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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

for distribution to more than 30 countries in Europe during the fourth quarter of 2005.

About CLIA Waiver

The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish federal quality standards for the clinical laboratory testing industry. The FDA grants CLIA waivers to FDA 510(k)-cleared tests that are "simple" and have an "insignificant risk of producing an erroneous result." CLIA waived tests may be performed by non-laboratory trained health care workers at any facility that fulfills certain minimal requirements, such as holding a CLIA Certificate of Waiver and following manufacturer instructions.

About HemoCue

HemoCue, a Quest Diagnostics company, is a leading global company in a field of diagnostics known as near patient, or point-of-care, testing. In 1982, HemoCue introduced the first system making accurate hemoglobin testing possible in near patient settings. The system consists of a handheld instrument and a disposable microcuvette (micro sample collection system) used with each test. Since then, HemoCue has sold more than 250,000 systems worldwide and sells more than 100 million test cuvettes annually. The company has subsidiaries and affiliates in the U.S., Germany, Finland, Switzerland, the Netherlands, and the UK, with franchises and third-party distributors generating revenue in more than 100 countries. Quest Diagnostics acquired HemoCue in 2007. HemoCue is based in Angelholm, Sweden. Additional information is available at http://www.hemocue.com.

About Quest Diagnostics

Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensi
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SOURCE Quest Diagnostics Incorporated
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