of the need for improved tools to support the management of sickle cell disease (search)," said Patti White, CEO of Hemex Health (search). "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."
Technology Platform and Applications
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. Hemex is exploring the potential role of this technology in supporting therapeutic monitoring and disease management in sickle cell disease (search) and other hemoglobinopathies (search).
The company's diagnostic solutions are designed to be affordable for both low- and high-income areas and simple enough to be used by anyone, addressing the need for accessible point-of-care diagnostics in challenging healthcare environments.
Clinical Engagement and Research
Hemex recently presented multiple scientific posters and an oral presentation related to sickle cell disease (search) diagnostics and monitoring at the 66th American Society of Hematology (ASH) Annual Meeting, reflecting ongoing research and clinical engagement around hemoglobin variant testing.
Regulatory Status and Development
The Gazelle Hb Variant Test (search) 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, but provides a pathway for enhanced FDA engagement during the development process.
Gazelle technology was developed in collaboration with Case Western Reserve University. Hemex Health (search) operates from Portland, Oregon, U.S.A, and Mumbai and Coimbatore, India, focusing on developing affordable point-of-care diagnostics that deliver clinically actionable diagnostic solutions for blood-based conditions.