Objective: To establish the utility of a new molecular assay,Cervical DNA Dtex, for differentiating ASCUS/HPV+ or LSIL patients with increased risk for progression.

Methods: Patients presenting with abnormal Pap cytology and/or HPVpositive results were referred for Cervical DNA Dtex testing. Fluorescence in situ hybridization (FISH) was used to determine copy number of chromosomal regions 3q26 and 5p15. Test results from patients studied during January 2009 to January 2010 from one partner cytology laboratory are reviewed.

Results: Results for 619 patients from liquid based cytology, HR-HPV and Cervical DNA Dtex were reviewed. All patients were positive for HR-HPV. Seventy-three percent of the patients showed low-grade ASCUS/LSIL and 7% had high grade cytology results. Cervical DNA Dtex test results and comparison to published rates for progression to CIN3 are summarized in Table 1.

Conclusion: Although clinical research has identified a high rate of regression within patients with ASCUS/HPV+ and LSIL cytology, the majority of these women will undergo colposcopy and biopsy. A high specificity molecular assay that identifies patients with increased risk of progression would have significant clinical utility for physicians to develop targeted management plans. We previously reported the Cervical DNA Dtex assay to have 98.3% specificity and 85.0% sensitivity. This Cervical DNA Dtex testing data shows the rate of 3q26 and 5p15 DNA abnormalities correlates with the published rate of CIN3 (Table 1). Specifically, 4.1% of the ASCUS/HPV+ and 11.8% of LSIL patients tested were Cervical DNA Dtex positive, similar to 3.5% and 8.10%, the respective ALTS published rate of CIN3. In conclusion, Cervical DNA Dtex is a highly specific molecular assay that has utility for the differentiation of patients with an increased risk of progression.