The landmark IMPACT (IMproving Primary screening And Colposcopy Triage) trial is a cervical cancer screening study designed to clinically validate and support the FDA approval of multiple products, including CINtec® PLUS Cytology, a dual-stain biomarker-based test, and the cobas® HPV test for use on the cobas® 6800/8800 Systems.
CINtec® PLUS Cytology received its first FDA approval in March 2020 to be used as a triage test for women who are positive for high-risk HPV. This dual-stain test looks for the simultaneous presence p16 and Ki-67 within a single cell. The co-expression of these two biomarkers is associated with HPV infections that have started the oncogenic transformation process towards pre-cancer or cancer. A positive CINtec® PLUS Cytology result signals that a woman is more significantly at risk for disease, and could benefit from immediate follow-up. A negative CINtec® PLUS Cytology result means there are no signs of oncogenic transformation, and a woman can be given more time for her body's immune system to clear the HPV infection.
Based on IMPACT trial results, in April 2020 the FDA also approved the cobas® HPV test for use on the cobas 6800/8800 Systems. Previously, in 2011 the cobas® HPV test had been FDA approved for use on only the cobas 4800 System. The cobas® HPV test is approved for primary HPV screening in women 25 and older, as a reflex (follow-up) test for ASC-US (Atypical Squamous Cells of Undetermined Significance) Pap cytology results in women 21 and older, and as a co-test with Pap cytology for women 30 and older using ThinPrep® PreservCyt® Solution.†
While most HPV infections resolve on their own, some women who test positive for high-risk HPV, or whose co-testing results are possibly discrepant - HPV positive and Pap cytology negative - may develop pre-cancerous cervical lesions that, if left untreated, could progress to cervical cancer. Early identification of women who are most at risk is vital. Based on our understanding of the science behind HPV, we know that more advanced technology options can improve the status quo.
Facts and Figures
• Multi-center, prospective trial
• Enrolled close to 35,000 women at 32 collection sites across the US
• Representative of routine cervical cancer screening population in the US:
• Age 25-65
• Non-vaccinated & vaccinated
• Diverse races & ethnicities
• More than 5,000 HPV(+) subjects
• 595 ≥CIN2 disease cases found
Trial data will be broadly shared, pending publication of the key findings.
† THINPREP and PRESERVCYT are trademarks of Hologic, Inc. Reference to these marks does not imply approval or endorsement of any Roche products by Hologic, Inc.