New high throughput test offers expanded sample claims and enables increased laboratory efficiency
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE-IVD launch of 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 is the first CE-IVD cleared molecular test for CT/NG to receive claims for the testing of anorectal and oropharyngeal samples, providing broader access to a high risk patient population. The inclusion of extragenital specimen testing is needed in certain patient populations as more than half of CT and NG infections may be missed when only testing traditional urogenital specimens.1 The expanded claims are in addition to claims for male and female urine specimens, endocervical swab specimens, clinician-collected and clinician-instructed patient self-collected vaginal swab specimens – all collected in cobas® PCR media – and cervical specimens collected in PreservCyt® Solution.
“The addition of cobas® CT/NG to our expanding cobas® 6800/8800 Systems menu provides laboratories with the highest throughput solution for the testing of CT/NG on the market,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “The efficiency that cobas® CT/NG enables by providing exceptional assay performance, exemplary workflow and an extremely flexible testing solution, frees up laboratory staff to perform other tasks, and ensures that accurate and rapid results are reported to clinicians to aid in improved patient management.”
The fully automated cobas® 6800/8800 Systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands.
Chlamydia trachomatis is the most common bacterial Sexually Transmitted Disease (STD), with the highest prevalence among youth. Routine screening for chlamydial infection in young women has been demonstrated to reduce infection rates and the long-term consequences of untreated disease, as well as lowering the financial burden on the healthcare system. The Centers for Disease Control and Prevention (CDC) recommends annual Chlamydia trachomatis screening for all sexually active females under 25 years old and additional testing for pregnant women and those with risk factors.
Neisseria gonorrhoeae is the second most commonly reported bacterial STD in the United States. Infections in males are generally symptomatic, motivating infected patients to seek evaluation by a clinician for identification and treatment before the onset of serious complications. Gonococcal infections in women are often asymptomatic and may not be immediately recognized, which can progress to Pelvic Inflammatory Disease, tubal scarring, infertility and ectopic pregnancy. Screening of sexually active women under the age of 25 and those at high risk for infection is the focus of successful detection programs in the United States.
About the cobas® 6800/8800 Systems
The cobas® 6800 and cobas® 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health and microbiology. Based on Nobel prize-winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.
The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the cobas® 6800 System and 960 results for the cobas® 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas® 6800) and four hours (cobas® 8800) of walk-away time with minimal user interaction.
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- Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae — 2014, Recommendations and Reports / Vol. 63 / No. 2 March 14, 2014, 10-11.
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Todd Siesky, Roche Molecular Diagnostics