Ventana Medical Systems, Inc., a member of the Roche Group, has announced that the World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease.(1) In doing so, the WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012.(1, 2)

Traditionally, the evaluation of cervical tissue samples has been performed using the slide-based hematoxylin and eosin (H&E) stain; however, this method of interpretation is subjective and diagnostic variability from pathologist to pathologist is well documented.(3) In some cases this variability may lead to unnecessary procedures or even false negative results.

During the Roche Cervical Cancer Symposium to be held in London as part of the European Congress of Pathology (ECP), Dr. Teresa Darragh, Professor of Clinical Pathology at the University of California in San Francisco and former president of the American Society for Colposcopy and Cervical Pathology (ASCCP), and Dr, Karin Denton, Consultant Cytopathologist and Q. A. Director at North Bristol NHS Trust, Southmead Hospital, Bristol, U. K., will present findings from the latest studies demonstrating the enormous contribution that advanced p16 biomarker-based tests can make to women's health.

"p16 is overexpressed in tissue specimens with transforming HPV infections and has proven to be an extremely reliable and useful marker particularly in cervical histological diagnoses," said Dr. Teresa Darragh. "Biomarkers such as p16 help give objective evidence to support our H&E diagnoses. They add 'science' to the morphological 'art' of interpretation."

Dr. Christine Bergeron, Director of Pathology and Cytology at Laboratoire Cerba and co-author of the WHO recommendations, explains, "Diagnostic studies have demonstrated that the use of p16 immunohistochemistry substantially improves the reproducibility and accuracy of (histopathologic) diagnoses. The adoption of the WHO recommendations and the use of p16 IHC will help address the substantial diagnostic variability present today. This will truly benefit the patient as this will help reduce unnecessary treatment but also help identify those women that should be treated."

"Cervical cancer is virtually preventable through screening and treatment of precancerous lesions, yet it remains the third most common cancer in women worldwide,"(4) said Ann Costello, VP, Lifecycle Leader for Advanced Staining Assays, Ventana Medical Systems, Inc. "The recent recommendations from the WHO further validate Roche's commitment to enhance cervical cancer screening and diagnosis for the improvement of women's health."