The US Food and Drug Administration (FDA) has granted 510(k) approval for Roche's cobas Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG ) test.
The test is a polymerase chain reaction (PCR)-based multiplex dual probe assay, running on the company’s automated cobas 4800 System, used to detect CT and NG infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs.
The cobas 4800 System can run up to 282 tests in less than 12 hours and delivers new standards in laboratory testing efficiency and medically relevant diagnostic information.
Roche said the registrational trial for the cobas CT/NG test showed 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.
Roche’s cobas CT/NG test has also received CE mark in 2009.