The test uses miniaturized electrophoresis technology designed to enable decentralized access to quantitative hemoglobin data.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Hemex Health’s Gazelle Hb Variant Test, a diagnostic platform designed to rapidly separate and detect hemoglobin fractions and variants using miniaturized electrophoresis technology.
The Portland, Oregon-based medical diagnostics company announced the designation, which is intended to expedite 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 the program, Hemex will receive prioritized interaction and feedback from the FDA as it advances development of the Gazelle Hb Variant Test for potential use in supporting therapeutic monitoring and disease management in sickle cell disease and other hemoglobinopathies.
“The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease,” says Patti White, CEO of Hemex Health, in a 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.”
Platform Designed for Decentralized Testing
The Gazelle platform aims to enable decentralized access to quantitative hemoglobin data through its miniaturized electrophoresis approach. Hemex is exploring the technology’s potential role in supporting therapeutic monitoring and disease management for patients with sickle cell disease and other hemoglobinopathies.
The company recently presented multiple scientific posters and an oral presentation related to sickle cell disease diagnostics and monitoring at the 66th American Society of Hematology Annual Meeting, reflecting ongoing research and clinical engagement around hemoglobin variant testing.
Hemex Health focuses on developing point-of-care diagnostics for blood-based conditions in challenging markets. 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, according to the company.
Regulatory Status
The Gazelle Hb Variant Test has not been cleared or approved by the FDA and is not available for sale in the US. Breakthrough Device Designation does not guarantee regulatory clearance.
Gazelle technology was developed in collaboration with Case Western Reserve University. Hemex Health operates locations in Portland, Oregon, and Mumbai and Coimbatore, India.
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