According to the American Cancer Society, cervical cancer is one of the most successfully treatable cancers if detected early. Cervical cancer can sometimes be found early and even prevented entirely by having regular Pap tests, which examine cervical cells for changes indicative of cervical cancer. However, studies show that Pap cytology can have high false-negative rates. More than 10,000 women in the United States continue to be affected by this cancer every year, even with the advent of liquid cytology and human papillomavirus (HPV) tests approved by the FDA in 2003. The latest cervical cancer screening guidelines recommend two options
- Cytology for women ages 30-65
- Co-testing which is human papillomavirus (HPV) testing along with cytology
FDA approval for Roche Molecular Systems’ cobas HPV Test for primary cervical cancer screening in women age 25 years or older offers women and physicians a third efficient option.
The Cobas HPV Test
Roche Diagnostics won initial FDA approval for the cobas HPV Test in 2011. The test was approved for use in combination with or as a follow-up to a Pap test. In April 2014, the FDA’s approval expanded the use of the test to include use as either a co-test or as a primary cervical cancer screening test. The approval of the test was based on the results of a well-designed study that Roche Diagnostics conducted, which provided the FDA with a reasonable proof of its safety and effectiveness when used as a primary screening tool for cervical cancer.
HPV infections are responsible for almost all cervical cancers, with two types, HPV 16 and HPV 18 causing about 70 percent of cervical cancers. Roche’s 3-year study – the ATHENA (Addressing THE Need for Advanced HPV Diagnostics) trial – covered more than 47,000 women older than age 25 undergoing routine cervical exams. It evaluated the performance of cobas as a first-line screening test along with a new algorithm that simultaneously identifies DNA from HPV types 16 and 18 and provides pooled results for 12 other high-risk HPV types commonly associated with cervical cancer.
Women who tested positive in a Pap test or whose screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV test results. The results, which included three years of follow-up on women who had colposcopy, showed that the cobas HPV Test is safe and effective as a primary screening test for cervical cancer.
Primary HPV Screening at the Center Stage
According to a new report published in aacc.org, recently published ATHENA data show HPV primary testing results are less variable than cytology findings from four laboratories that tested the same samples. The report points out that, at present, cervical screening guidelines do not recommend primary HPV screening, because they were published before any FDA-approved test was available for this, and also because experts needed more evidence to support primary HPV screening.
Now that the FDA has approved the cobas HPV test as an efficient option for primary cervical cancer screening, clinicians need to need to be educated on its proper use including the new algorithm and how it attains specificity, and various HPV tests performance characteristics. The author of the AACC report says that this is where clinical laboratories can assist physicians by helping them choose the appropriate screening method and ensure compliance with guidelines.