Pleasanton, CA 24 April 2014
On April 24, 2014, Roche Molecular Diagnostics received word from the U.S. Food and Drug Administration (FDA) that they have approved our cobas® HPV Test as a first-line, primary screening tool to help identify women ages 25 and older who have an increased risk of cervical cancer. This comes following the March 12 Medical Devices Advisory Committee Meeting, where experts voted that there was substantial evidence to recommend the cobas® HPV Test be approved for an expanded, primary screening indication.
The FDA decision is a momentous event, as it recognizes the medical value of our landmark ATHENA trial, and gives physicians in the U.S. the ability to make more informed decisions that might help prevent women from developing cervical cancer. First-line, primary screening with the cobas® HPV Test offers the potential for a new paradigm to improve women’s health.
For RMD, the new approval even better positions us in the market, as we can now offer the first and only HPV test FDA approved for first line, primary screening. Moving forward, we are committed to working with the professional organizations to help put in place new medical practice guidance documents so that patient care standards will be updated accordingly.
We are proud of our role in advancing Women’s Health, and we look forward to much success as a result of this new development. Thank you for your continued dedication and work to keep us at the the forefront!