Roche has introduced a solution for human papillomavirus (HPV) self-sampling in countries accepting CE marking to expand cervical cancer screening capabilities.
Screening for HPV can help identify individuals at risk of developing cervical cancer.
Roche’s solution allows patients in healthcare facilities to privately collect the sample needed for HPV screening.
The clinically validated vaginal sample is then assessed on a Roche molecular instrument with the Roche cobas HPV test.
This test is indicated for routine cervical cancer screening to analyze cervical cancer and cancer risk according to professional medical guidelines.
The screening includes primary HPV screening, co-testing (or additional screening) with cytology, and triage of women with abnormal cytology.
According to the test performance of the new sampling method, self-obtained vaginal specimens analyzed using molecular technology were found to be adequate and to yield results consistent with cervical specimens collected by clinicians.
In addition, the self-collection solution helped lower barriers by providing patients with an alternative to invasive clinician collection procedures while delivering accurate and consistent results, enabling clinicians to make informed decisions about patient care.
Thomas Schinecker, CEO of Roche Diagnostics: “Cervical cancer elimination is within reach.
“Reducing barriers to HPV screening by allowing women to self-collect their own specimens for HPV testing is a critical tool in the fight against cervical cancer.”
Performing cervical cancer screening with the cobas HPV test has been clinically established for use on cobas systems in large Food and Drug Administration (FDA) registration studies.
Using a single test and a patient sample, the assay can detect the presence of the deoxyribonucleic acid (DNA) of HPV genotypes 16 and 18, which is reported as a combined result with 12 additional high-risk HPV types.
Nearly 70% of all cervical cancers are caused by HPV genotypes 16 and 18.
Last December, the US FDA granted emergency use approval for Roche’s COVID-19 Home test†