LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples.
Five years after its initial investment in Maverick Therapeutics Inc., Takeda Pharmaceutical Co. Ltd. is exercising its option to buy the privately held company for a pre-negotiated up-front payment plus development and regulatory milestones of up to $525 million.