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 Hb Variant Test, one of the tests supported by the Gazelle diagnostic platform, 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, and 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 highly accurate testing to low resource populations who have never had access to this level of testing.
With this grant, Hemex seeks to replicate its international success and expand into the United States.
The CDC states that genetic blood disorders are most prevalent among Americans of African, Hispanic, Indian, Mediterranean, and Southeast Asian descent. The American Society of Hematology (ASH) estimates that 100,000 Americans have SCD and that up to three million are carriers, including up to 8% of African-Americans. In the US, the CDC says that SCD can decrease life expectancy by up to 20 years.
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. This test can empower people to quickly learn their status, which may impact family planning or other important decisions."
Patti White, CEO, Hemex Health
"As we have done around the world, Hemex hopes to use our products to bring the needs of sickle cell and beta thalassemia patients into the light of day by reaching the hard-to-reach, and providing this population with the diagnoses they need to get effective treatment," said Ms. White. "I am incredibly proud of our team and our products, and grateful to NHLBI for the opportunity they have given us to bring our work to the US."
This work is funded by the National Heart, Lung, and Blood Institute under grant award number 2R44HL140739-04. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.