Hemex Health, a medical diagnostic gadget firm centered on increasing healthcare entry to underrepresented affected person populations, introduced it has been awarded a 3-year, $3 million grant from the National Heart, Lung, and Blood Institute (NHLBI). NHLBI, a part of the National Institutes of Health, awarded a SBIR Phase IIB Bridge Award to Hemex to advance the commercialization of the corporate’s Gazelle^® Hb Variant Test for the United States market.

Hemex intends to make use of the grant to finish actions required for FDA 510(okay) clearance.

The Hb Variant Test, one of many checks supported by the Gazelle diagnostic platform, can detect Sickle Cell Disease (SCD) and beta thalassemia – genetic blood problems that may end up in debilitating ache, incapacity, extreme issues or loss of life.

As an inexpensive, transportable, point-of-care take a look at, Gazelle’s outcomes are equal to plain lab checks however don’t require advanced logistical assist. Gazelle is very correct: earlier analysis discovered that it could actually detect SCD with 99% accuracy. The gadget and cartridges are designed to be inexpensive for underrepresented communities, and take a look at outcomes seem onscreen in solely 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,” stated Dr. Stephen Boateng, Director of Research, Sickle Cell 101, a non-profit affected person group offering sickle cell training to people impacted by the situation within 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 benefits, Gazelle helps to revolutionize the prognosis of those problems, having carried out lots of of hundreds of checks in 27 nations throughout India, Africa, the Middle East, and Southeast Asia. Gazelle is bringing extremely correct testing to low useful resource populations who’ve by no means had entry to this degree of testing.

With this grant, Hemex seeks to copy its worldwide success and increase into the United States.

The CDC states that genetic blood problems are most prevalent amongst 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 as much as three million are carriers, together with as much as 8% of African-Americans. In the US, the CDC says that SCD can lower life expectancy by as much as 20 years.

Millions of Americans are carriers of the sickle cell trait or beta thalassemia trait, however in response to analysis, solely a small proportion know their standing. This take a look at can empower folks to shortly be taught their standing, which can affect household planning or different vital selections.”

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,” stated 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 underneath grant award quantity 2R44HL140739-04. The content material is solely the duty of the authors and doesn’t essentially characterize the official views of the National Institutes of Health.