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

HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE:DGX), 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...

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