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81551 Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1)Last reviewed at VbBS in November 2017. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. Prostate promoter methylation profilingCode: CPT 81551 Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsyBackground: Silencing of tumor suppressor genes through DNA methylation is a key process in the onset and progression of cancer. Testing prostate biopsy samples for the presents of DNA methylation has been proposed as a predictive test to determine which patients are at high or low risk of having prostate cancer found on future biopsiesEvidence:Van Neste 2016, cohort study N=803 patientsThe NPV of finding low levels of DNA-methylation in the combined cohort was 89.2% for all cancers. The positive predictive value (PPV) of the epigenetic assay performed on the index biopsies was 28.2% for detecting any cancer upon repeat biopsy.Conclusions: The risk score, comprising DNA-methylation intensity and traditional clinical risk factors, improved the identification of men with high-grade cancer, with a maximum avoidance of unnecessary repeat biopsies. This risk score resulted in better patient risk stratification and significantly outperformed current risk prediction models such as PCPTRC and PSA. The risk score could help to identify patients with histopathologically negative biopsies harboring high-grade prostate cancer.Study authors were employees of the company marketing the EpiScore testVan Neste 2017, cohort study N=102 patientsEpiScore was significantly higher for subjects with high-grade biopsies and higher NCCN risk categories (both P < 0.001). In patients diagnosed with GS ≥ 7, increased levels of DNA-methylation were present, not only in the high-grade biopsy cores, but also in other cores with no or low-grade disease (P < 0.001). By combining EpiScore with traditional clinical risk factors into a logistic regression model, the prediction of high GS reached an AUC of 0.82 (95%CI: 0.73-0.91) with EpiScore, DRE, and atypical histological findings as most important contributors.Conclusions: In men diagnosed with PCa, DNA-methylation profiling can detect under-sampled high-risk PCa in prostate biopsy specimens through a field effect. Predictive accuracy increased when EpiScore was combined with other clinical risk factors. These results suggest that EpiScore could aid in the detection of occult highgrade disease at the time of diagnosis, thereby improving the selection of candidates for Active Surveillance.Study authors were employees of the company marketing the EpiScore testExpert guidelinesEpiScore is not mentioned in NCCN 2017 Early Detection of Prostate CancerHERC staff summary: EpiScore appears to be an experimental test at this time based on limited research and lack of inclusion in NCCN guidelinesHERC staff recommendation: Add CPT 81551 Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy to line 660 CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; unproven treatments with an entry for GN173 as shown belowGUIDELINE NOTE 173, INTERVENTIONS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; unproven INTERVENTIONSThe following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN INTERVENTIONS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; unproven INTERVENTIONS for the conditions listed here:CPT/HCPCS codeINTERVENTIONRationaleDate of last Review81551Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1)Unproven interventionNovember, 2017 ................
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