Date: 2011-07-19
Type of information:
phase:
Announcement: results
Company: Exonhit (France)
Product: EHT Dx14
Action mechanism: EHT Dx14 is a molecular biology test that is intended when assessing a suspicious tumor discovered during mammography to allow the accurate reading of samples obtained by FNA especially in cases where the standard analysis returns an indeterminate result. EHT Dx14 was able during the initial study to differentiate benign breast tumors from malignant ones in 96% of the cases.
Disease: breast cancer
Therapeutic area: Cancer Oncology
Country: France
Trial details:
Latest news: Exonhit has announced successful completion of the second phase of the validation study of EHT Dx14, a new transcriptomic signature allowing to differentiate, at molecular level, benign breast tumors from malignant ones. EHT Dx14 clinical validation was a two-step process. It first demonstrated in an independent set of malignant (47) and benign (47) FNA samples coming from the Institut Gustave Roussy biobank, a specificity of 91.5% and a sensitivity of 97.9%. The purpose of the second validation step was to demonstrate the added value of the test in the discrimination of 55 “difficult” samples for which the cytological analysis did not allow to conclude as it relates to the malignant or benign nature of the sample. The results showed a specificity of 81.8% and a sensitivity of 77.3%. Hence, when cytological analysis gives indeterminate results, EHT Dx14 is able to define the exact nature of breast tumor in close to 4 cases out of 5. By projection, taking into account the expected frequency of uncertain diagnosis in the general population, the adjusted global performance of EHT Dx14 is 93.4% (post hoc analysis); its specificity is 90.7% and its sensitivity, 96.1%. The test performance adjusted to the Institut Gustave Roussy prevalence is greater than 90% hence demonstrating the excellent performance of EHT Dx14 on the global FNA population processed at Institut Gustave Roussy. On the basis of these excellent results, Exonhit plans to offer EHT Dx14, as an Investigational Use Only Product, to major cancer centers in France, in autumn 2011.
