This morning Angle Plc (LON:AGLE) reported initial results from its two lead clinical trials with Parsortix, a liquid biopsy system. The two studies ran in parallel in Europe (ANG-001) and the US (ANG-003) and explored Parsortix’s efficacy in triaging women with ovarian masses before surgery ie looking at whether the tumour is benign or malignant to estimate the extent of the necessary surgery. Both studies recruited 200 patients each and reported sensitivity was up to 95%, while specificity was much higher than existing tests. Angle has refrained from releasing further data, as it believes that the diagnostic algorithms (combining Parsortix findings, RNA markers and patient data) that were developed during the trials could be patented.
The next step is for the test to be optimised, as Angle believes some modifications to the analysis technique could improve performance still further. It will then seek to conduct validation studies to get the CE mark and FDA approval. The update on the further strategy is broadly in line with our expectations, although specific timelines for the validation studies are yet to be clarified. Notably, triaging is just part of the potential in ovarian cancer application. Parsortix captures circulating tumour cells and allows gene expression analysis to determine whether the tumour is malignant. The gene expression, however, could eventually also be used to select the most effective drugs. This would be highly desirable with neoadjuvant chemotherapy for example, when the drugs are given before the surgery. In general, gene expression profiling is widely perceived as one of the major tools for personalised medicine in the future.
To read the entire report Please click on the pdf File Below: