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CERTAIN Study

CERTAIN Study - Clinical study excellence with impactful results

The (CERvical Tissue AdjunctIve aNalysis) study is one of the largest, most rigorous immunohistochemistry clinical studies.

As a result of the CERTAIN Study, CINtec® Histology achieved ≥ 99% acceptability for staining, morphology, and background.1 CAP (College of American Pathologists), the ASCCP and WHO (World Health Organization) recommend the adjunctive use of p16 IHC in evaluation of cervical biopsies.

 

Download the CINtec Histology CERTAIN study brochure.

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.

Peer-reviewed publication update

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

Global standard of care

 

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

CE marked and U.S. 510(k)

 

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.

Use of CINtec® Histology is supported by >100 peer-reviewed publications. 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. Learn more by accessing our training module on CINtec® Histology-CERTAIN Study.

CINtec Histology Training Module

LAST Recommendations

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

References

  1. Stoler et al. Am J Surg Path. 2018;42(8):1001-1009; https://journals.lww.com/ajsp/Fulltext/2018/08000/Routine_Use_of_Adjunctive_p16_Immunohistochemistry.2.aspx (Accessed 5 January 2021).
  2. Darragh et al. Arch Pathol Lab Med. 2012;136(10):1266-1297.
  3. Stoler et al. Tumours of the Uterine Cervix. In Kurman et al. (Eds.), WHO Classification of Tumours of Female Reproductive Organs. Lyon, France: IARC and WHO, 2014:169-206.
  4. Wright et al. The CERTAIN Study Result Adjunctive p16 Immunohistochemistry Use in Cervical Biopsies According to LAST Criteria, Am J Surg Pathol. 2021 epub ahead of print Apr 7; http://doi.org/10.1097/PAS.0000000000001709 (Accessed May 2021).