TUCSON, Ariz., July 30, 2018 /PRNewswire/ -- Roche (SIX: RO, ROG;OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for the cobas® HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid, a collection medium commonly used for Pap tests. The Roche test is now the only Human Papillomavirus (HPV) test approved for use as a primary (first-line) screening test with both SurePath and ThinPrep PreservCyt Solution, the two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the U.S.
With this FDA decision, the cobas HPV Test is now approved for all of the cervical cancer screening indications that are supported by professional society guidelines—primary screening in women 25 and older, reflex (follow-up) testing of unclear Pap test results in women 21 and older and co-testing with a Pap test in women 30 and older—with both of the primary collection media types.
"Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media," said Ann Costello, Head of Roche Tissue Diagnostics. "With this additional approval for the cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types, so they can more easily provide the most appropriate options for their patients."
The cobas HPV Test, introduced in 2011, helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18—the two genotypes responsible for about 70 percent of all cervical cancer—and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening (without an accompanying Pap test) for the cobas HPV Test in 2014. More information about the cobas HPV Test is available at: https://www.hpv16and18.com/index.html
About cobas HPV Test and cobas 4800 System
The cobas HPV Test, clinically validated by the landmark ATHENA study, is approved in the U.S. for use with 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.
In addition to the cobas HPV Test, the cobas 4800 system test menu includes 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 4800 system and its test menu is available at http://molecular.roche.com.
About Human Papillomavirus and cervical cancer
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. HPV testing is used in cervical cancer screening protocols to identify women at risk for developing cervical pre-cancer and cancer.
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 that there are more than 500,000 new cases of cervical cancer annually.
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*Not all products and uses are available in all countries. Please refer to the package insert for applicable intended uses for each individual product.
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Todd Siesky, Roche Molecular Solutions