On April 20, 2011 Roche Diagnostics announced the United States Food and Drug Administration approved of its new HPV test, cobas. This new test detects the presence of DNA for 14 high risk strains of the virus. There are a few differences however between cobas and the other HPV tests currently on the market.
Roche’s test will check for 14 of the high risk HPV strains. The Hologic test, Cervista, also tests for these same 14 strains, while the digene test checks for 13.
Once this is completed, the Roche test will then concurrently genotype the specimen for HPV types 16 and 18. These two HPV strains are shown to cause approximately 70 percent of all cervical cancers.
The ATHENA study was utilized to determine the effectiveness of this new cobas test. The study was conducted throughout the United States and involved a total of 47,000 women. It showed that one in 10 women who tested positive for types 16 and 18 genotyping had precancerous lesions despite having a negative result on their Pap smears.
Roche representatives Christoph Majewski , Head of HPV molecular science and Dr. Catherine Behrens, Director of Medical Affairs, stated that of the women involved in the ATHENA study with a Pap result of ASCUS (atypical squamous cells of undetermined significance), 90 percent were shown on biopsy to have CIN2/3 lesions. Of those, 46 percent were CIN3.
The National Cancer Institute indicated that 10 percent of women who are positive for HPV types 16 and 18 have been shown to develop CIN3 (cervical intraepithelial neoplasia grade 3) within three years. CIN3/CIS (carcinoma in situ) is the most severe type of abnormality prior to the lesion becoming an invasive cancer.
The current digene HPV test in existence for over ten years does not, at this point, genotype within its 13 panel assay. It has, however, since its inception performed over 40 million tests and had over 300 peer review articles with respect to its methods. Both Hologic and Roche has a bit of catching up to do in that respect.