FDA approves first HPV test for primary cervical cancer screening

FDA approved Roche's HPV test 24th April in accordance with the recommendation of the FDA advisory committee. “Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

Link to FDA's news release: