rochep16.info - CINtec® Histology, US-FDA

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

oncology (581) women's health (398) gynecology (288) cervical cancer (78) pathology lab (61) cintec (34) assays reagents and strips (34) histopathology (28) primary antibody (22) ihc primary antibodies (15)

Example domain paragraphs

The CINtec ® Histology test is an immunohistochemistry p16 biomarker test that is run on the BenchMark ULTRA IHC/ISH system, as well as BenchMark GX and the legacy Benchmark XT system.

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.