Roche Receives FDA Clearance for Test to Screen and Diagnose Chlamydia and Gonorrhea Infection in Symptomatic and Asymptomatic Patients

Roche (OTC: 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 and Neisseria gonorrhoeae infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs. A polymerase chain reaction-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."