Hemex Health Awarded $3M NIH Grant to Bring Gazelle Hb Variant Test for Sickle Cell Disease to US Market
PORTLAND, Ore., March 27, 2023 (GLOBE NEWSWIRE) -- Hemex Health, a medical diagnostic device company focused on expanding healthcare access to underrepresented patient populations, announced it has been awarded a 3-year, $3 million grant from the National Heart, Lung, and Blood Institute (NHLBI). NHLBI, part of the National Institutes of Health, awarded a SBIR Phase IIB Bridge Award to Hemex to advance the commercialization of the company’s Gazelle® Hb Variant Test for the United States market.
Hemex intends to use the grant to complete activities required for FDA 510(k) clearance.
The Gazelle Hb Variant Test can detect Sickle Cell Disease (SCD) and beta thalassemia – genetic blood disorders that can result in debilitating pain, disability, severe complications or death.
As an affordable, portable, point-of-care test, Gazelle’s results are equivalent to standard lab tests but do not require complex logistical support. Gazelle is highly accurate: previous research found that it can detect SCD with 99% accuracy. The device and cartridges are designed to be affordable for underrepresented communities. Test results appear onscreen 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."
Armed with these advantages, Gazelle is helping to revolutionize the diagnosis of these disorders, having conducted hundreds of thousands of tests in 27 countries across India, Africa, the Middle East, and Southeast Asia. Gazelle is bringing accurate testing to populations who have never had access to this level of testing.
With this grant, Hemex seeks to expand into the United States.
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