QIAGEN N.V. expanded its Canadian class 3 medical device license for its HPV test platform to include screening for cervical cancer, with or without the Pap test, enabling primary, front-line HPV screening in Canada. Human papillomavirus (HPV) is the primary cause of cervical cancer. HPV testing identifies women with high-risk HPV infections that can cause cervical cancer, enabling diagnosis and treatment to be put in place before cervical cancer develops.
As part of front-line HPV screening of women age 30 and older, women may be initially screened for the types of high-risk HPV that can cause cervical cancer, and women with positive HPV test results receive a follow-up Pap test (“Pap triage”) to determine if abnormal or precancerous cells are present. QIAGEN’s digene hc2 High-Risk HPV DNA Test (also known as “the digene HPV test”) is also licensed in Canada for cervical cancer screening together with the Pap test (“co-testing”) for women age 30 and older, as well as to screen patients of any age with ASC-US (atypical squamous cells of undetermined significance) Pap results to assess the need for referral to colposcopy.
The label expansion also includes running the digene HPV Test from BD SurePath specimens. “The digene HC2 High-Risk HPV DNA Test when used adjunctively with the BD SurePath Pap Test demonstrates acceptable performance in the detection of CIN2+ and CIN3+ disease and the ruling out of disease in cases where none is present…BD SurePath Preservative Fluid is an appropriate alternative collection and transport medium for gynecologic specimens tested with the digene HC2 High-Risk HPV DNA Test,” the updated package insert now reads. With this update, co-testing with the digene HPV Test can be performed by laboratories on three different specimen collection vials: BD SurePath, Hologic PreservCty (“ThinPrep” Pap) and QIAGEN’s proprietary sample collection device, the digene Specimen Transport Medium (STM).
“Consistent data obtained from multiple cross-sectional and prospective cohort studies conducted with a variety of cell sampling methods and utilizing the digene HC2 High-Risk HPV DNA Test provide strong evidence that a negative HPV DNA test result implies very low risk of prevalent or incipient CIN 2-3 or cancer when Pap results are normal (NILM),” new language in the updated package insert states, specifically referencing data from the Canadian Cervical Cancer Screening Trial (CCCaST) and the New Technologies for Cervical Cancer (NTCC) Study. “Each study is cited in the 2009 American College of Obstetricians and Gynecologists (ACOG) Guidelines in support of adjunctive HPV testing with cytology in women 30 years and older; each study is listed as Level I evidence.”
“With this licensure from Health Canada, the digene HPV Test can now be run off a broader range of specimens if healthcare providers are co-testing with HPV and Pap together. Particularly exciting about this label update, however, is the ability for Canadian healthcare providers to now adopt HPV testing as a front-line screen, using HPV detection as a primary screening test to identify those women with HPV infections who are at greater risk for advanced cervical disease or cancer,” said Ronald Kolojek, QIAGEN’s Area Business Director–Canada.
The digene HPV test is now licensed in Canada and Europe for front-line primary screening, for co-testing together with the Pap and for ASCUS-reflex testing. In the U.S., the test is approved only for co-testing and ASCUS reflex.