ClotChip, a portable device designed to quickly assess the ability of a person’s blood to clot, has been designated a breakthrough device by the U. S. Food and Drug Administration (FDA), its maker XaTek announced.
This designation offers the company additional FDA guidance and the possibility of priority review should a request be filed for the handheld blood-clotting sensor’s approval.
ClotChip measures bleeding risk by analyzing a single drop of blood acquired from a finger prick — similar to how a glucometer measures blood-sugar levels in a person with diabetes. The speed and accuracy with which ClotChip analyzes clotting factors in patients’ blood may be crucial when it comes to saving a life, the company reports.
It is based on technology called miniaturized dielectric spectroscopy that was developed about a decade ago by engineers at Case Western Reserve University. By applying an electric field to a droplet of blood, it can measure how the droplet influences the field around it. Data from ClotChip can then be transferred to other devices using Wi-Fi or Bluetooth.
“I’m tremendously proud of the entire XaTek team and their remarkable efforts, which lead the FDA to believe ClotChip indeed satisfies all of the criteria for Breakthrough Devices Designation for the proposed indication for use,” John Zak, co-founder and chief executive officer of XaTek, said in a press release.
“Once commercially available, this device will fulfill a critical and unmet clinical need for the newer generation of drug therapies known as ‘direct oral anti-coagulants’ — for which there is no point-of-care test available today,” Zak added.
Direct oral anticoagulants are anti-coagulant substances, also known as blood thinners, that target and block the activity of specific blood factors to prevent blood from clotting.
ClotChip can be used for point-of-care testing for direct oral anticoagulants, informing physicians about a patient’s condition and response to treatment.
The company plans to extend ClotChip’s current indication to include patients on anti-coagulant therapies, those with hemophilia and other rare bleeding disorders, and trauma-related conditions.
Case Western granted an exclusive license to XaTek to develop the technology for commercial use in 2016. The company recently raised $9.1 million to advance work on developing and testing ClotChip.
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