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CINtec® Histology

Be conclusive – Diagnose with CINtec® Histology

CINtec Histology icon

Be conclusive – diagnose with CINtec® Histology

The CINtec® Histology test is the only 510(k) p16 biomarker for clinical/IVD use in the evaluation of cervical biopsy specimens.

Clinical study excellence

The CERTAIN study is one of the largest immunohistochemistry (IHC) clinical studies conducted in the US.

 

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CINtec Histology Certain Study data

Objectivity in cervical biopsy interpretation

When CINtec® Histology is used according to the LAST recommendations:

  • Diagnostic sensitivity improves by 11.8% and specificity improves by 9.7% to identify high-grade cervical disease1
  • Diagnostic consistency for high-grade disease of challenging cases by the majority of pathologists improves by 29.5%1

Be conclusive in diagnosing cervical pre-cancer using CINtec® Histology

CINtec Histology stain 10x magnification
10x magnification
CINtec Histology stain 10x magnification negative
CINtec Histology stain 40x magnification
40x magnification
CINtec Histology stain 40x magnification

CINtec® Histology enhances identification of occult lesions that may be missed by H&E or morphologic interpretation alone.

 

Agreement in diagnosis

The adjunctive use of CINtec® Histology helps pathologists ensure the right patient is treated without unnecessarily treating more patients.

The majority of pathologists using CINtec® Histology consistently identify 23% – 30% more high-grade cervical disease whether used on all biopsies or according to the LAST recommendations1.

CINtec Histology 23-30% more

Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency and diagnostic agreement between each other and with expert gynecopathologists1.

CINtec Histology agreement icon

Best-in-class

CINtec® Histology provides objectivity to diagnostic interpretation that helps all pathologists identify more cervical disease.

19,250 CINtec® Histology slide interpretations by 70 individual surgical pathologists confirmed ≥99.1% acceptability for staining, morphology and background1.

CINtec Histology 99.1% acceptability

You think you know what truth is?

In 100 women with disease:

  • When only H&E is used, the majority of pathologists could identify 71 of the disease cases1
  • When CINtec® Histology is used adjunctively with H&E – the majority of pathologists could identify 94 of the disease cases1
CINtec Histology truth statistics

CINtec® Histology finds 22.8% more high-grade disease1. These women can now be treated appropriately.

Use CINtec® Histology to put the spotlight on disease.

CINtec Histology stains

References

 

  1. CINtec® Histology 510(k) product package insert, 2017.

 

Key Publications to learn more

 

  • Darragh TM, Colgan TJ, Cox JT, et al. The lower anogenital squamous terminology standardization project for HPV-associated lesions: Background and consensus recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. J Low Genit Tract Dis. 2012;16:205-242. Erratum in J Low Genit Tract Dis. 2013;17:368.
  • Bergeron, C., et al, Conjunctive p16INK4a Testing Significantly Increases Accuracy in Diagnosing High-Grade Cervical Intraepithelial Neoplasia. Am J Clin Pathol 2010;133:395-406. DOI: 10.1309/AJCPXSVCDZ3D5MZM
  • Galgano, M, et al, Using Biomarkers as Objective Standards in the Diagnosis of Cervical Biopsies. Am J Surg Pathol. 2010;34:1077–1087.
  • Ordi, J., et al. p16INK4a Immunostaining Identifies Occult CIN Lesions in HPV-positive Women. International Journal of Gynecological Pathology 2008; 28:90–97. DOI: 10.1097/PGP.0b013e31817e9ac5

 

Related information

 

Online training for pathologists – CINtec® Histology-CERTAIN Study

Online training for pathologists – CINtec® Histology Interpretation 

CINtec® Histology Staining Pattern Guide

hpv16and18.com

cervicalbiomarkers.com

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