News | November 01, 2007

Two Point of Care Tests From Quest Diagnostics Get FDA 510(k) Clearance

November 2, 2007 - Quest Diagnostics Incorporated today said its HemoCue and Focus Diagnostics subsidiaries received FDA 510(k) clearance for the HemoCue White Blood Cell (WBC) Analyzer and HerpeSelect Express HSV-2, a test for the diagnosis of the herpes simplex type-2 virus.

The HemoCue White Blood Cell (WBC) Analyzer is a whole-blood test performed on finger-stick samples that assists physicians diagnosing infection, inflammation, bone marrow failure, autoimmune diseases, drug toxicity, leukemic neoplasia and many other medical conditions now routinely tested for by reference laboratories.

The HemoCue WBC Analyzer provides a count of a patient’s white blood cells in as few as three minutes using a blood sample taken from the patient’s fingertip. Unlike conventional methods which measure red and total blood cell counts, the company said the HemoCue WBC Analyzer is the first point of care device to produce quantitative results of a patient’s white blood cells.

Focus Diagnostics’ HerpeSelect Express HSV-2 will aid in detecting genital herpes. It is designed to be simple enough for use in clinics and other point of care settings, and can produce results within fifteen minutes. The ability of physicians to provide counsel on treatment options and lifestyle changes during a single office visit can benefit patients who are anxious about their test results or who may be unwilling or unable to return for a second visit to learn their results. The prevalence of herpes has increased dramatically in the last three decades because it is often transmitted without the knowledge of the infected individual or the uninfected partner. Today more than 50 million individuals in the U.S. are infected and 90 percent are unaware they have the disease.

For more information: www.questdiagnostics.com, www.hemocue.com, www.focusdx.com

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