The portable device known as the ClotChip is based on technology developed by Case Western Reserve University researchers. Case Western Reserve’s Technology Transfer Office negotiated a licensing agreement between the university and the company. XaTek wants to bring the ClotChip to market within the next three years. Pedram Mohseni, professor of electrical engineering and computer science (EECS) at Case Western Reserve, led the development of ClotChip with Michael Suster, senior research associate in the EECS department.
Rapid, accurate assessments essential
Rapid and accurate assessments are essential to ensuring that patients prone to blood clots—as well as those who have difficulty clotting—receive care appropriate to their conditions. With this in mind the Case Western researchers set out to develop the ClotChip technology. It’s designed to minimize the time and effort for blood-sample preparation and can be used at the doctor’s office or other points of care for patients on anticoagulation therapy, antiplatelet therapy or who have suffered a traumatic injury causing bleeding.
Existing measures typically require patients to visit laboratories where expert technicians administer tests, an approach that typically is time-consuming and expensive. A few methods already allow on-site testing, but to date they have not proved as nearly as precise as laboratory-based versions. However, Case Western Reserve’s technology provided results in 15 minutes in preliminary tests, as compared to conventional measures that can take a day or longer to yield results.
Information about coagulation process
ClotChip also provided more information about the coagulation process, including the effects of a new class of drugs called target-specific oral anticoagulants, or TSOACs. These drugs block clots from forming in a different way than warfarin (most commonly known by the brand name Coumadin), which had dominated the market for decades.
Warfarin, however, can interact negatively with several medications and foods and also requires frequent blood tests to monitor the drug’s effects. The new medications, including rivaroxaban (Xarelto) and apixaban (Eliquis) have been marketed extensively as far more convenient alternative. To date, however, the U.S. Food and Drug Administration (FDA) has not approved a device to determine the impact of the new drugs.
With the market share of TSOACs growing rapidly, John Zak, president and CEO of XaTek beleives there is both a huge opportunity and need for devices such as the ClotChip. “There’s no readily available point-of-care, cost-effective and accurate way to monitor these drugs.”
The CEO said that the company hopes to complete a pilot clinical study and data analysis of ClotChip use on 200 patients at the Louis Stokes Cleveland VA Medical Center by the third quarter of 2017. If the device proves effective in that initial evaluation, the company would seek to launch a full clinical trial within the following two years; from there, XaTek would seek FDA approval.
Miniaturized dielectric spectroscopy
To monitor clotting, ClotChip uses an electrical technique called miniaturized dielectric spectroscopy, an approach that Mohseni, Suster and their team began developing six years ago. In essence, the technique applies an external electric field to the drop of blood, then quantitatively measures how the blood affects that field. The measurements reflect the ability of the blood to clot.
Two years ago, the engineering researchers began collaborating with Evi Stavrou, an assistant professor of hematology and oncology at Case Western Reserve School of Medicine. Together they found that ClotChip’s sensitivity to the blood coagulation process made it an appealing option for point-of-care testing.
Earlier this year, the engineering researchers shared preliminary findings in a paper that was part of the 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society. On Monday, Stavrou will present the technology at the American Society of Hematology annual meeting; her abstract represents the first peer-reviewed dissemination of tests involving samples for more than 30 volunteers.
Because the device works so quickly, emergency responders could use it on site to determine whether a patient in trauma is on one of the blood-thinner medications. Such critical information also could be invaluable to medics in wartime.