Gazelle Hb Variant Test
Sickle Cell Disease, Beta Thalassemia
Commercial (ex-US); FDA Breakthrough Designation (US)Active
Key Facts
Indication
Sickle Cell Disease, Beta Thalassemia
Phase
Commercial (ex-US); FDA Breakthrough Designation (US)
Status
Active
Company
About Hemex Health
Hemex Health is a private, commercial-stage diagnostics company with its Gazelle platform already deployed in over 40 countries, though not yet cleared for sale in the United States. The portable, battery-powered platform integrates microchip electrophoresis and fluorescent immunoassay (FIA) technologies to provide quantitative results for hemoglobin variants and ferritin levels in minutes. The company recently received FDA Breakthrough Device Designation for its Hb Variant Test, signaling significant regulatory progress and potential for U.S. market entry. Its core mission is to address the vast unmet need for accessible, point-of-care testing for inherited blood disorders and anemia worldwide.
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