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TEST:
CINtec® PLUS Cytology

Company:
Roche
Type:
FDA Approved
Related tests:
Evidence

News

2d
The importance of combined HPV and CINtec® PLUS genotyping testing for p16 in women with cervical squamous cell carcinoma. (PubMed, Rom J Morphol Embryol)
The p16 marker (CINtec® PLUS) can be used as a prognostic biomarker and provides clinical usefulness through increased sensitivity (Se) and specificity (Sp) in the triage of women at risk of developing precancerous lesions, compared to cytology that is based on morphology, but has a rather low Se and high Sp, while HPV testing is very sensitive but slightly more specific.
Journal
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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CINtec® PLUS Cytology
17d
New ASCCP cervical cancer management guidelines now include dual-stain triage testing with Roche’s CINtec PLUS Cytology to enable earlier diagnosis (PRNewswire)
"Roche Diagnostics today announced the release of new guidelines from ASCCP and other members of the Enduring Guidelines for Cervical Cancer Screening and Management Committee that now recognize dual-stain biomarkers as an important technology in helping clinicians triage patients to determine if their human papillomavirus (HPV) infection is transforming into cervical pre-cancer."
Clinical guideline
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CINtec® PLUS Cytology
22d
Recommendations for Use of p16/Ki67 Dual Stain for Management of Individuals Testing Positive for Human Papillomavirus. (PubMed, J Low Genit Tract Dis)
Dual stain testing with CINtec PLUS Cytology is acceptable for triage of HPV-positive test results. Risk estimates are portable across different populations.
Journal
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CINtec® PLUS Cytology
1m
Utility of CINtec® PLUS in Identification of High-grade Lesions on Short-Term Follow-up in Patients with Negative Cytologic Interpretation (USCAP 2024)
All three High-grade lesions were in the CINtec® PLUS positive category, suggesting CINtec® PLUS might help risk stratification for HPV-positive NILM women in both HPV16/18 vs. other HPV. Furthermore, CINtec® PLUS might be of help for risk stratification specifically in patients with no prior high-grade lesions.
Clinical
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CINtec® PLUS Cytology
2ms
Trial completion
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CINtec® PLUS Cytology • Precursor-M+/QIAsure Methylation Test
2ms
Surveillance Of Cervical Intraepithelial Neoplasia Grade 2 With Dual P16/Ki-67 Immunocytochemistry Staining. Preliminary Results Of The CIN2DIN Study. (ESGO 2024)
Two women tested positive for HPV16 and hrHPV (non-18); of those one had positive CINtec, and HGSIL cytology, and the other had negative CINtec and ASCH. Conclusion Among women with CIN2 the rate of a positive CINTEC+ test is lower than that of cytology testing, possibly reflecting a difference in the oncogenic potential of CIN2 cases.
CINtec® PLUS Cytology • cobas® HPV test
3ms
HIPPOPROJECT: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program. (clinicaltrials.gov)
P=N/A; N=33000; Active, not recruiting; Sponsor:Maria Sklodowska-Curie National Research Institute of Oncology
Trial completion date
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CINtec® PLUS Cytology • Precursor-M+/QIAsure Methylation Test
4ms
HPV genotype-specific distribution and attributable risk in cervical intraepithelial neoplasia in a referral population with a history of LSIL. (PubMed, Cancer Biomark)
Attributable risk of all HR-HPV genotypes targeted by both Anyplex and cobas tests was evident in ⩾CIN2/AIS Testing for these genotypes in HPV primary cervical screening and cytology triage could identify those at increased risk of cervical cancer and also be beneficial in the management of LSIL referral populations.
Attributable risk • Journal
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CINtec® PLUS Cytology • cobas® HPV test
7ms
CINtec PLUS Cytology Assay Is an Objective Biomarker Triage Test for ASC-US and LSIL Papanicolaou Cytology Results: A Study of 242 HPV-Positive Women With Follow-Up Colposcopy/Cervical Biopsy Results (CAP 2023)
CINtec PLUS Cytology objectively identifies transforming HPV infections in women with abnormal Pap cytology results and HPV-positive cervical cancer screening results. The high positive predictive value of dual-stained cytology for the presence of high-grade CIN may help reduce unnecessary colposcopy. It can help improve management of women with Pap cytology–negative/HPV+ results.
