A second publication from the CERTAIN study describes the clinical performance of p16 IHC (CINtec® Histology) when used according to the LAST recommendations. The data demonstrate that when CINtec® Histology is used according to LAST criteria, pathologists demonstrate improvement in diagnostic agreement, driven by improvements in diagnostic sensitivity and specificity for the identification of high grade cervical intraepithelial (CIN) lesions. In addition, for cases for which pathologists did not think they needed CINtec® Histology (non-LAST cases) there was a comparable increase in sensitivity and minimal difference in specificity.4
CAP (College of the American Pathologists), the ASCCP and WHO (World Health Organization) recommend the adjunctive use of p16 IHC in evaluation of cervical biopsies. Use of CINtec® Histology is supported by >100 peer-reviewed publications.2,3
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.
In 2012, CAP and ASCCP issued the Lower Anogenital Squamous Terminology (LAST) recommendations.2 The LAST recommendations introduce unified diagnostic terminology for HPV-associated squamous lesions of the cervix and lower anogenital tract, a measure intended to improve communication among pathologists and physicians, allowing for appropriate patient management.
To learn more about these consensus findings, please download The LAST Consensus Recommendations Brochure