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Roche receives FDA clearance to use additional specimen types for chlamydia and gonorrhea test
Date:12/4/2013

PLEASANTON, Calif., Dec. 4, 2013 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of four additional specimen types with the cobas® CT/NG v2.0 Test to help physicians diagnose Chlamydia trachomatis (CT) and Neisseria Gonorrhoeae (NG)  infections in symptomatic and asymptomatic patients. In addition to self-collected vaginal swabs (collected in a clinical setting) and male urine specimens, the test may now be used with endocervical and clinician-collected vaginal specimens, female urine specimens collected in cobas® PCR media, and cervical specimens collected in PreservCyt® solution.

The clinical performance of the cobas® CT/NG v2.0 Test using the additional specimen types was validated in the VENUS Studies, which included 6,004 patients (5,266 females and 738 males), representing over 26,000 specimens collected in two clinical studies.

"International efforts directed at reducing the CT/NG burden through more timely and accurate detection of CT/NG will be accelerated by diagnostic testing which allows for identification of both symptomatic and asymptomatic patients," said Dr. Jane Gibson, Ph.D. Professor of Pathology, University of Central Florida Health Sciences Campus. "The cobas® CT/NG v2.0 Test has demonstrated consistent, dependable performance using a broad spectrum of approved sample types, which provides laboratories with a highly efficient tool for use in both routine screening and diagnostic patient testing."

"With the addition of these specimen types, the cobas® CT/NG v2.0 Test now provides U.S. labs with a comprehensive offering for chlamydia and gonorrhea testing," said Paul Brown, head of Roche Molecular Diagnostics. "This will enable more labs running the cobas
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