About the cobas HPV Test and cobas 4800 System from Roche Molecular Systems

Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample. In April 2014, the FDA approved the cobas® HPV Test as a first-line primary screening test for cervical cancer in women 25 and older. It is now the only assay approved for the following indications: ASC- US reflex, co-testing, and primary screening.

The test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas 4800 CT/NG Test (chlamydia/gonorrhea), cobas Cdiff Test, cobas MRSA/SA Test, cobas HSV1 and 2 Test, and the cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test and cobas KRAS Mutation Test.