Washington D.C [US], Dec. 5 : In a recent study conducted at the Case Western Reserve University, researchers have developed a portable sensor that can assess the clotting ability of a person's blood 95 times faster than current methods-using only a single drop of blood.
Even better, the device provides more information about the blood than existing approaches. 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.
This week, XaTek, a new Cleveland-based company, licensed the technology for the device-called ClotChip-with a goal of bringing it to market within the next three years.
"ClotChip is designed to minimize the time and effort for blood-sample preparation. [It 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," said Pedram Mohseni, who led the development of ClotChip with Michael Suster.
Existing measures typically require patients to visit laboratories where expert technicians administer tests, an approach that typically is time-consuming and expensive.
While a few methods exist to allow on-site testing, to date they have not proved as nearly as precise as laboratory-based versions.
In preliminary tests, however, the technology provided results in 15 minutes, as compared to conventional measures that can take a day or longer to yield results.
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.
TSOAC 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, "there's a huge opportunity and need," said John Zak, the president and CEO of XaTek.
Adding, "There's no readily available point-of-care, cost-effective and accurate way to monitor these drugs." 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.
To monitor clotting, ClotChip uses an electrical technique called miniaturized dielectric spectroscopy, an approach that the 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. 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.
Earlier, 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.
"Our device gives you different information-and more information-than other devices out there," Stavrou said.
"The sensitivity and discriminatory ability of the device, when compared to standard coagulation tests, is what excites me very much." 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..