Cytopathology and More | ATHENA design, data—and the FDA’s decision
August 2014—The Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory Committee held a hearing March 12 on a proposal by Roche Molecular Systems for a new application of human papillomavirus first-line primary cervical cancer screening for women age 25 and older. The 13-member panel unanimously approved the test as safe and effective with benefits to women’s health. The FDA formally approved the additional testing indication on April 24.