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Roche Submits Application for Clearance of Chlamydia and Gonorrhoeae Test
Date:5/6/2011

PLEASANTON, Calif., May 6, 2011 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has filed for FDA clearance of its Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) tests.

When cleared this standardized and fully automated test will help physicians detect and subsequently treat patients with the disease. Clinical trial data will be presented at the 21st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, May 7-13, Milan, Italy) demonstrating the effectiveness of the assay using multiple sample types. The test is suitable for use in a broad range of settings and laboratories. Roche was the first company to offer a Polymerase Chain Reaction (PCR) based CT/NG test. This latest offering builds on that legacy while introducing novel features that meet customer needs.

"We are pleased to submit for review this innovative test that will address a key medical need," said Paul Brown, Ph.D., Head of Roche Molecular Diagnostics. "With this test Roche will expand the menu on the recently approved cobas 4800 platform currently in use in the US for HPV testing and so continue to improve the workflow for laboratories."

About ChlamydiaChlamydia is the most common bacterial Sexually Transmitted Disease (STD) with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the long-term consequences of untreated disease, as well as lowering the cost of this STD to society.  The Center for Disease Control recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.

About cobas 4800 CT/NG testThe test runs on the fully automated cobas 4800 platform which was recently introduced in the US concurrent with the approval of Roche's HPV test.

The cobas CT/NG  test is a qualitative in-vi
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SOURCE Roche
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