Roche Receives FDA Approval for HPV Test
News Jul 09, 2016
Roche has announced that it has received U.S. Food and Drug Administration (FDA) approval for performing the cobas® HPV Test from cervical specimens collected in BD SurePath™ Preservative Fluid using the BD SurePath™ vial. In the U.S., a significant number of cervical cancer screening samples are processed using the SurePath vial and preservative fluid.
The cobas HPV Test is the first HPV (Human Papillomavirus) test approved by the FDA for use with the SurePath collection medium and vial for processing cervical cancer screening samples. The cobas HPV Test, when used with samples collected into SurePath Preservative Fluid, was
demonstrated to be safe and effective for cervical cancer screening.
The test demonstrated comparable performance similar to specimens collected into Thin Prep PreservCyt Solution, another type of cell collection media. The FDA approval of SurePath with the cobas HPV Test includes triage of ASC-US (Atypical Squamous Cells of Undetermined Significance) Pap cytology results and adjunct testing with Pap cytology for women 30 years of age and older. The SurePath Preservative Fluid is not approved for use with the cobas HPV Test as a first-line, primary cervical cancer screening test.
“Until today, no FDA-approved HPV test had been available for laboratories using SurePath Preservative Fluid. We are pleased that the cobas HPV Test is the only test in the United States approved for both the ThinPrep and SurePath collection media”, said Uwe Oberlaender, Head of Roche Molecular Diagnostics, Pleasanton, California.
“Many labs have a preference in how samples are collected for processing, and this additional approval gives them another clinically validated option for the cobas HPV Test.”