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Clinical Study Using Trovagene’s Precision Cancer Monitoring Platform Published in Cancer Discovery

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Trovagene, Inc., (NASDAQ: TROV) a developer of cell-free molecular diagnostics, recently announced the publication of clinical study results in a peer-reviewed journal, Cancer Discovery, featuring the Company’s precision cancer monitoring technology and its ability to non-invasively determine oncogene mutation status and monitor response to BRAF inhibitor therapy in patients with histiocytic disease, a malignancy often associated with BRAF mutations. Study investigator Eli L. Diamond, M.D., a neuro-oncologist at Memorial Sloan Kettering Cancer Center, will present the clinical results at the 30th Annual Histiocyte Society Meeting on October 28 in Toronto, Canada.

The blinded prospective study in patients with systemic histiocytic disease, such as Erdheim-Chester Disease (ECD) and Langerhans Cell Histiocytosis (LCH), demonstrates that analysis of circulating cell-free DNA (cfDNA) from urine provides a convenient and reliable method to detect the presence of the BRAF V600E mutation and to monitor mutational load repeatedly for assessment of treatment response. Results showed 100% concordance of BRAF V600E status between urinary cfDNA and tissue biopsies in treatment naive patients. Study authors conclude that cfDNA BRAF V600E mutational analysis in urine provides a convenient and reliable method of detecting mutational status and can serve as a non-invasive biomarker to monitor response to therapy in LCH and ECD. 

“More than 50% of patients diagnosed with ECD or LCH harbor the BRAF V600E mutation and might respond well to BRAF inhibitor therapy,” stated Omar Abdel-Wahab, M.D., a hematologist/oncologist at Memorial Sloan-Kettering and principal study investigator. “This study demonstrates that we can now reliably diagnose patients quickly and non-invasively using a liquid biopsy, and that we also now have the ability to monitor treatment response over time to ensure that the targeted therapy is the right choice for the individual patient.” 

In addition to the very high concordance demonstrated between urinary cell-free DNA and tissue biopsy, the study demonstrated that Trovagene’s assay was able to determine BRAF mutational status in all cases when the analysis of tissue biopsies provided inconclusive results. Longitudinal tracking of the BRAF V600E mutation in urine also correlated to therapeutic response as assessed by radiographic evaluation of disease. 

“Both ECD and LCH are thought to be substantially under-diagnosed, often due to the difficulty in obtaining an accurate histological diagnosis,” stated Carlos Rodriguez-Galindo, M.D., Dana-Farber Cancer Institute, an affiliate of Harvard Medical School, and president of the Histiocyte Society. “This non-invasive test may provide an additional tool to help in the diagnosis of those patients whose tumors harbor the BRAF V600E mutation and to monitor the response to treatment.”

Source: PR Newswire