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Cervical Cancer Products

CINtec® Histology: Be conclusive in diagnosing cervical precancer
 

CINtec® Histology provides objectivity to diagnostic interpretation that helps all pathologists identify more cervical disease. The CINtec® Histology test is the only p16 biomarker test CE marked and U.S. 510(k) cleared for clinical use in the evaluation of cervical biopsy specimens. Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency and diagnostic agreement between each other and with expert gynecopathologists.1

CINtec® Histology enhances identification of occult lesions that may be missed by H&E or morphologic interpretation alone, adding objectivity to cervical biopsy interpretation to help pathologists make informed diagnoses. The adjunctive use of CINtec® Histology helps pathologists ensure the right patient is treated without unnecessarily treating more patients.

Source: CINtec® Histology IFU 2017. Results based on the percent agreement of the majority of pathologists with expert pathologists when all pathologists use H&E along with CINtec® Histology for diagnosing ≥CIN2.

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
Pathologists who use CINtec® Histology demonstrate improved diagnostic consistency with each other and with expert gynecopahologists.1

*Diagnostics performance by individual pathologists compared with the consensus diagnosis established by expert gynecopathologists using H&E along with CINtec® Histology.

Get detailed CINtec® Histology laboratory system information. 

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References

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