Glucose Monitoring System Approved In U.S.
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Glucose Monitoring System Approved In U.S.

SAN DIEGO, CA -- December 4, 1997 -- The United States Food and Drug Administration (FDA) has granted marketing clearance to LXN Corp.'s duet glucose control monitoring system. The patented duet system is the first product to combine fingerstick tests for both blood glucose and glycated protein (fructosamine) on one easy-to-use hand-held meter.

Beginning in January, the product will be available as a self-test for persons with diabetes and also as a point-of-care tool for healthcare professionals.

LXN's glycated protein test, sold under the tradename GlucoProtein(TM), measures overall glucose control for the previous two week period and is the first and only glycated protein test ever to be cleared for use outside the clinical laboratory.

The company expects that its Duet System will be especially valuable to persons with type II diabetes, a group that the American Diabetes Association estimates to comprise more than 90 percent of the nearly 17 million Americans with diabetes. Persons with type II diabetes face the same risk of disease complications as those with type I, yet they are known to be poorly compliant with recommended test frequencies for both glucose and glycated protein.

The GlucoProtein test is more sensitive than glycated hemoglobin (HbA1c) to recent changes in glucose control. The test measures the average of continuous glucose levels over the prior two-week period, whereas HbA1c indicates the average over a two to three month period. LXN also plans to aggressively market the Duet System as an in-office test to healthcare professionals.

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