ClotChip Receives FDA Breakthrough Device Designation For Real-Time Coagulation Testing

Cleveland-based XaTek Inc. announced receiving FDA Breakthrough Device designation for ClotChip, a handheld device that can measure a patient’s bleeding risk profile from a single drop of blood.

The main advantage of ClotChip is that it produces results in 15 minutes, versus the many hours that traditional lab work currently takes. The dramatic decrease in wait time could be important for trauma patients, hemophiliacs, and millions of people taking new-generation anticoagulants.

ClotChip uses technology that was conceived nearly ten years ago by electrical engineers at Case Western Reserve University. The device estimates bleeding risk using a method called dielectric spectroscopy, which quantitatively measures how a blood sample affects an externally applied electric field. It detects markers of coagulation activity in real time, and also provides information about the clotting status of patients taking new-generation blood thinners.

“This is a very important capability,” said Alvin H. Schmaier, MD, chief of benign hematology at Case Western in a press release. “Since there are no tests now in use that can detect the degree to which these drugs have thinned the blood, or tell clinicians of the patient’s bleeding risk, a potential risk of excessive bleeding can’t be assessed.”

“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,” said John Zak, XaTek’s co-founder and CEO in a statement. “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.”

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