Roche has introduced a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark in order to extend screening options for cervical cancer.
Screening for HPV can help identify individuals at risk of developing cervical cancer.
The solution from Roche allows patients at healthcare facilities to collect the sample needed for HPV screening in private.
The clinically validated vaginal sample is subsequently assessed on a Roche molecular instrument with the Roche cobas HPV test.
This test is indicated for routine cervical cancer screening to analyse cervical precancer and cancer risks according to professional medical guidelines.
The screening includes HPV primary screening, co-testing (or adjunctive screen) with cytology, and triage of women with abnormal cytology.
According to the test performance of the new sampling method, self-obtained vaginal specimens analysed using molecular technology were found to be adequate and offered results that were in line with clinician-collected cervical samples.
Furthermore, the self-sampling solution helped lower barriers by providing patients with an alternative to invasive clinician collection procedures while delivering precise and consistent results, allowing clinicians to make informed patient care decisions.
Roche Diagnostics CEO Thomas Schinecker said: “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.”
Carrying out cervical cancer screening with the cobas HPV test has been clinically established for use on cobas systems in large, Food and Drug Administration (FDA) registrational trials.
Using a single test and 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 Authorization for Roche’s COVID-19 At-Home Test.