Communications Business Partner
Roche Diagnostics Corporation
Pleasanton, July 7, 2016
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 ThinPrep 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.”
Clinically validated by the landmark ATHENA trial, the cobas HPV Test provides specific genotyping information for HPV 16 and HPV 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one test and from one patient sample.
The cobas HPV Test is performed on the cobas 4800 System, which offers walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real- time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs Roche tests for CT/NG (chlamydia/gonorrhea), HSV 1 and 2 (Herpes Simplex Virus), MRSA/SA (methicillin-resistant Staphylococcus aureus and Staphylococcus aureus) and C. difficile, as well as BRAF, EGFR and KRAS mutations. More information about the cobas HPV Test is available at www.hpv16and18.com.
Persistent infection with high-risk Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. According to the National Cancer Institute, there are more than 12,000 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually.
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