Contact: Candace Glider
August 28, 2000
Unique Mail-In Test to Screen Diabetics for Kidney Dysfunction Cleared by FDA for Marketing
For the first time, individuals with diabetes will be able to initiate the microalbumin/creatinine laboratory test in the privacy of their homes.
PALM CITY, FLORIDA (August 28, 2000) - FlexSite Diagnostics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared for marketing its UriSiteTM Urine Collection Kit for Microalbumin / Creatinine Testing. This kit will enable diabetes patients to collect a urine sample at home for mail-in laboratory testing. The Microalbumin / Creatinine test is used to detect small amounts of protein (microalbumin) in the urine, an early sign of kidney dysfunction.
While kidney disease is one of the most devastating complications of diabetes, it's also highly detectable and treatable in its earliest stages. The American Diabetes Association (ADA) and the American Kidney Foundation (AKF) recommend that everyone with diabetes be tested for microalbuminuria every year. However, studies have shown that this test is widely underused.
With this new kit, the urine sample is mailed in a dried state to FlexSite Diagnostics' CLIA licensed laboratory using the proprietary UriSiteTM urine collection device. This product is designed for the patient and physician to use together to monitor the patient's health and help achieve improved diabetes management.
"It's well documented that kidney disease is one of the most controllable complications associated with diabetes," says Sam Martin, President and CEO of FlexSite Diagnostics. "Yet, the key to that control is early diagnosis and education, which unfortunately has significantly lagged behind most other diabetes diagnostic testing."
Martin says the UriSiteTM Urine Collection Kit for Microalbumin / Creatinine Testing is projected to be available by the first quarter of 2001. This will be the second product in FlexSite Diagnostics' line of at-home mail-in laboratory tests for diabetes management. The first product, A1c At Homeä, offers patients a convenient and affordable way to do glycohemoglobin (HbA1c) testing. This test, which measures average blood glucose levels over a period of about three months, is considered the most important test for long term management of diabetes.
FlexSite's next product, which is in development, is a Cholesterol Profile Kit that measures cholesterol, HDL cholesterol and triglycerides, and provides a computed LDL cholesterol.
For more information about the UriSiteTM Urine Collection Kit for Microalbumin / Creatinine Testing, A1c At HomeTM or upcoming products, call FlexSite Diagnostics toll free, 1-877-212-8378 or visit their web site at www.flexsite.com.
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Posted 29 August 2000
Last Updated: Thursday August 29, 2002 20:59:48
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