Rapid Cartridge-Based Test Aims to Expand Access to Hemoglobin Disorder Diagnosis

Conventional workflows typically depend on techniques that separate hemoglobin variants to confirm disease status, which can take days and demand trained personnel. A new point-of-care test has now received Breakthrough Device designation from the Food and Drug Administration (FDA), recognizing its potential to deliver rapid, lower-cost results closer to patients.

Hemex Health’s (Portland, OR, USA) Gazelle Hb Variant test is a point-of-care blood test designed to enable rapid diagnosis of sickle cell disease and beta thalassemia. The technology automates the core principles of electrophoresis within a compact, user-friendly format. Operating on the portable Gazelle device, it uses a disposable cartridge to analyze a small blood sample, typically obtained via finger prick. By miniaturizing and streamlining the workflow, the system is designed to deliver reliable results with minimal training or technical expertise.

In comparative assessments with standard diagnostic methods, the assay has demonstrated 99% accuracy and can deliver results in as little as eight minutes. By eliminating shipping to specialized laboratories and associated delays, the platform is positioned as a faster, lower-cost alternative that can enable same‑visit reporting of results. The Gazelle Hb Variant test is already commercially available in more than 40 countries across Africa, India, the Middle East, and Southeast Asia.

The company is evaluating the Gazelle platform not only for initial diagnosis but also for therapeutic monitoring and long-term disease management in hemoglobin disorders. Designed as a portable, cartridge-based system, the technology aims to expand access to testing in regions that lack specialized laboratory infrastructure. The FDA’s Breakthrough Device Program recognizes technologies with the potential to improve the diagnosis or treatment of serious or life-threatening conditions and is intended to expedite regulatory interactions as development advances.

“The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease,” said Patti White, CEO of Hemex Health. “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.”

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