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September 24, 2020

Roche Gets Expanded Use Approval from FDA for Cervical Cancer Test

The FDA has approved the expanded use of an assay for women who undergo cervical cancer screening and test positive for high-risk types of human papillomavirus (HPV). This development might be a crucial breakthrough considering that amongst dozens of types of HPV, 14 are considered high risk for causing cancer, including cervical cancer. A screen of HPV DNA could help identify the women at risk for cervical cancer, and thus could help support clinical decisions regarding the benefits of immediate follow-up. Researchers have suggested that this test will help define a woman’s risk of disease, reduce the potential for suboptimal treatment, and is a major step in individualizing a woman’s care.” It can take 10 to 15 years or  for cervical cancer to develop, so knowing a woman’s individual risk is an important early prevention strategy to avoiding cancer development. The WHO estimates that there are close to 570,000 new cases of cervical cancer annually, and 311,000 related deaths.