Roche seeks FDA clearance for fully automated Chlamydia and gonorrhoeae test

May 7 2011

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."