FDA Clears Two STD Tests for the Roche cobas 4800 Diagnostics System

FDA Clears Two STD Tests for the Roche cobas 4800 Diagnostics System

Fully automated sample preparation with real-time polymerase chain reaction (PCR) technology for amplification and detection

Best combination of technologies available:

cobas x 480 Instrument

Fully automated sample preparation from primary vials

Ready-to-use, load-and-go reagents

No thawing or mixing required

Less than 20-minute set-up for full run of 94 samples

cobas z 480 Analyzer

Real-time PCR with digital data capture provides accurate qualitative results with no gray zone

Eliminates the need for equivocal sample retesting

Advanced results algorithm eliminates the need for manual curve analysis

Features and Benefits

Easy-to-learn and easy-to-use software

Intuitive user interface

Requires only a few hours training at all levels of laboratory personnel

Seamlessly integrates both system components

Streamlines workflow

Fully automated sample preparation

High quality nucleic acid extraction technology

Robust engineering reduces maintenance and downtime

Bi-directional connectivity with an LIS for automated results reporting reduces labor and potential for error

Promotes lab efficiency

Processes up to 384 samples a day

Efficient for labs with lower throughput requirements

Load primary collection tubes and liquid cytology vials directly on the system

Minimal input volumes allow multiple tests from the same patient specimen

Roche receives FDA clearance for test to screen and diagnose chlamydia and gonorrhea infection in symptomatic and asymptomatic patients

New cobas CT/NG test expands cobas 4800 system menu beyond clinically proven HPV test to further enhance laboratory efficiency, automation capabilities

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs. A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia and gonorrhea offers excellent sensitivity and high specificity and runs on the automated cobas 4800 System, complementing the cobas HPV (Human Papillomavirus) Test that received FDA approval in April.

“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.”

Male urine and self-collected vaginal swabs are the preferred specimen types for CT and NG testing, according to the summary report from the U.S. Association of Public Health Laboratories and Centers for Disease Control and Prevention.1 The use of these specimen types is considered a progressive option for CT/NG screening, as they show high sensitivity yet are less invasive and less painful to collect than urethral or endocervical samples and thus may help promote screening compliance. The registrational trial for the cobas CT/NG test also confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen types across patient populations with both low and high disease prevalence.

“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.

The introduction of the new test expands the menu for the cobas 4800 System and enables laboratories to combine the cobas CT/NG Test and the cobas HPV Test onto a single platform. 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.

About the cobas 4800 System and the cobas HPV Test

The cobas 4800 System is designed to deliver new standards in laboratory testing efficiency and medically relevant diagnostic information. The system offers true walk-away automation and can run up to 282 tests in less than 12 hours, providing rapid analysis of screening tests to meet the needs of the majority of clinical labs.

The cobas HPV Test is the only clinically validated, FDA-approved and CE-marked assay that simultaneously provides pooled results on high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18. Knowing a woman’s status with high-risk HPV genotypes is important as it can provide predictive information about her risk for cervical pre-cancer or cancer.2

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

Roche Molecular Diagnostics received FDA clearance for two new tests on its cobas 4800 PCR detection system. roche cobas z 480 FDA Clears Two STD Tests for the Roche cobas 4800 Diagnostics SystemThe cobas 4800 is a fully automated sample preparation device, which amplifies and detects DNA targets using real-time PCR. The device can run up to 94 tests in 4 hours, enabling rapid analysis of several STD screening tests. 5 different optical channels make it possible to detect multiple targets from one reaction tube. All reagents are easy to load and no thawing or mixing is required. An advanced results algorithm eliminates the need for extra manual curve analysis on the digitally captured data.

The two newly approved tests are used to detect chlamydia trachomatis (CT) and neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self-collected vaginal swabs. The test runs in a multiplex dual probe assay, which means the two targets can be detected in only one sample.

A Human Papilloma Virus (HPV) test already received FDA clearance for the cobas 4800 in April of last year. This test simultaneously provides pooled results on high-risk genotypes like HPV 16 and HPV 18. This makes it possible for laboratories to combine the CT/NG Test and HPV Test onto a single platform.

According to the press release, the registrational trial for the cobas CT/NG test confirmed that self-collected vaginal specimens and male urine specimens provide increased sensitivity and specificity when compared with alternative specimen. The self collection of specimen may help promote the screening compliance for sexually transmitted infections.

Barbara Van der Pol, assistant professor of epidemiology at the Indiana University School of Public Health was cited in the press release:

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.

Source : http://molecular.roche.com/instruments/Pages/cobas4800System.aspx

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