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.
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