MADISON, N.J. and CYPRESS, Calif., May 5, 2011 /PRNewswire/ —
Quest Diagnostics Incorporated (NYSE:
DGX), the world’s leading provider of diagnostic testing,
information and services, today announced the availability in
Europe of the Simplexa C. difficile Universal Direct test on
the 3M™ Integrated Cycler. The new CE marked in vitro
diagnostic (IVD) Simplexa test enables fast, high volume lab
testing, eliminating the traditional extraction step and allowing
for processing of up to 94 patient specimens in about an hour.
Focus Diagnostics, a business of Quest Diagnostics and developer
of the Simplexa product line, will unveil the new test as well as
the Simplexa Epstein Barr (EBV) and BK Virus tests, which were CE
marked last month, during the European Congress of Clinical
Microbiology and Infectious Disease Tradeshow, which begins on May
7 in Milan (Exhibit number: 241). A CE mark is a regulatory
requirement to sell products in about 35 countries in Europe.
Simplexa tests, running on the 3M™ Integrated Cycler,
employ real-time polymerase chain reaction (RT-PCR) to
qualitatively and quantitatively detect viruses, bacteria and other
agents. The Simplexa C. difficile Universal Direct test is
performed on liquid or unformed human stool samples and detects
toxin producing strains of Clostridium difficile, including
NAP1/B1/027.
“Clostridium difficile is a common cause of
antibiotic-associated diarrhea and an extremely important and
serious hospital-acquired infection,” said Jay M. Lieberman, M.D.,
medical director for Quest Diagnostics and Focus Diagnostics.
“C. difficile infections (CDI) range in severity from
mild diarrhea to life-threatening pseudomembranous colitis, and
result in significant suffering and deaths. Timely diagnosis is
essential for clinicians when treating patients presenting with
possibl
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