Be conclusive – diagnose with CINtec® Histology
The CINtec® Histology test is the only advanced p16 biomarker test FDA cleared for clinical 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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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 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.
Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency and diagnostic agreement between each other and with expert gynecopathologists1.
The CINtec® Histology test is the only clinically validated test to provide clear visual confirmation of the presence or absence of ≥CIN2 lesions.
19,250 CINtec® Histology slide interpretations by community pathologists confirmed ≥ 99.1% acceptability for staining, morphology and background1.
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 finds 22.8% more high-grade disease1. These women can now be treated appropriately.
Use CINtec® Histology to put the spotlight on disease
1CINtec® 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