What do new ASCCP recommendations mean for dual-stain technology?

 

Inclusion of guidelines on dual stain expected to help clinicians triage people with high-risk HPV.

May __, 2024

 

The American Society of Colposcopy and Cervical Pathology, also known as ASCCP, took a historic step in March 2024 by including a new technology to triage women and people with a cervix who are positive for the types of HPV that have higher risks of developing cervical cancer.

 

What’s different about ASCCP guidelines and why does it matter for cervical cancer?

The ASCCP cervical cancer management guidelines now recognize dual-stain technology as an option in managing patients in both the HPV primary and co-testing screening pathways. Dual-stain cytology can detect the tumor-suppressor protein p16 and cell proliferation marker Ki-67 in women with positive HPV results. The co-expression of these two biomarkers within the same cell is a strong indicator that an HPV infection is evolving into pre-cancer. This means that dual stain can reduce the time to detect cervical pre-cancer. 

 

Why are these guidelines important?

Managing patients becomes more complex each year, as we learn more about HPV and other risk factors and new technology emerges to help triage those risks. The ASCCP guidelines provide clinicians with a consistent path that provides better insight and recommendations in how to manage their patients. It also maintains a widely used app that provides clinicians with an easier way to make determinations for patients. A pathway to using dual-stain technology is expected to be included in the near future.

 

What do the guidelines say about dual stain?

The guidelines specifically state that dual stain is a robust marker of cervical intraepithelial neoplasia grade 3 (CIN3) and can be incorporated into clinical management strategies. The guidelines note that compared with cytology, dual stain requires fewer colposcopies and detects CIN3 or greater earlier.1

For more specific uses on how dual stain can be used, go to the ASCCP web site. 

Enhancing cervical cancer management with dual stain

Find out more about cervical cancer management guidelines from Roche’s Carolyn Kay, M.D.

Is there evidence to back up these recommendations?

Yes. Roche has conducted the IMPACT trial that supports its FDA labeling. 

However, ASCCP guidelines call out more recent studies – the Kaiser Permanente Northern California (KPNC) cohort and the Studying Risk to Improve Disparities (STRIDES) study – that were both conducted among diverse populations and support its guidelines.

 

Is there a connection between health equity and diverse trials?

Yes, the National Institute on Minority Health and Health Disparities says it is essential to have a wide range of people from different communities participate in clinical trials to reduce bias, promote social justice and health equity, and produce more innovative science.2

What do new ASCCP recommendations mean for dual-stain technology

The IMPACT trial design, used to validate the clinical benefits of the Roche cervical cancer portfolio, had representation from diverse patient segments, including: 

pie chart

The IMPACT trial design, used to validate the clinical benefits of the Roche cervical cancer portfolio, had representation from diverse patient segments, including 21% Black, 24% Hispanic and 0.3% American Indian or Alaskan Native participants. 

The KPNC cohort is approximately 44% white, 20% Hispanic, 20% Asian, and 10% Black, with the remainder mixed race or other and the majority of KPNC patients have employer-based insurance.3 The Mississippi State Department of Health (MSDH) population in STRIDES is approximately 25% white, and 58% Black/African American, with the remainder mixed race or other. Approximately 80% of MSDH clinics are located in rural areas, and cervical cancer screening services are covered by public funding at MSDH clinics.4

This diversity is critical to accurately assess the performance of dual stain in patient populations with higher incident rates of HPV.5

 

References

  1. Wentzensen,Nicolas. Journal of Lower Genital Tract Disease 28(2):p 117-123, April 2024. | DOI: 10.1097/LGT.0000000000000804.
  2. Last accessed April 23, 2034. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html.
  3. Gage, J.C., T. Raine-Bennett, M. Schiffman, et al., The Improving Risk Informed HPV Screening (IRIS) Study: Design and Baseline Characteristics. Cancer Epidemiol Biomarkers Prev, 2022. 31(2): p. 486-492.
  4. Risley, C., M.W. Stewart, K.R. Geisinger, et al., STRIDES - STudying Risk to Improve DisparitiES in Cervical Cancer in Mississippi - Design and baseline results of a Statewide Cohort Study. Prev Med, 2021. 153: p. 106740
  5. Wright TC Jr, Stoler MH, Ranger-Moore J, Fang Q, Volkir P, Safaeian M, Ridder R. Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial.Int J Cancer. 2022 Feb 1;150(3):461-471. doi: 10.1002/ijc.33812. Epub 2021 Sep 25.