Roche Launches Future Proof Chlamydia Test In The UK, Offering More Reliable Detection Of Chlamydia Trachomatis

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Medical Devices / Diagnostics
Article Date: 23 Sep 2008 - 7:00 PDT

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A new test for the detection of Chlamydia trachomatis has received CE Mark certification, allowing it to be sold for clinical use in the UK. Unlike previous tests, the Roche test is designed with a dual target approach to help future proof it, by ensuring reliability of results even when mutations occur in the bacteria's cryptic plasmid DNA. According to the National Chlamydia Screening Programme, Chlamydia trachomatis is the most commonly reported sexually transmitted disease in the UK. Although it often causes no symptoms, Chlamydia can, if left untreated, lead to complications such as pelvic inflammatory disease or infertility in women.

"Unexpected mutations in the DNA of an infectious agent such as Chlamydia can disrupt laboratory testing and, by extension, proper treatment of patients," said Karim Tabiti, International Business Leader for HPV and CT/NG at Roche Molecular Diagnostics. "Because it is impossible to predict when these mutations will occur, we have designed this test to detect all Chlamydia strains that may carry a deletion in the cryptic plasmid, including the variant originally detected in Sweden in 2006."

Chlamydia trachomatis is found in 1 in 10 people under the age of 25 who are tested in the UK. The infection is often referred to as a "silent" sexually transmitted disease because approximately three quarters of infected women have no symptoms. Once detected, Chlamydia trachomatis can easily be treated with antibiotics. If left untreated, health risks can include chronic pelvic pain, pelvic inflammatory disease, potentially fatal ectopic pregnancy, increased risk of HIV infection if exposed, and infertility.

The highly sensitive and reliable COBAS® TaqMan® CT Test v2.0 simultaneously detects two targets within the C. trachomatis cryptic plasmid and genome target DNA. The COBAS® TaqMan® CT Test v2.0 offers real-time PCR testing on the automated COBAS® TaqMan® 48 Analyzer. This automated platform can produce up to 48 tests per run and provide results in only 2.5 hours after sample preparation. Amplification and detection in a closed system combined with Roche's proprietary AmpErase enzyme and internal controls for each test help prevent cross contamination. This enhances test results integrity and quality control in laboratories.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and sales by the Diagnostics Division totalled 9.3 billion Swiss francs. Roche Diabetes Care posted 2007 sales of 3.2 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com

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