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 possible C. difficile disease."
"Our Simplexa C. difficile Universal Direct test will help physicians make a fast, reliable diagnosis of CDI," says Dr. John Hurrell, General Manager at Focus Diagnostics. "This is vital to treating patients and reducing the threat of transmission to other patients."
CDI is a bacterial infection that most commonly affects patients on prolonged use of broad spectrum antibiotics, over 65 in age, and those who have recently undergone gastrointestinal surgery or are immunocompromised. In major European Union (EU) countries, such as Belgium, Denmark, France, Germany, Italy, Netherlands, Spain and the United Kingdom, CDI is estimated to be responsible for 1.1 in 1,000 hospital admissions and is expected to double over the next four decades. The European Center for Disease Prevention and Control estimates the financial impact of each CDI case in England can cost euro 5.000 – 15.000. With a European population of 457 million, the potential cost to the Union may exceed euro 3.000 million annually.
Focus Diagnostics launched the Simplexa molecular product line in 2009 with a focus on influenza and respiratory syncytial virus. Since that time, the Simplexa product line has expanded to include Tests for detecting Flu A/B and Respiratory Syncytial virus, EBV, BK virus and Bordetella pertussis. Simplexa tests run on the 3M Integrated Cycler, a compact, portable testing platform that can provide results in as few as 60 minutes following sample extraction, as part of an exclusive worldwide agreement with 3M.
In April 2011, the Simplexa/3M technology won a 2011 Edison Award for new science and medical diagnostic product, based on criteria that included technological innovation and marketplace success.
SOURCE Quest Diagnostics Incorporated