The Cobas HPV test from Roche Molecular Diagnostics, Pleasanton, Calif, has received FDA clearance for use as a first-line primary screening test for cervical cancer in women 25 and older. The qualitative multiplex assay detects 14 high-risk HPV types while providing specific genotyping information for HPV types 16 and 18, the types responsible for about 70% of cervical cancer. The test is automated for the Cobas 4800 system, which provides walk-away automation of nucleic acid purification, polymerase chain reaction (PCR) set-up, and real-time PCR amplification and detection to facilitate laboratory efficiency. The automated result algorithm provides clear positive, negative, or invalid results. For more information, visit Roche Molecular Diagnostics.
First HPV Test Cleared for Cervical Cancer Primary Screening
