CINtec PLUS Webinar Series
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Optimizing triage of HPV positive patients with p16/Ki67 dual stain biomarkers: Singapore experience

Thursday, 16th May 2024
13:00 - 14:00 (GMT +8)
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The goal of cervical cancer screening is to detect precancerous lesions, which if left untreated, can develop into cervical cancer. While Pap cytology has had a positive impact on HPV and cervical cancer screening over the past 50 years, it is resource-intensive and subject to misinterpretation and missed disease.

By harnessing p16-Ki67 dual-biomarker immunocytochemistry, FDA-approved CINtec® PLUS Cytology serves as an objective indicator of transforming HPV infections in patients with abnormal Pap cytology and/or HPV-positive screening results.

In this webinar, our experts unveil how p16-Ki67 dual biomarker testing optimizes triage processes and allows lab professionals to help clinicians be more certain in selecting women who may benefit most from colposcopy and in follow up recommendations.

Join us in this session, as they share their experience with CINtec® PLUS biomarker testing, as a triage tool in managing patients with abnormal Pap and/or HPV-positive results.

Who should attend:

  • Gynecologists / Gyne-oncologists, Pathologists, Laboratory staff / lab scientists, Cytotechnologists, General practitioners, Health practitioners involved in women’s health, Residents/trainees or any professionals interested in understanding molecular diagnostics relevant to cervical cancer screening.

Key reasons to attend:

  • Learn about the latest advancements in cervical cancer screening with FDA-approved CINtec® PLUS Cytology, harnessing dual-biomarker p16-Ki67 immunocytochemistry, to enhance accuracy in detecting transforming HPV infections.
  • Discover how p16/Ki67 dual stain biomarker testing streamlines triage processes for HPV positive or abnormal Pap cytology results, enabling confident follow-up recommendations and improved patient outcomes.
  • Gain insights into how p16/Ki67 dual stain biomarker testing enables clinicians optimize cervical disease management workflow and resource allocation.

Faculty

Speaker

speaker1

Prof. Tay Sun Kuie

Senior Consultant Obstetrician and Gynecologist
Singapore General Hospital

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Speaker

speaker2

Dr. Sangeeta Mantoo

Senior Consultant, Anatomical Pathology
Singapore General Hospital

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Moderator

speaker4

Dr. Richie Lazaro

Regional Pathologist APAC
Roche Diagnostics Asia Pacific Pte Ltd

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Agenda

TIME

TOPIC

Speakers


13:00 – 13:05
Opening
Dr. Richie Lazaro

13:05 - 13:25
The value and role of dual-stain cytology using p16/Ki67 biomarkers, in triage processes and risk-based management of cervical cancer screening
Prof. Tay Sun Kuie

13:25 - 13:45
Implementation of dual stain cytology in the lab, and insights and challenges in routine practice
Dr. Sangeeta Mantoo

13:45 - 14:00
Q&A
All


Q&A

Dr Sangeeta Mantoo
Singapore General Hospital (SGH) uses only ThinPrep® PreservCyt® Solution. Reporting of all the CINtec PLUS cases are by both a cytotech and a cytopathologist, all of whom have been trained for reading such slides.
Roche Diagnostics

Cytological morphology is not evaluated in the dual stain result. During interpretation, we only look out for the presence of both p16 and Ki-67 stains within the same cell.
Dr Sangeeta Mantoo

We do not have any experience on the performance of the CINtec PLUS stain on conventional smears.
Dr Sangeeta Mantoo

We report these cases as follows: 1. "Positive for Cintec PLUS dual immunostaining" -
When at least one of the cells in the slide shows dual staining (red nuclear and brown cytoplasmic staining) –
2. "Negative for CINtec PLUS dual immunostaining" -
When in a satisfactory smear, no cell shows dual staining
3. "Unsatisfactory for interpretation, due to stated reason" (please refer to the webinar recording for more details)
"Comment: The information provided by CINtec PLUS Cytology test should be used together with the physician's assessment of screening history, other risk factors and professional guidelines to guide patient management."

We give a separate report for CINtec PLUS, as in our practice scenario, the request for doing CINtec staining is received separately, e.g. after a positive HPV molecular result.
Prof Tay Sun Kuie

We do not do extended genotyping. In the setting of partial genotyping, CINtec PLUS is an effective triage test for positive HPV-12others. CINtec PLUS positive cases should be referred for colposcopy. CINtec PLUS negative cases can have an extended interval of 3years for repeating screening.
Prof Tay Sun Kuie

For primary cytology screening without HPV, the role of CINtec PLUS in triaging low-grade squamous intraepithelial lesion (LSIL) or atypical squamous cells of undetermined significance (ASC-US) for referral to colposcopy is currently undefined. I don’t have data to support any recommendations.
Dr Sangeeta Mantoo

Even a single cell positive for the dual stain is reported as a positive test.
Dr Sangeeta Mantoo

I do not have a number for false positive rate for this test. Even a single cell positive for the dual stain is reported as a positive test.
Dr Sangeeta Mantoo

As per the Enduring Guidelines consensus publication for use of CINtec PLUS (Clarke et al.Journal of Lower Genital Tract Disease. 28(2):124-130, April 2024.) they suggest not to use the dual stain for cases with atypical glandular cells (AGC), high-grade squamous intraepithelial lesion (HSIL and ASC-H) on cytology, as these should go for colposcopy regardless of CINtec PLUS result.
We have not done a study looking at the performance of CINtec PLUS in glandular lesions as such. We have reported positive CINtec PLUS in a few cases of endocervical adenocarcinoma in situ (AIS) and adenocarcinoma (which were also confirmed to be HPV associated (p16 immunostain positive) on histology or high risk-HPV positive by molecular testing).
We have not looked at the false positive/ negative rates of this test. As per the numerous studies in literature these are certainly some issues to think about. This is a relatively newer stain and may not have adequate follow up in the studies. I would think that a number of such cases could also have an element of interpretative issue if the specimen is otherwise satisfactory, and stained as per stringent protocol as proposed by the company. Some element of subjectivity is certainly there when reading this stain, in our experience.