CINtec® Histology (p16)

CINtec Histology icon

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

Does your p16 meet the defined criteria for Class II devices like CINtec Histology (p16)?

  • Proven performance - repeatability, reproducibility and precision of a test is paramount for clinical labs to ensure they are reporting the right results.  The CERTAIN Study demonstrated the clinical utility and consistency in diagnosis across pathologists compared to an expert panel of pathologists specializing in cervical disease.
  • Real-time & accelerated stability and shipping stress testing -  CINtec Histology was developed under a rigorous assay development process.  This provides efficiency and confidence to your laboratory and confidence and certainty to your pathologists during interpretation.
  • Today, only CINtec Histology meets these criteria.  No other p16 IHC product meets these important FDA requirements.

Be conclusive – diagnose with CINtec® Histology

 

 

Clinical study excellence

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

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

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

CINtec Histology 23-30% more
CINtec Histology agreement icon
CINtec Histology 99.1% acceptability

Best-in-class

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

CINtec Histology helps pathologist be even better at what they do!

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.

 

Publications

 

  • 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