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HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker
Date:6/18/2008

ertension, be offered microalbumin screening during periodic health evaluations. Microalbuminuria screening can help physicians detect CKD in the early stages -- before symptoms appear -- when treatment can halt or reverse its progression.

Despite evidence-based medical guidelines, a March 2008 Quest Diagnostics Health Trends Report on Chronic Kidney Disease found that only 32.7 percent of patients with type 1 or type 2 diabetes and/or hypertension received a microalbumin test for CKD during the twelve-month period ending in October 2006. The study is based on results of tests performed by Quest Diagnostics on patients in the U.S. Diabetes affects seven percent of the U.S. population and more than 21 percent of adults over age 60. Hypertension affects approximately 30 percent of American adults and more than half of those over age 60.

"Our recent Health Trends data suggest that fewer at-risk patients are receiving microalbumin tests than would be expected if the established medical guidelines were universally applied," said Stephen C. Suffin, M.D., interim chief laboratory officer and corporate clinical pathologist -- science and technology, Quest Diagnostics. "The availability of a fast, reliable point-of-care test that physicians can perform in their own offices to quantitatively assess microalbumin may help patients at risk for CKD to begin receiving the care they need at the time of their appointment with their physician."

In addition to CKD and cardiovascular disease, microalbuminuria may also suggest the potential development of preeclampsia, a potentially life-threatening condition that can affect a pregnant woman, particularly those with type 1 diabetes, and her fetus. In patients with diabetes, microalbuminuria may suggest the potential to develop diabetic retinopathy, the leading cause of blindness among adults in the U.S.

The HemoCue Albumin 201 System received FDA 510(k) clearance in the first quarter of 2006. It was CE marked
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SOURCE Quest Diagnostics Incorporated
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