Roche’s HPV self-collection test wins FDA approval

SWITZERLAND – Roche, a Swiss health technology company, has earned FDA approval for its new HPV self-collection test, designed to improve access to cervical cancer screening in the United States.

This self-collection solution is compatible with the company’s cobas HPV test, which operates on the cobas 4800 and the high-throughput cobas 5800, 6800, and 8800 systems.

These platforms offer scalable testing: the cobas 5800 delivers up to 96 results in three hours, while the 6800 and 8800 systems generate 384 and 1,056 results, respectively, within a typical eight-hour workday.

The test also integrates with Roche’s FDA-approved dual-stain CINtec PLUS Cytology and CINtec Histology — the only p16 biomarker test approved for use in the U.S., enhancing diagnostic accuracy.

Roche’s self-collection test is among the first of its kind available in the country. It allows individuals to collect their own vaginal sample in a healthcare setting, which is then processed in a lab.

Those with a positive HPV result are referred to a healthcare provider for follow-up care.

“By combining self-collection with powerful diagnostic tools, we’re helping reduce barriers to screening,” said Matt Sause, CEO of Roche Diagnostics. “This brings us closer to the WHO’s goal of eliminating cervical cancer by 2030.”

According to Roche, more than half of women diagnosed with cervical cancer in the U.S. have either never been screened or are screened too infrequently.

HPV screening can help detect those at risk before the disease develops, enabling timely treatment.

This FDA approval was partially made possible through Roche’s collaboration with the National Cancer Institute (NCI), part of the NIH’s ‘Last Mile’ Initiative – a public-private partnership focused on eliminating cervical cancer.