Clinical • Biopsy • Cytology
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CINtec® PLUS Cytology
8ms
Surveillance Of Cervical Intraepithelial Neoplasia Grade 2 With Dual P16/Ki-67 Immunocytochemistry Staining. Trial Protocol And Preliminary Report. (ESGO 2023)
So far, no studies have been conducted on the value of P16/Ki-67 ICC for CIN2 surveillance. If the study identifies high correlation of P16/Ki-67 ICC to colposcopy, larger studies could be designed to investigate longer-term reassurance for the surveillance of women with untreated CIN2 without colposcopy.
Clinical
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CINtec® PLUS Cytology • cobas® HPV test
10ms
Performance of p16/Ki67 Immunostaining for Triage of Elderly Women with Atypical Squamous Cells of Undetermined Significance. (PubMed)
Given the low sensitivity of cytology and the low percentage of HPV16-positive cancers among elderly women, triage via cytology and genotyping is not the best strategy; double staining cytology shows high profiles of sensibility and specificity for CIN2+ in ASCUS postmenopausal women.
Journal
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CDKN2A negative
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CINtec® PLUS Cytology
over1year
P16/Ki-67 Dual Staining in Positive Human Papillomavirus DNA Testing for Predictive Diagnosis of Abnormal Cervical Lesions in Northeastern Thai Women. (PubMed, Asian Pac J Cancer Prev)
P16/Ki-67 dual stain cytology in HPV-positive women performs well for diagnosis of abnormal cervical lesions and should be considered for management of HPV-positive women to avoid unnecessary colposcopy referrals.
Journal
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CINtec® PLUS Cytology
over1year
New trial
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CINtec® PLUS Cytology • cobas® HPV test
over1year
Can dual staining with p16 and Ki67 be biomarkers of epithelial dysplasia in oral lesions? (PubMed, J Cancer Res Ther)
In OSCC cases, alcohol intake showed statistically significant association with CINtec positivity. P16/Ki67 assessment by dual staining is a promising biomarker for identifying dysplasia in cases with diagnostic dilemmas.
Journal
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CINtec® PLUS Cytology
over1year
Journal
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CINtec® PLUS Cytology
almost2years
Evaluation of P16/Ki67 (CINtecPlus) and L1-capsid compared with HPV-genotyping in cervical cytology in women ≥35 years old focusing on patients with atypical squamous cells of undetermined significance. (PubMed, Oncol Lett)
In conclusion, there is still a need for conventional cytological examination and maybe the addition of immunocytochemistry to confirm the diagnosis and to exclude dysplasia of cervical epithelium. The HPV-HR-Test is not enough as a screening method and may be misleading.
Journal
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CINtec® PLUS Cytology
2years
A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women. (PubMed, Front Oncol)
The similar results were observed when identifying CIN2+. Dalton presents the lower false positive rate and better efficacy in identifying high-grade CIN than CINtec PLUS, suggesting that Dalton may be superior to CINtec PLUS and an alternative technique for triaging primary HPV-positive women in cervical cancer screening.
Journal
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CINtec® PLUS Cytology
over2years
IMPACT trial data shows clear benefit in using Roche’s CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer (Roche Press Release)
"Roche...announced that results from the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrate clear patient benefit in using Roche’s CINtec PLUS Cytology dual-stain biomarker technology as a triage test for women who test positive for high-risk human papillomavirus (HPV). The data from the trial, established from a study cohort of more than 35,000 women aged 25-65 years, was published recently in the International Journal of Cancer."
Clinical data
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CINtec® PLUS Cytology
over2years
LIBUSE trial – algorithm for cervical cancer screening with usage of HPV DNA testing with HPV 16/18 genotyping and p16/Ki-67 dual-stained cytology (ESGO 2021)
After 2 years of follow-up biopsy confirmed 38 HSILs and 2 glandular lesions, all of them were HPV positive. Conclusion* Screening based on HPV testing with selective 16/18 genotyping and p16/Ki-67 triage proved during three years four times more high-grade lesions including glandular lesions than standard screening based on Pap smears.
