HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease R...( MADISON N.J. June 18 /- HemoCue(R...)

MADISON, N.J., June 18 /PRNewswire-FirstCall/ -- HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE: DGX), today announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening for, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the U.S. Food and Drug Administration (FDA). With the FDA CLIA waiver, non-laboratory trained physicians and other health care professionals in any health care facility with a CLIA Certificate of Waiver in the U.S. will be able to use the HemoCue Albumin 201 System to screen patients for microalbuminuria and begin treatment based on the test's results during a single office visit.

Microalbuminuria may indicate the presence of chronic kidney disease (CKD), a life-threatening condition that affects approximately 26 million Americans. Diabetes and hypertension are the two leading risk factors for developing CKD. Microalbuminuria also is an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension.

"Given that microalbuminuria is a risk marker for cardiovascular disease, and its increase over time can indicate kidney disease, it is important that physicians have a fast, easy, reliable test to assess changes in their patients," said professor George L. Bakris, M.D., Director of the Hypertensive Diseases Unit at the University of Chicago-Pritzker School of Medicine. "The availability of a point-of-care test that accurately measures albumin in urine is expected to have a positive impact on physicians' ability to screen in-office and then begin treatment for patients at risk for microalbuminuria, such as
'/>"/>