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Roche gets FDA approval for HPV self-collection solutions

Roche said providing women with a self-collection option will improve their access to testing.
Credit: Roche

INDIANAPOLIS — On Wednesday, Roche announced it had obtained approval from the U.S. Food and Drug Administration for its human papillomavirus self-collection solution, calling it "one of the first available in the United States."

The company said screening for HPV can help identify women at risk of developing cervical cancer so the disease can be found and patients can receive early treatment.

“With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, Roche Diagnostics CEO. “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.”

In a media release, Roche said "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."

The company hopes the self-collection solution will reduce barriers to treatment while providing accurate results to help make patient care decisions. 

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