Date: 2012-02-14
Type of information:
phase:
Announcement: results
Company: Epigenomics (Germany-USA)
Product: Epi proLung® BL assay
Action mechanism:
Disease: lung carcinoma
Therapeutic area: Cancer Oncology
Country: Germany
Trial details:
Latest
news: Epigenomics has announced the results from a clinical study conducted by Professor Dr. Manfred Dietel and his team from the Institute of Pathology of the Charité University Hospital in Berlin, Germany. In the reported study, the clinical performance of the Epi proLung® BL assay (based on Epigenomics’ proprietary biomarker detecting methylated SHOX2) was evaluated in bronchial washings from patients suspected of having lung carcinoma.
In the prospective study conducted between March 2011 and November 2011, a total of 228 bronchial washing specimens were submitted to cytological analysis according to established clinical routine. In addition, the Epi proLung® BL assay was performed on all patient samples. Final clinical status indicated that 54 of the 228 subjects were definitively diagnosed with lung carcinoma. Of the 54 confirmed lung carcinoma subjects, 29 were detected by both tests, 12 were detected by the Epi proLung® BL assay only, and 12 were detected by cytological analysis only.
The combination of both cytological analysis and the Epi proLung® BL assay resulted in a final sensitivity of 98% at a specificity of 92%. Only one confirmed lung cancer case was missed with the combined analysis.
Based on these results, which independently confirm the clinical utility of the Epi proLung® BL assay, Charité has announced that the assay will be introduced into its clinical practice as a routine aid in the diagnosis of lung cancer in patients with negative or suspicious cytological results.
The results of this study will be presented by Prof. Dr. M. Dietel at the Annual Meeting of the German Association of Pathologists end of May in Berlin.
