Using the ProTime Microcoagulation System, a patient pricks a finger to draw a blood sample and runs the sample through a small, hand-held electronic device that displays results on a screen. The home prescription version will be for use under a doctor's supervision. Previously, patients taking Coumadin had a PT test every one or two months during regular visits to their doctor. With the new kit, they can test themselves weekly, or as often as their doctor recommends. The system stores the 40 most recent results with a date and time stamp, enabling the doctor to review and interpret results and adjust the drug if needed.
Doctors can program the appropriate upper and lower blood-clotting ranges for each patient.
FDA cleared the device after reviewing data on 84 patients at four clinics. The patients had the professional laboratory PT test at the clinics and also tested themselves with the home kit. Both types of tests showed comparable results. International Technidyne Corp., Edison, N.J., makes the ProTime Microcoagulation System. New Uses For Drugs and Biologics Ways to speed development of new and supplemental uses for approved drugs and biological products using all available data to determine effectiveness are being explored by FDA under a proposed plan.