NEW YORK (GenomeWeb) – Roche said today that it has received the CE IVD mark for its Cobas HPV assay on the Cobas 6800/8800 systems for cervical cancer screening.
Cobas HPV is a real-time PCR test that provides specific genotyping information for human papillomavirus 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result.
As demonstrated by the prospective clinical study ATHENA comparing screening strategies using Cobas HPV on the Cobas 4800 system, screening with the human papillomavirus test detects more high-grade disease than a Pap test alone.
Based on the results of that trial, in 2012 Roche received CE IVD marking for the test running on the Cobas 4800 as a primary screen for cervical cancer, and in 2014 received US Food and Drug Administration approval for the same indication after a unanimous recommendation from an FDA advisory panel.
The newest CE mark is for the assay on the fully automated Cobas 6800/8800 systems, which also allow laboratories to run CE marked Cobas assays for chlamydia/gonorrhea, HIV-1, hepatitis C virus, hepatitis B virus, and cytomegalovirus; as well as three donor screening tests: Cobas MPX, WNV, and HEV.
According to Roche, the Cobas 6800/8800 systems help laboratories meet the throughput needed by high-volume, HPV DNA screening programs by providing up to 96 results in less than 3.5 hours, and a total of 384 results for the Cobas 6800 and 960 results for the Cobas 8800 in an eight-hour shift. Both platforms make it possible for labs to perform up to three tests in the same run with no pre-sorting required, Roche said.
"In addition to the powerful clinical benefits of the Cobas HPV test, Roche now caters to the needs of both low- to mid-volume labs and high-throughput labs who want to consolidate a multitude of validated assays onto a single platform," Roche Diagnostics CEO Roland Diggelmann said in a statement.