On May 14, 2024, Roche announced the U.S. Food and Drug Administration (FDA) approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop. HPV self-collection offers an accessible screening option. In a healthcare setting, an individual collects their own vaginal sample, which is sent to a laboratory for analysis with Roche’s cobas® molecular instrument. Those who receive a positive HPV result would then continue their care with a healthcare provider.

More than half the patients diagnosed with cervical cancer in the U.S. have never been screened or have only been screened infrequently, and they do not participate in routine screening. Many factors can contribute to individuals not participating in cervical cancer screening programs, such as access to healthcare, social and economic barriers, history of traumatic experience, cultural concerns and embarrassment. Roche’s self-collection solution can help reduce these barriers by offering an alternative to clinician collection procedures, while also providing accurate and reliable results enabling clinicians to make patient care decisions. 

HPV is the known cause of more than 95% of all cervical cancers.² Roche’s cervical cancer portfolio includes the cobas HPV Test, used for primary screening and co-testing. While the Pap smear can potentially detect abnormalities in the cervix, the cobas HPV test detects 14 types of high-risk HPV genotypes that put patients at higher risk of cervical cancer. It includes results for HPV 16, HPV 18 and 12 other high-risk pooled genotypes.³

The HPV self-collection solution is approved for use with Roche’s cobas HPV test. The cobas HPV test runs on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, which offers 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. The portfolio also includes CINtec PLUS Cytology, the only FDA-approved dual-stain product and CINtec® Histology, the only FDA-cleared p16 biomarker technology that can help pathologists confirm the presence of pre-cancerous cervical lesions.

The IMPACT trial design, used to validate the clinical benefits of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21 percent Black, 24 percent Hispanic-Latino and 0.3 percent American Indian or Alaskan Native participants.⁴ This diversity was critical to accurately assess the performance of dual stain in patient populations with higher incident rates of HPV.