Breakthrough Diabetes Measurement Kit Cleared for Marketing
Becton Dickinson's B-D EASY A1C(TM) Test Kit Will Enable Patients To Measure Crucial Diabetes Indicator from Home
FRANKLIN LAKES, N.J. Sept. 11 /PRNewswire/ -- Becton Dickinson and Company (NYSE:BDX) announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing a new kit for measuring long-term blood glucose levels, an important health indicator for people with diabetes. The B-D EASY A1C(TM) kit--the first of its kind--will enable patients to draw samples at home for mail-in laboratory measurement, offering greater convenience than current testing methods that can require a visit to a laboratory or medical professional's office.
Using the B-D EASY A1C kit, patients will be able to determine their levels of glycated hemoglobin, a blood component long recognized as an accurate, valuable indicator of long-term levels of glucose, or sugar, in the blood. Glycated hemoglobin is sometimes referred to as hemoglobin A1c, or "HbA1c." At any given time, a patient's HbA1c level corresponds closely to his or her average glucose level for the previous four-to-eight-weeks. Unlike the monitoring of day-to-day glucose levels--a necessary activity for many people with diabetes--measuring HbA1C levels provides a long-range perspective on how glucose levels are being controlled.
Glycated hemoglobin is formed when glucose is attached to hemoglobin, the component of red blood cells that carries oxygen. Levels of glycated hemoglobin rise when blood glucose levels are consistently elevated; they fall when levels are reduced.
"HbAlc measurements are an essential tool for optimal diabetes management," said Barry H. Ginsberg, MD, PhD, corporate medical director, worldwide diabetes healthcare at Becton Dickinson and Company. "Regular tests of HbAlc, in combination with daily monitoring of blood glucose levels, provide patients and their physicians with the information they need to design diabetes-management programs that offer significant long-term health benefits."
The B-D EASY AlC test kit was developed, and cleared for marketing through the FDA, by Flexsite Diagnostics, Inc., a closely held medical diagnostic corporation that is developing remote site diagnostic sampling kits for use in the diagnosis and monitoring of several disease states.
Convenience and Long-term Information Users of the B-D EASY A1C kit will, with a simple fingerstick procedure, draw two drops of blood and place them on a specially treated test strip, which they then send to a laboratory in a prepaid mailer. Within seven to ten days, both patients and their doctors will receive test results. Once enrolled in the B-D EASY A1C program, patients can receive a new test kit via mail every three months. Over time, the B-D EASY A1C program will provide information on prior B-D EASY A1C test results along with new results, so users can identify trends in the course of their long-term blood glucose levels.
Although users will be able to conduct the test without assistance, they are encouraged to discuss the significance of their results with their health care professional. Based on results of the B-D EASY A1C test, users, with their doctor's advice, may wish to modify their diabetes-management programs in order to optimize long-term blood glucose control.
The American Diabetes Association recommends that people with diabetes test their HbA1c levels regularly. Studies have shown that long-term reductions in HbA1c are associated with a dramatically reduced risk of major diabetes complications, including amputations, loss of vision and kidney failure.
"Controlling blood glucose levels is one of the most important steps a person can take to minimize the complications of diabetes," said Ken Weisshaar, senior vice president at Becton Dickinson and Company. "B-D EASY A1C test kit offers people with diabetes a way to get an accurate, big-picture view of their glucose levels wherever and whenever it's most convenient."
The B-D EASY A1C kit represents an important advance in Becton Dickinson and Company's longstanding commitment to people with diabetes. The kit is expected to be made available for use in early 1998.
Becton Dickinson and Company, a leader in diabetes care, manufactures a broad range of medical devices and diagnostic systems and supplies for use by health care professionals, medical research institutions and the general public. Celebrating its 100th anniversary in 1997, Becton Dickinson and Company is committed to improving and enhancing delivery of diabetes health care.
Posted 13 Sep 97
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