Launch in countries accepting the CE Mark of human papillomavirus (HPV) self-sampling solution, expanding cervical cancer screening options.
Roche announced the launch of a human papillomavirus (HPV) self sampling solution in countries accepting the CE mark.
This new solution enables a patient to privately collect her sample for HPV screening while at a healthcare facility, following instructions provided by a healthcare worker.
The clinically-validated vaginal sample is analysed with the Roche cobas HPV test on a Roche molecular instrument. Screening for human papillomavirus (HPV) can help identify women who are at risk of developing cervical cancer, so that the disease can be found and treated early before it has a chance to develop. There are many drivers that contribute to women not participating in cervical cancer screening programs, including limited access to testing, past experiences, embarrassment and cultural influences. Roche’s self sampling solution helps reduce these barriers by offering women an alternative to more invasive clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions.
“The elimination of cervical cancer is within reach. Reducing barriers to HPV screening by enabling women to self-collect their own specimen for HPV testing is a critical tool in the fight against cervical cancer,” said Thomas Schinecker, CEO Roche Diagnostics.
In low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage, where the opportunity for cure is low. By broadening access through removing barriers and enabling screening in additional healthcare environments, Roche highlights its commitment to achieving the World Health Organisation’s global strategy to eliminate cervical cancer and reduce the overall mortality rate.
About the cobas HPV test: The cobas HPV test is indicated for use for routine cervical cancer screening as per professional medical guidelines, including HPV primary screening, co-testing (or adjunctive screen) with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer. Test performance for this new sampling method demonstrates that self-collected vaginal specimens tested using a molecular technology are fully adequate, and provide results that are comparable to clinician-collected cervical samples.
Cervical cancer screening using the cobas HPV test is clinically validated in large, FDA registrational trials for use on cobas systems, and the assay individually identifies the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample.
The fully automated cobas 6800/8800 Systems offer the fastest time to results, providing up to 96 results in about three hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an eight hour shift.
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