CINtec® PLUS Cytology • cobas® HPV test
over2years
Evaluation of HPV-Related Biomarkers in Anal Cytological Samples from HIV-Uninfected and HIV-Infected MSM. (PubMed, Pathogens)
The odds of HSIL increased almost 21 times in those positive for this biomarker. Our results encourage further investigation on the use of p16/Ki-67 dual staining in anal cancer screening for HIV-uninfected and HIV-infected MSM.
Journal
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CINtec® PLUS Cytology
over3years
[VIRTUAL] The use of P16/ki67 double-stain immunocytochemistry in liquid-based exfoliative cytology specimens to screen for precursor lesions of the anal canal cancer in patients infected with HIV (ECP 2020)
P16/Ki67 expression was observed in the only sample diagnosed as HSIL by biopsy, but only one of the seven samples diagnosed as low grade squamous intraepithelial lesion (LSIL) was p16/Ki67+. Conclusion The results suggest that p16/Ki67 immunostaining is a method that may be useful for improving cytology specificity in detecting high-grade anal squamous intraepithelial lesions.
Clinical
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CINtec® PLUS Cytology
over3years
[VIRTUAL] The use of P16/ki67 double-stain immunocytochemistry in liquid-based exfoliative cytology specimens to screen for precursor lesions of the anal canal cancer in patients infected with HIV (ECP 2020)
P16/Ki67 expression was observed in the only sample diagnosed as HSIL by biopsy, but only one of the seven samples diagnosed as low grade squamous intraepithelial lesion (LSIL) was p16/Ki67+. Conclusion The results suggest that p16/Ki67 immunostaining is a method that may be useful for improving cytology specificity in detecting high-grade anal squamous intraepithelial lesions.
Clinical
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CINtec® PLUS Cytology
over3years
[VIRTUAL] The use of P16/ki67 double-stain immunocytochemistry in liquid-based exfoliative cytology specimens to screen for precursor lesions of the anal canal cancer in patients infected with HIV (ECP 2020)
P16/Ki67 expression was observed in the only sample diagnosed as HSIL by biopsy, but only one of the seven samples diagnosed as low grade squamous intraepithelial lesion (LSIL) was p16/Ki67+. Conclusion The results suggest that p16/Ki67 immunostaining is a method that may be useful for improving cytology specificity in detecting high-grade anal squamous intraepithelial lesions.
Clinical
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CINtec® PLUS Cytology
over3years
Novel concepts in cervical cancer screening: a comparison of VIA, HPV DNA test and p16/Ki-67 dual stain cytology in Western Kenya. (PubMed, Infect Agent Cancer)
The poor sensitivity of VIA renders it unsuitable as a triage test for HPV positive women. The utility of p16/Ki-67 dual stain cytology as a triage test for HPV positive women in LMICs should be further studied.
Journal
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CINtec® PLUS Cytology
over3years
Exposure to tobacco smoke measured by urinary nicotine metabolites increases risk of p16/Ki-67 co-expression and high-grade cervical neoplasia in HPV positive women: A two year prospective study. (PubMed, Cancer Epidemiol)
HPV positive women exposed to tobacco smoke are at a higher risk of testing positive for p16/Ki-67 co-expression. Risk of high-grade disease is almost doubled in women who are exposed to tobacco smoke.
Journal • Clinical
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CINtec® PLUS Cytology
over3years
Dual staining for p16/Ki-67 to detect high-grade cervical lesions: results from the Screening Triage Ascertaining Intraepithelial Neoplasia by Immunostain Testing (STAIN-IT) study. (PubMed, Int J Cancer)
"Corresponding values considering an LSIL threshold were 42.8% (36.8-49.0) and 35.0% (30.1-40.1). Dual-stained cytology and HPV testing had similar performance, although the former improved the specificity by 7.9% and 9.6% for CIN2+ and CIN3+, respectively."
Journal
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CINtec® PLUS Cytology