CINtec^® Histology

Be conclusive – Diagnose with CINtec^® Histology

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

10x magnification

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.

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

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.

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.

References

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