Roche secures FDA approval for its HPV self-collection solution

Roche’s human papillomavirus (HPV) self-collection solution, intended for use with cobas HPV test, which runs on its cobas 4800 and the fully automated cobas 5800/6800/8800 systems, provides an accessible screening option for womenSwiss health technology company Roche has received the US Food and Drug Administration (FDA) approval for its human papillomavirus (HPV) self-collection solution. The HPV self-collection solution is intended for use with the company’s cobas HPV test, which runs on its cobas 4800 and the fully automated cobas 5800/6800/8800 systems. The cobas 5800 system provides up to 96 results in about three hours, the cobas 6800 System 384 results and the cobas 8800 System offers 1,056 results in an eight-hour shift. The test can also be used with CINtec PLUS Cytology, the only FDA-approved dual-stain product and CINtec Histology, the only FDA-approved p16 biomarker technology. Roche said that its HPV self-collection solution, which offers an accessible screening option, is one of the first such products available in the US. Roche Diagnostics CEO Matt Sause said: “With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach. “Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.” According to the company, more than half the US patients diagnosed with cervical cancer have never been screened or screened infrequently, and they do not undergo routine screening. Screening for HPV is said to help identify women at risk of developing cervical cancer, enabling early diagnosis and treatment before the disease progresses. Roche said that its self-collection solution helps reduce the barriers to screening by providing an alternative to clinician collection procedures, while offering accurate results. HPV self-collection allows an individual to collect their vaginal sample in a healthcare setting, which is then sent to a laboratory for analysis. People who receive a positive HPV result would continue their care with a healthcare provider. Roche has collaborated with the National Cancer Institute (NCI), a part of the National Institutes of Health (NIH)’s ‘Last Mile’ Initiative on cervical cancer. Its public-private partnership with NIH has partly facilitated the regulatory pathway towards the approval, said the Swiss health technology company.