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."