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Roche Gets FDA OK for Four Specimen Types in CT/NG Testing

NEW YORK (GenomeWeb News) – Roche announced today that the US Food and Drug Administration has granted 510(k) clearance for four additional specimen types for use with the firm's cobas CT/NG v2.0 test, which helps physicians diagnose Chlamydia trachomatis and Neisseria gonorrhoeae infections in symptomatic and asymptomatic patients.

The test can 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 test already is used with self-collected vaginal swabs and male urine specimens.

The FDA first cleared the cobas CT/NG test in early 2012.

"With the addition of these specimen types, the cobas CT/NG v2.0 Test now provides US labs with a comprehensive offering for chlamydia and gonorrhea testing," Paul Brown, head of Roche Molecular Diagnostics, said in a statement. "This will enable more labs running the cobas 4800 System to combine CT/NG and HPV testing onto a single automated platform and further optimize their workflow."

The cobas HPV test was initially cleared for marketing by the FDA in April 2011, with a new workflow on the cobas system approved by the agency this past June.