Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k)...( First step for performing importa...),Health

First step for performing important diagnostics in physician offices

MADISON, N.J., Nov. 1 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX), the nation's leading provider of diagnostic testing, information and services, today announced that its HemoCue and Focus Diagnostics subsidiaries have received FDA 510(k) clearance for two new point of care tests. The HemoCue(R) 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 company also received FDA clearance for Focus Diagnostics' HerpeSelect(R) Express(TM) HSV-2, a test for aiding in the diagnosis of the herpes simplex type-2 virus, the primary cause of genital herpes. This is the first step in the regulatory process that allows the companies to market the products and file for CLIA waivers, which would enable the tests to be used in a much larger segment of physician offices. The $6 billion market for point of care tests is growing an estimated eight percent to ten percent a year.

"The HerpeSelect Express HSV-2 test and HemoCue WBC Analyzer are important technologies that underscore the growing importance of point of care tests as complements to laboratory-based diagnostics," said Joyce G. Schwartz, M.D., vice president and chief laboratory officer, Quest Diagnostics. "These two tests could markedly change the speed of diagnosing infections, allowing physicians to make immediate treatment decisions for their patients."

The HemoCue WBC Analyzer provides a count of a patient's
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