High Accuracy POC Test Identifies Genetic Blood Disorders

Genetic blood disorders known as beta-thalassemia and sickle cell disease (SCD) affect more than 7% of the global population and can result in severe complications, disability, or even death. SCD deaths can be prevented by early diagnosis, especially among African, Hispanic, Indian, Mediterranean, and Southeast Asian Americans, who are more likely to suffer from these disorders. SCD is thought to affect 100,000 people in the United States, with up to 8% of African-Americans being carriers. It can shorten a person’s life by up to 20 years. Now, a low-cost sickle cell and beta thalassemia test that is used in 27 countries aims to expand into the United States and replicate its international success.

The National Heart, Lung, and Blood Institute (NHLBI, Bethesda, MD, USA) have granted Hemex Health (Portland, Oregon, USA) a USD 3 million grant for three years to advance the commercialization of the company’s Gazelle Hb Variant Test for the U.S. market. Hemex intends to use the grant for FDA 510(k) clearance-related tasks. One of the tests supported by Hemex’s Gazelle diagnostic platform, the Hb Variant Test, can identify SCD and beta-thalassemia. Gazelle is a battery-powered, compact, and long-lasting machine that can be operated without the need for refrigeration by entry-level healthcare workers in areas with limited access, to resources, or electricity. Digitally stored data about the patient and the results are used later.

Incorporating miniaturized trusted technologies, innovative optics, and artificial intelligence, Gazelle is approved for use in the detection of SCD and beta-thalassemia in a growing number of nations. The business is able to serve a larger audience and expand its test menu to include additional diseases thanks to this adaptable design. Gazelle is a precise and quick digital platform that can be used in a variety of settings, including drive-through testing, border crossings, nursing homes, and other locations with limited resources.

Gazelle is a financially savvy and versatile place-of-care gadget that gives results comparable to standard lab tests without needing complex calculated help. Past examination has shown that it is profoundly exact, distinguishing SCD with close to 100% accuracy. The device and its cartridges are made to be affordable for underserved communities, and the results are shown on the screen in just 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.”