Roche announced the recent U.S. Food and Drug Administration (FDA) approval of the cobas HPV test for use on its next-generation cobas 5800 molecular instrument.
The cobas HPV test is indicated for use for routine cervical-cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer. The cobas 5800 supports loading primary-collection vials directly onto the compact system, minimizing hands-on time.