Detection of E6 and E7 mRNA transcripts has been shown to be of higher prognostic value for the evaluation of the precursor lesions of cervical carcinoma than the detection of HPV DNA in a number of pilot studies 123. In particular in low grade lesions, HPV DNA testing has poor discriminating power as to the progression of CIN, thus leading to considerable overtreatment with ensuing costs to the health care system. We tested an E6, E7 mRNA detection system in a multicenter study in Germany for its usefulness in clinical practice.

We recruited 334 high-risk ambulatory patients in five clinics with cervical lesions ranging from low-grade intraepithelial lesions to invasive cervical carcinoma. Colposcopy, conventional cytology, HPV-DNA testing (Hybrid Capture II, Digene Corp.), HPV-mRNA-testing (PreTect HPV-Proofer, NorChips AS, Norway) and histologic sampling (biopsies and conisations) were performed.

There were 140 patients WNL, 64 patients with CIN I/II, 98 patients with CIN III and 32 patients with invasive carcinoma. HPV-DNA testing was positive in 24%, 78%, 92% and 97%, respectively. E6/E7 mRNA positivity rate were 8%, 41%, 64% and 94%.

The mRNA-based test showed a higher prognostic value than DNA-based testing in a high-risk population of several dysplasia clinics in Germany. Thus, gene expression profiling of the viral oncogenes E6 and E7 showed superiority to DNA testing in triaging patients with cervical carcinoma precursors.