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Roche receives FDA clearance to use additional specimen types for chlamydia and gonorrhea test
Date:12/4/2013

4; 4800 System to combine CT/NG and HPV testing onto a single automated platform and further optimize their workflow."

The test is performed on the cobas® 4800 System, which is currently the only FDA-approved system to offer primary vial loading for both CT/NG and HPV testing. The streamlined workflow can help labs reduce costs, improve turnaround time and free staff to spend time on other critical tasks.

About the cobas® CT/NG v2.0 Test
The cobas® CT/NG v2.0 Test is a qualitative in-vitro test for the detection of CT/NG DNA in patient specimens. It utilizes amplification of target DNA by Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of CT/NG in a single analysis.

About the cobas® 4800 System
The cobas® 4800 System offers true walk-away automation of nucleic acid purification, PCR set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas® HPV Test, the cobas® BRAF V600 Mutation Test and the cobas® EGFR Mutation Test.

About Chlamydia
Chlamydia 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.

About Gonorrhea
Gonorrhea 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 c
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