cobas ® HPV Test - Roche Diagnostics USA
The cobas ® HPV tests are automated qualitative in vitro tests for the detection of human papillomavirus (HPV) DNA in patient specimens. The tests utilize amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk HPV (hrHPV) types in a single analysis.
cobas® HPV, Qualitative nucleic acid test for use on the cobas® …
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79 The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus (HPV) in patient specimens. The test utilizes 80 amplification of target DNA by the...
The FDA-approved cobas® HPV test, the first step in the Roche Cervical Cancer Portfolio, objectively identifies women at risk and improves detection of high-grade disease in a single round of screening, utilizing molecular
Compare all HPV tests approved in the US | BD Onclarity HPV Assay
Only the BD Onclarity™ HPV Assay provides you with the most comprehensive HPV test results available on the market today. Get the information you need to more precisely assess her risk of cervical cancer.
Apr 25, 2014 · Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) approved the cobas HPV (Human Papillomavirus) Test for use as a first-line primary screening test for cervical cancer in women 25 and older.
FDA Approves Self-Collection cobas HPV Test for Early Detection …
May 20, 2024 · The cobas HPV test is an automated qualitative in vitro test for the detection of HPV DNA in patient specimens. In a single analysis, the test utilizes amplification of target DNA through a polymerase chain reaction (PCR) and nucleic acid hybridization to detect 14 high-risk HPV (hrHPV) types.
FDA Approves cobas HPV Test for Measurement of Cervical …
Apr 21, 2020 · The FDA has granted approval for the cobas high-risk human papillomavirus (HPV) test, which identifies women at risk for developing cervical cancer by exposing the presence of high-risk HPV DNA in cervical samples.
Clinical validation of the Roche cobas HPV test on the Roche cobas …
Sep 11, 2024 · This study assessed the relative clinical sensitivity and specificity, as well as reproducibility, for high-risk HPV types of the Roche cobas HPV test when processed using the Roche cobas 5800 system.
Roche’s HPV Test Gains WHO Prequalification: A Step Forward in …
Oct 22, 2024 · Roche’s cobas® HPV test receiving WHO pre-qualification is a critical step in the global fight to eliminate cervical cancer. By expanding access to high-quality screening tools, especially in regions that need them most, this development helps pave the …