The National Institute for Public Health and the Environment (RIVM), Netherlands, has granted Roche a five-year contract to implement the first-line, primary screening test in the national cervical cancer screening program. The screening exam is called cobas HPV Test and is being included in Netherlands’ national program after an extensive public tender process and evaluation of the test’s ability to meet performance, quality and pricing criteria.
The Netherlands are planning to initiate the new national HPV screening program during the second half of 2016, making it the first country worldwide to completely transition from the Pap test to primary HPV screening in an organized cervical screening program. Scientific research backs the use of the HPV test due to the its capacity to detect more pre-cancerous diseases and its significant superiority compared to traditional Pap cytology screening. “The movement towards a national HPV screening program will lead to a more efficient and effective use of resources and, most importantly, fewer women will develop cervical cancer,” explained Dr. R.L.M. Bekkers, who serves as Gynecologist/Gynecologic Oncologist at the Radboud University Medical Centre in Nijmegen, Netherlands, in a press release. “Selecting the appropriate HPV test is a crucial first step for the success of this program.”
In the new screening program, women won’t need to be submitted to routine screening visits with such regularity, and patients will be able to self-collect their screening samples. “We believe countries around the world will be looking toward the Netherlands as a potential model for how to best implement HPV primary screening to prevent cervical cancer. We are excited to have been chosen as their partner,” added Roland Diggelmann, Chief Operating Officer of Roche Diagnostics.
To achieve the program requirements, the Dutch institute only considered HPV tests that use DNA PCR-based technology. “The cobas HPV Test was selected by the RIVM because it is supported by all the necessary evidence and data”, added Diggelmann. Roche’s test is performed on the cobas 4800 System, which delivers walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up, and real-time PCR amplification and detection to help laboratories achieve maximum efficiency.
The cobas HPV test was scientifically studied in the ATHENA trial and is currently the only HPV assay approved by the U.S. Food and Drug Administration (FDA) that offers specific genotyping information for HPV 16 and 18, the two HPV subtypes with highest risk. In addition, the exam can also report 12 other high-risk HPV types as a pooled result. The FDA approved Roche’s test in April 2014 as a first-line primary screening test for cervical cancer in women 25 and older, and it is now approved for ASCUS reflex and co-testing.