LOXO ONCOLOGY,INC. (NASDAQ:LOXO) Files An 8-K Other EventsItem 8.01 Other Events.
On September15, 2018, as previously announced, Ventana Medical Systems,Inc. (“Ventana”) and Loxo Oncology presented a co-authored poster on the analytical validation of Ventana’s pan-TRK IHC assay at the Molecular Analysis for Personalised Therapy 2018 Congress in Paris, France. Representative tumor samples were screened for the presence of an NTRK fusion, which allowed for incidence calculations by tumor type, and in turn, an estimate of advanced NTRK fusion cancer cases in the United States. These data, in addition to other recently published evidence, suggest an annual incidence of approximately 2,500 to 3,000 cases in the United States. However, uncertainty remains around the treatable or “addressable” number of patients with advanced NTRK fusion cancer for a variety of reasons, including the uncertainty of and constantly changing number of patients who are referred for comprehensive tumor testing and the variable sensitivity for NTRK fusions in assays used to analyze tumor samples from referred patients. The broad utilization of sensitive diagnostic tests in routine clinical practice, capable of reliably identifying NTRK fusions, is and will continue to be critical to our evolving understanding of the addressable annual incidence of this cancer.
