Contact: Candace Glider
August 9, 2000
New A1c At HomeTM Mail-In Lab Test for Diabetes Management Now Available to Consumers
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 9, 2000) - FlexSite Diagnostics, Inc. today announced the availability of the A1c At HomeTM Test Kit to consumers. Previously available primarily through managed care and disease management companies, A1c At HomeTM is a convenient, cost-effective and accurate concept in HbA1c (glycohemoglobin) testing.
The A1c At HomeTM Test Kit was the first of its kind utilizing filter paper technology and enabling patients to draw finger-stick blood samples at home for mail-in laboratory measurement of HbA1c levels. Beginning in 1997 the product was introduced and marketed exclusively by Becton Dickinson and Company (B-D) under the label B-D Easy A1CTM. B-D marketed the kits to managed care and disease management companies who have been distributing them to members of diabetes management programs nationwide.
As of January 2000, the developer and manufacturer of the A1c kit, Palm City, Florida-based FlexSite Diagnostics, Inc., reacquired the product and began selling it as A1c At HomeTM. While continuing to do business with managed care and disease management companies, FlexSite has launched a major campaign to make the kits available directly to the consumer. Distributors such as independent pharmacies, durable medical supply companies (DMEs), and online pharmacies are beginning add A1c At HomeTM to their diabetes product lines and kits can also be ordered directly from FlexSite by calling toll free, 1-877-212-8378 or online at www.flexsite.com.
HbA1c testing is considered the most important test for long term diabetes management. While glucose monitoring is vital for day-to-day diabetes management, long-term blood glucose control requires the measurement of average blood glucose levels. The most accurate measurement of the average glucose level, according to the landmark Diabetes Control and Complications Trial (DCCT), is the HbA1c or glycated hemoglobin test.
The American Diabetes Association (ADA) recommends HbA1c testing for all people with diabetes at least twice a year, and four times annually for those requiring insulin injections. However, according to a nationwide survey by the American Association of Diabetes Educators (AADE), only 25 percent of people with diabetes know their HbA1c level and less than 20 percent have their HbA1c tested regularly.
"We want to make HbA1c testing accessible and affordable to all people with diabetes," says Sam Martin, President and CEO of FlexSite Diagnostics. "The ADA Standards clearly are not being met. It's up to all of us who provide products and services to people with diabetes to educate the public and health care professionals about the importance of controlling blood glucose levels. HbA1c testing must become utilized adequately."
Lowering HbA1c levels is one of the most important things a patient can do to delay and even prevent the complications of diabetes including blindness, kidney disease, heart disease, nerve disorders and strokes. However, traditional lab testing, which can be expensive, inconvenient and even painful, is not very appealing to many patients.
"We know there are many people with diabetes who would like to improve their blood glucose control, yet they're not having the recommended laboratory tests done," says Martin. "Consequently, we saw a need to empower patients to manage their diabetes in an affordable and convenient manner."
A1c At HomeTM is the first product in FlexSite Diagnostics' line of at-home mail-in laboratory tests for diabetes management. Other products will include the UriSiteTM Urine Collection Kit for Microalbumin/Creatinine Testing, which is used to screen for kidney dysfunction, and a Cholesterol Profile Kit that measures cholesterol, HDL cholesterol and triglycerides, and provides a computed LDL cholesterol.
The UriSiteTM Urine Collection Kit for Microalbumin/Creatinine Testing is currently being reviewed by the U.S. Food and Drug Administration (FDA). Pending FDA marketing clearance for over-the-counter (OTC) sales, this product could be available by the fourth quarter of 2000.
For more information about 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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