POC Test Detects Genetic Blood Disorders with High Accuracy

Sickle cell disease (SCD) and beta thalassemia are genetic blood disorders that affect over 7% of the global population, posing the risk of severe complications, disability, and even death. Early diagnosis is crucial and can prevent thousands of SCD-related deaths, especially among Americans of African, Hispanic, Indian, Mediterranean, and Southeast Asian descent, who are more susceptible to these disorders. In the US, SCD is estimated to affect 100,000 people, with up to 8% of African-Americans being carriers, and can reduce life expectancy by up to 20 years. Now, an affordable sickle cell and beta thalassemia test that is currently used in 27 countries seeks to replicate its international success and expand into the U.S.

Hemex Health (Portland, Oregon, USA) has been awarded a three-year, USD 3 million grant from the National Heart, Lung, and Blood Institute (NHLBI, Bethesda, MD, USA) to advance the commercialization of the company’s Gazelle Hb Variant Test for the U.S. market. Hemex intends to use the grant to complete activities required for FDA 510(k) clearance. The Hb Variant Test, one of the tests supported by Hemex’s Gazelle diagnostic platform, can detect SCD and beta thalassemia. Gazelle is a compact, durable, battery-powered, and can be operated at a low cost by entry-level healthcare workers in areas with limited access, resources, or electricity, without the need for refrigeration. Results and patient information are digitally captured for later use.

Image: The Gazelle Hb Variant test identifies hemoglobin disorders rapidly, easily, and inexpensively (Photo courtesy of Hemex Health)

Gazelle is authorized in a growing number of countries for the detection of SCD and beta thalassemia and incorporates miniaturized trusted technologies, innovative optics, and artificial intelligence. This versatile design enables the company to expand its test menu to include other diseases and to serve a broader user base. Gazelle is an accurate and rapid digital platform that can function in various settings, from remote, low-resource locations to drive-through testing, border crossings, or nursing homes.

Gazelle is a cost-effective and portable point-of-care device that provides results equivalent to standard lab tests without requiring complex logistical support. Previous research has shown that it is highly accurate, detecting SCD with 99% precision. The device and cartridges are designed to be affordable for underserved communities, and results are displayed on the screen in only eight minutes.

"An accurate point-of-care test for sickle cell disease and trait is crucial in helping address the challenges of misdiagnosis and undiagnosed patients who could potentially miss out on life saving medical care,” said Dr. Stephen Boateng, Director of Research, Sickle Cell 101, a non-profit patient group providing sickle cell education to individuals impacted by the condition in the U.S. and globally. “Such a test that can also provide results in minutes provides an additional benefit, especially during community outreach events where participants could be lost to follow up due to the length of time it might take for results to come back."

“Millions of Americans are carriers of the sickle cell trait or beta thalassemia trait, but according to research, only a small percentage know their status,” said Patti White, CEO, Hemex Health. “This test can empower people to quickly learn their status, which may impact family planning or other important decisions.”

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