PLEASANTON, Calif./PRNewswire/ — Roche 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.
Posted by Sean Fenske, Editor-in-Chief, MDT
