Big Week For HPV Dx: FDA Finalizes Guidance, Task Force Supports Solo Testing
An important task force drafted new recommendations supporting human papillomavirus tests as a solo first-line screen for cervical cancer in some women, followed up by a US FDA final guidance document detailing for test-makers how to best ensure assays for the cervical cancer-causing virus are safe and accurate.
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FDA issued draft guidance on clinical study designs to support PMAs for diagnostics that detect, or detect and differentiate, human papillomaviruses linked to cervical cancer.
CMS took steps to expand coverage for two infectious diseases: a final decision memo to cover screening for human immunodeficiency virus irrespective of risk and a proposal to cover human papillomavirus screens in combination with Pap smears for women aged 30 to 65.
The firm’s cobas human papillomavirus test is the first to gain approved labeling as a primary screen. It could be a market advantage for Roche, but the company now needs to work with clinical guideline developers to put the approved indication into routine practice.