DevicePMAs@therightstef:P100020_S000 JSONTXT 11 Projects

Approval for the cobas hpv test. Cobas hpv test indications for use: the cobas hpv test is a qualitative in vitro test for the detection of human papillomavirus (hpv) in patient specimens. The test utilizes amplification of target dna by the polymerase chain reaction (pcr) and nucleic acid hybridization for the detection of 14 high-risk (hr) hpv types in a single analysis. The test specifically identifies types hpv 16 and hpv 18 while concurrently detecting the rest of the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas hpv test is indicated: 1) to screen patients 21 years and older with asc-us (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; and 2) to be used in patients 21 years and older with asc-us cervical cytology results, to assess the presence or absence of high-risk hpv genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; 3) in women 30 years and older, the cobas hpv test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk hpv types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management; and 4) in women 30 years and older, the cobas hpv test can be used to assess the presence or absence of hpv genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management....(see approval order for additional approval statement detail).