Measuring Blood Clotting Ability

Hand-held monitor set for larger clinical trials

Close up photo of the ClotChip devicePHOTO: Nottingham Spirk / Courtesy of XaTek

Using a drop of blood, the handheld ClotChip device can assess a person's blood-clotting ability in about 15 minutes and then send results to a physician using Wi-Fi or Bluetooth.

ClotChip, a portable blood-testing device initially developed at Case Western Reserve, is a step closer to U.S. Food and Drug Administration review after drawing more than $9 million in investments.

The hand-held device would allow people with various blood-coagulation disorders to test their clotting ability and receive immediate results.

John Zak, MD (MED '96), president and CEO of XaTek, a Cleveland-based startup formed to commercialize ClotChip, said the device is unique because, unlike testers now on the market, it can measure the effects of newer anti-clotting drugs and holds potential for testing certain blood conditions, such as hemophilia.

A university research team led by Pedram Mohseni, PhD, professor of electrical engineering and computer science, developed the device's sensing technology.

The idea for the instrument came in 2010 when then doctoral student Mehran Bakhshiani, PhD (GRS '15, electrical engineering and applied physics) was working with Mohseni and senior research associate Michael Suster, PhD (CWR '02; GRS '04, '11, electrical engineering and applied physics), to develop a technology to measure the response of certain liquids to an external electric field.

The researchers knew their technology could have broader applications. Zak suggested applying it to a drop of blood to assess clotting ability, which led to more research and refinements, with doctoral student Debnath Maji focused on that application.

Zak and Nottingham Spirk, a Cleveland design-innovation firm, subsequently created XaTek in 2016. It licensed the technology from the university and secured the funds for clinical trials. The technology is co-owned by the university (which is a XaTek shareholder) and the U.S. Department of Veterans Affairs.

Pilot trials are underway. Two larger-scale trials, one focused on hemophilia and the other on a new class of blood thinners, likely will start in 2020. They will be led by the School of Medicine's Sanjay Ahuja, MD (MGT '14), an associate professor of pediatric hematology/oncology and the Dominic Piunno Endowed Chair in Hemophilia & Bleeding Disorders at University Hospitals Cleveland Medical Center, and Evi X. Stavrou, MD, the Oscar D. Ratnoff Professor of Medicine and Hematology, who also is medical director of the Anticoagulation Clinic at the VA Northeast Ohio Healthcare System.

The team aims to secure FDA approval by 2021, Mohseni said.

—Jon Katz