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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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 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.
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