Home 5 Clinical Diagnostics Insider 5 Pap Testing Volumes Unlikely to Decline Soon, Even With HPV First-Line Approval

Pap Testing Volumes Unlikely to Decline Soon, Even With HPV First-Line Approval

by | Feb 19, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies

Will the U.S. Food and Drug Administration (FDA’s) recent approval of Roche Molecular System’s cobas HPV (human papillomavirus) test as a first-line, primary screening test for cervical cancer cause Pap (Papanicolaou) test volumes to plummet? Not likely any time soon, according to the experts DTET spoke to. Roche’s cobas HPV, the first FDA-approved HPV DNA test, provides individual detection of HPV 16 and HPV 18, the two most common types of infection, together responsible for about 70 percent of cervical cancer, as well as pooled detection for 12 other high-risk types.  This expanded indication allows for the test to be used instead of Pap testing to screen for cervical cancer in women  25 years old and older. According to the approval, women who test positive for HPV 16 or 18 should have a colposcopy, while women who test positive for one of the other high-risk HPV types should have a Pap test to determine if a colposcopy is needed. This approval conflicts with current professional practice guidelines, which call for the HPV test as a follow-up test for patients aged 21 and older with abnormal cervical cytology and as an adjunct test to Pap in women 30 years and older. […]

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