Roche has announced the launch of a human papillomavirus (HPV) self-sampling solution in countries accepting the CE mark, expanding access to HPV screening options by enabling patients to privately collect their sample while at a healthcare facility.
Every year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, with persistent infection with specific types of HPV accounting for nearly all cases.
Screening for HPV can help identify women who are at risk of developing cervical cancer as it rarely causes overt symptoms in its early stages, however there are many factors that contribute to women not participating in screening programmes, including limited access to testing, past experiences and cultural influences, Roche outlined.
Moreover, in low- and middle-income countries, women are often diagnosed with cervical cancer at a more advanced stage.
The company hopes its self-sampling solution will help reduce these barriers by offering women an alternative to more invasive clinician collection procedures and enabling screening in additional healthcare environments, while also providing ‘accurate and reliable results’ to enable clinicians to make patient care decisions.
Roche’s 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 screening) 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 demonstrated that self-collected vaginal specimens tested using a molecular technology are ‘fully adequate’, Roche outlined, and provide results that are ‘comparable to clinician-collected cervical samples’.
Jonathan Keytel, head of healthcare transformation at Roche Diagnostics, said: “Self-sampling technology is poised to transform cervical cancer prevention. In Africa, many barriers still exist for women in need of HPV screening. Underdeveloped nations carry the highest burden of cervical cancer, but access to adequate treatment can be challenging.
“We hope to break down these barriers and address the prevalence of cervical cancer on a wider scale by enabling women to collect their own specimens.”
The launch falls in line with the World Health Organization’s (WHO) global strategy to eliminate cervical cancer, adopted in August 2020.
Specifically, these targets include fully vaccinating 90% of girls with the human papillomavirus (HPV) vaccine by age 15, screening 70% of women using a high-performance test by age 35, and again by 45, as well as ensuring 90% of women identified with cervical disease receive treatment.