"During Q2, Biovica established its plan for clinical validation of DiviTum following feedback from the FDA, setting the timetable for the 510(k) submission to mid-2020. A contract was also signed with a US cancer group (SWOG) for analysis of a large study (approximately 400 patients) where the results will be fundamental for the FDA submission. More than 1,500 samples to be analyzed for the SWOG study (a study on metastatic breast cancer conducted by a US network of oncologists) have now been sent from the US. Results from the study are expected to create favourable conditions for subsequent clinical acceptance. The next steps will be to perform analytical validation (end of Q1’20e) and finally clinical validation."
Länk till uppdragsanalys nedan.