FDA Clears Roche’s Chlamydia and Gonorrhea Molecular Tests

Roche announced that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance for cobas CT/NG for use on the cobas 6800/8800 Systems for the direct detection of Chlamydia trachomatis(CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.
 
“cobas CT/NG on the cobas 6800/8800 Systems provides clinicians with results in which they can have high confidence given the excellent sensitivity and specificity of the assay for all relevant sample types,” said Barbara Van der Pol, international expert on STIs and Associate Professor of Medicine, School of Medicine, University of Alabama at Birmingham. “For the laboratory, the platform provides a tech friendly solution that minimizes hands-on time while maximizing the flexibility of incorporating sexually transmitted infection screening with other assays that are currently available on the system.”
 
cobas CT/NG is the first assay available in the US for the testing of sexually transmitted infections on the cobas 6800/8800 Systems. It is cleared for use with male and female urine specimens, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, endocervical swab specimens (all collected in cobas® PCR media) and cervical specimens collected in PreservCyt Solution.
 
“Sexually transmitted infection rates are rising worldwide and the cobas CT/NG helps labs meet increasing testing volumes with highest throughput solution on the market today,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “With exceptional performance, exemplary workflow and a flexible testing solution, the CT/NG helps labs free up staff to perform other tasks while still ensuring clinicians receive accurate and rapid results to aid in patient management.” 
 
Other STI assays are in development and will further allow laboratories to consolidate high volume STI testing on a single platform. In addition to cobas CT/NG, cobas 6800/8800 Systems menu in the US includes viral load monitoring tests for HIV, HBV, HCV and CMV, as well as MPX, WNV, DPX and Zika for use in screening blood donations. Since its introduction in 2015, the fully automated cobas 6800/8800 Systems have offered labs the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.