Hemex Health's Gazelle® Test Earns FDA Breakthrough Status for Sickle Cell Diagnostics
Hemex Health's Gazelle® Test Earns FDA Breakthrough Status for Sickle Cell Diagnostics
Hemex Health's Gazelle® Test Earns FDA Breakthrough Status for Sickle Cell Diagnostics
Hemex Health has secured a key regulatory milestone for its Gazelle® Hb Variant Test. The U.S. Food and Drug Administration (FDA) granted the device Breakthrough Device Designation, a move aimed at speeding up its development. This follows recent scientific presentations at a major haematology conference, where the company showcased its progress in sickle cell disease diagnostics.
The test, still under review, is not yet available for sale in the U.S. but represents a step forward in decentralised blood testing for challenging markets.
The Breakthrough Device Designation allows Hemex Health to work more closely with the FDA. Through this programme, the company will receive faster feedback and prioritised support as it develops the Gazelle® Hb Variant Test. The FDA's initiative targets devices that address life-threatening or severely debilitating conditions, such as sickle cell disease.
Hemex Health recently highlighted its technology at the 66th American Society of Hematology (ASH) Annual Meeting. There, researchers presented multiple scientific posters and an oral session focused on improving diagnostics for sickle cell disease. The Gazelle® platform itself relies on miniaturised electrophoresis to quickly separate and identify hemoglobin variants.
Originally developed with Case Western Reserve University, the Gazelle® technology is now being explored beyond diagnostics. Hemex Health is investigating its potential for monitoring treatments and managing hemoglobinopathies over time.
Regulatory progress has accelerated since the 2023 ASH conference. In October 2024, the FDA approved the test for diagnosing sickle cell disease and related variants. Clinical studies, including the completed GLOW trial in 2025, confirmed its effectiveness across diverse populations. Meanwhile, the company has begun the process for CE certification in Europe, aiming for approval by early 2026.
The Breakthrough Device Designation brings Hemex Health one step closer to U.S. approval for its Gazelle® Hb Variant Test. If cleared, the technology could improve sickle cell disease management through faster, decentralised testing. The company continues to advance clinical and regulatory efforts in both the U.S. and Europe.