Breakthrough Device Designation Awarded to Hemex Health for Gazelle Hb Variant Test

Hemex Health has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Gazelle Hb Variant Test.

“The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease,” Hemex Health CEO Patti White said. “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 FDA’s Breakthrough Devices Program aims to expedite the development, assessment, and review of medical devices that potentially can 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 develops the Gazelle Hb Variant Test.

The Gazelle platform is designed to rapidly separate and detect hemoglobin fractions and variants using miniaturized electrophoresis technology, to enable decentralized access to quantitative hemoglobin data. Hemex is exploring the technology’s potential role in supporting therapeutic monitoring and disease management in sickle cell disease and other hemoglobinopathies.

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.

Hemex Health impacts health outcomes in the world’s most challenging markets by developing affordable point-of-care diagnostics that quickly deliver clinically actionable diagnostic solutions for blood-based conditions. The company’s diagnostic solutions are affordable for both low- and high-income areas and simple enough to be used by anyone. Gazelle technology was developed in collaboration with Case Western Reserve University. Hemex Health maintains operations in Portland, Ore., and Mumbai and Coimbatore, India.