Roche Announces FDA Clearance for Chlamydia and Gonorrhea Test
2 Feb 2012
Product news
Roche announced yesterday that the U.S. Food and Drug Administration (FDA) has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) infections. The test is designed for use on the cobas 4800 System.
The cobas® CT/NG Test can detect CT and NG infections in symptomatic and asymptomatic patients, from male urine samples and self-collected vaginal swabs. The polymerase chain reaction (PCR)-based multiplex dual probe assay offers excellent sensitivity and high specificity and expands the menu for the cobas 4800 System. Laboratories will now be able to combine the cobas® CT/NG Test and the cobas HPV Test (which received FDA approval in April) onto a single platform.
“This new test will give labs in the U.S. an efficient solution for offering clinicians chlamydia and gonorrhea screening using the preferred specimen types,” said Paul Brown, head of Roche Molecular Diagnostics. “Since it received CE mark in 2009, the test has been very well received by labs outside the U.S. and we are pleased to be able to offer it to the U.S. market.”
Use of male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing, and are considered a progressive option for this type of screening. The samples show high sensitivity, whilst being less invasive and less painful to collect than traditional urethral or endocervical samples. The hope is that this may help to promote screening compliance.
“This test will contribute to lowering the burden of disease by providing accurate results from easy to obtain samples – self collected vaginal swabs from women and first catch urine from males. Allowing patients to be active participants in maintaining their health will encourage screening and facilitate clinic flow,”said Dr. Barbara Van der Pol, assistant professor of epidemiology at the Indiana University School of Public Health.
In addition to the current assays that focus on women’s health, Roche is developing tests for the cobas 4800 System menu in the areas of microbiology and oncology.
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cobas® 4800 PCR system
The cobas® 4800 system provides a platform to perform qualitative in vitro nucleic acid amplification tests for the detection of Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG), and Human Papilloma Virus (HPV) in clinical specimens. The cobas® 4800 system integrates fully automated total nucleic acid isolation directly from primary and secondary sample tubes, automated PCR setup, and real-time PCR. The main features are: Fully integrated sample preparation Amplification and detection using real-time PCR Minimal hands-on time Multiple sample types Multiple tests in one kit Intuitive operation by an easy to use workflow wizard CT/NG (single or dual) and HPV High Risk testing HPV genotyping (HR + 16/18) The cobas® 4800 system combines the following components: cobas x 480 instrument for automated sample preparation cobas z 480 analyser for amplification and detection cobas® 4800 software and control unit cobas® 4800 reagents cobas® 4800 consumables cobas® PCR sample collection kits for collecting urine and swab (endocervical, vaginal) samples One cobas® 4800 system can process up to 376 CT/NG samples or up to 282 HPV samples in a single workday. The first 94 CT/NG results can be obtained in less than 4 hours; the first HPV results can be obtained in less than 5 hours.