FDA awards breakthrough device status to sickle cell diagnostic test

The Food and Drug Administration (FDA) has granted breakthrough device designation to the Gazelle Hb Variant test, a point-of-care blood test developed by Hemex Healthexternal link, opens in a new tab to enable rapid, low-cost diagnosis of sickle cell diseaseexternal link, opens in a new tab (SCD) and beta thalassemia.

The designation is meant to accelerate the development and review of medical technologies that could improve the diagnosis or treatment of serious or life-threatening conditions. With this designation, Hemex will receive prioritized feedback and closer communication with the FDA as the company advances the test’s development.

“The Breakthrough Device Designation reflects the FDA’s recognition of the need for improved tools to support the management of sickle cell disease,” Patti White, Hemex’s CEO, said in a company press releaseexternal link, opens in a new tab. “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 Gazelle Hb Variant test is already commercially availableexternal link, opens in a new tab in more than 40 countries, including locations across Africa, India, the Middle East, and Southeast Asia.