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USFDA gives nod to Roche’s self-testing kit for cervical cancer in United States – Healthcare News



Swiss drugmaker Roche on Wednesday announced that the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-testing kit. Screening for HPV can help identify women who are at risk of developing cervical cancer at an earlier stage.

Roche claims that it is one of the first available in the United States.

“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,” the company said in a statement.

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“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, CEO of Roche Diagnostics. “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.”

More than half the patients diagnosed with cervical cancer in the United States have never been screened or have only been screened infrequently, and they do not participate in routine screening. According to the World Health Organization (WHO), almost all cervical cancer cases (99 percent) are linked to infection with high-risk human papillomaviruses (HPV), an extremely common virus transmitted through sexual contact.

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, it claimed.

Moreover, the company has collaborated with the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), on the Cervical Cancer “Last Mile” Initiative. This public-private partnership has, in part, facilitated the regulatory pathway towards the approval, it added.

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