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Roche Wins the First HPV Primary Screening Tender in Europe
First Tender Awarded for the National Cervical Cancer Screening Program in the Netherlands
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has been awarded a 5-year contract by the National Institute for Public Health and the Environment (RIVM) in the Netherland for implementation of the cobas® HPV Test as the first-line, primary screening test in the national cervical cancer screening program. The decision concludes an extensive public tender process in which diagnostic providers were assessed on their ability to meet performance, quality and pricing criteria. The new national HPV based screening program is expected to start in the second half of 2016.
The Netherlands is expected to be the first country in the world with an organized cervical screening program to fully transition from the Pap test to primary HPV screening. Using HPV as the primary test is based on the overwhelming scientific evidence that it offers significant improvement over more traditional Pap cytology screening due to its ability to detect more pre-cancerous disease.
“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.” said Dr. R.L.M. Bekkers, Gynecologist/Gynecologic Oncologist, Radboud University Medical Centre. Nijmegen. “Selecting the appropriate HPV test is a crucial first step for the success of this program.”
The new Dutch cervical screening program with HPV includes a longer interval between routine screening visits as well as an option for women to self-collect their screening samples. To meet the needs of these program requirements, only HPV tests that utilize DNA PCR-based technology were considered for the tender.
“The cobas HPV Test was selected by the RIVM because it is supported by all the necessary evidence and data”, said Roland Diggelmann, Chief Operating Officer of Roche Diagnostics. “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.”
About the cobas HPV Test and cobas 4800 System from Roche Molecular Systems
Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample. In April 2014, the FDA approved the cobas® HPV Test as a first-line primary screening test for cervical cancer in women 25 and older. It is now the only assay approved for the following indications: ASC- US reflex, co-testing, and primary screening.
The test is performed on the cobas 4800 System, which offers true 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 system also runs the cobas 4800 CT/NG Test (chlamydia/gonorrhea), cobas Cdiff Test, cobas MRSA/SA Test, cobas HSV1 and 2 Test, and the cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test and cobas KRAS Mutation Test.
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