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FDA panel backs Roche's HPV assay as first-line cervical cancer screen

This article was originally published in Clinica

Executive Summary

The US FDA’s Microbiology Devices Panel has unanimously backed Roche’s cobas HPV test to be marketed as a first-line cervical cancer screening test, meaning it could replace the current standard, Pap smear testing. But, assuming FDA follows the panel’s recommendations, national clinical guidelines will likely need to catch up as well. The US Preventative Services Task Force does not currently recommend first-line cervical cancer screening with HPV assays. It also “recommends against screening for cervical cancer with HPV testing, alone or in combination with cytology, in women younger than age 30 years.” The panel voted 13-0 that Roche’s assay was safe, effective and the benefits outweighed the risks. The test is already CE marked in Europe for first-line screening. In the US, HPV tests are only approved for use in conjunction with Pap.

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