Swiss healthcare company Roche announced the rollout of a new human papillomavirus (HPV) self-sampling solution across countries that accept CE mark.
The new HPV solution requires a patient to privately collect her vaginal sample while at a healthcare facility, as instructed by a healthcare worker.
The clinically-validated vaginal sample is analysed using the Roche cobas HPV test on a Roche molecular instrument.
The cobas HPV test is indicated for use for routine cervical cancer screening pursuant to professional medical guidelines.
It facilitates HPV primary screening, co-testing with cytology, and for triage of women with abnormal cytology to determine the risk for cervical precancer and cancer.
Under the new sampling method, the self-collected vaginal specimens are tested using a molecular technology, providing results that are comparable to clinician-collected cervical samples, said Roche.
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.”
According to the company, women in low- and middle-income countries are often diagnosed with cervical cancer at a more advanced stage, where chances for therapy are limited.
Screening for HPV can help identify women who are at risk of developing cervical cancer, enabling early detection and treatment of the disease before it progresses.
Roche claimed that its self-sampling solution will provide women with an alternative to more invasive clinician collection procedures, along with accurate and reliable results.
Also, cervical cancer screening using its cobas HPV test was clinically validated in large, US FDA registrational trials for use on cobas systems
The assay individually identifies the DNA of HPV genotypes 16 and 18, the two genotypes prevalent in almost 70% of all cervical cancers.
Using a single patient sample, the assay provides a combined result that also includes 12 other high-risk HPV types.
