$3 million federal grant awarded to Hemex Health to develop first point-of-care sickle cell testing device for U.S. market; technology developed by CWRU engineer

A private company’s effort to bring its portable point-of-care test for sickle cell disease (SCD) and other inherited blood diseases to the United States is supported by technology developed at Case Western Reserve University.

The National Institutes of Health (NIH) is funding an initiative by Hemex Health Inc.—with support from Case Western Reserve engineer Umut Gurkan—to advance commercialization of the company’s device. That effort includes pursuing and securing U.S. Food and Drug Administration approval for use in the United States.

Clinicians in 27 countries across India, Africa, the Middle East and Southeast Asia already use the device, known as the Gazelle® Hb Variant Test, to test for beta thalassemia and SCD—a disease that affects about 100,000 Americans and about 20 million people worldwide.

U.S. patients can get tested for those diseases at hospitals and medical offices, but the blood samples must then be sent to a central lab, which delays analysis and treatment, Gurkan said. So, U.S. patients could benefit from point-of-care testing with immediate results, he said.

“Getting more people tested for the sickle cell trait or beta thalassemia trait is especially important because only about 16% of the people carrying the trait are aware that they are,” said Gurkan, the Wilbert J. Austin Professor of Engineering Case Western Reserve. “Knowing this before passing it on to potential children, for example, would be important information.”

The NIH earlier this year awarded a three-year, $3 million grant to Hemex for the initiative. Oregon-based Hemex first licensed Gurkan’s technology from Case Western Reserve in 2016.

Gurkan, through Case Western Reserve, is using a portion of the grant to refine his patented technology (microchip electrophoresis) used to separate molecules by size and electrical charge.

The Gazelle device

Gazelle debuted in June 2020, just before the annual June 19 World Sickle Cell Day.

Gazelle’s results are equivalent to standard lab tests, but don’t require the complex logistical support or technical expertise found in a hospital laboratory, the company said.

Research has found Gazelle 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.

“Understanding of sickle cell status in the U.S. is surprisingly low,” said Hemex Health CEO Patti White. “By bringing affordable, easy-to-use testing to the point of care, Hemex aims to equip more clinicians to test for SCD, which will also bring more attention to this disease.”

SCD a global problem

SCD results from a single genetic mutation that causes a person’s red blood cells to form an abnormal, sickle shape.

The Centers for Disease Control and Prevention (CDC) says SCD can decrease life expectancy by up to 20 years.

It’s especially common among those whose ancestors came from sub-Saharan Africa, among other areas, according to the CDC.