The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
The company has multiple companion diagnostics partnerships in the works, with new tests on the way in 2020, and new plans for next-generation sequencing.
In a proof-of-principle study, Ohio State University researchers compared the nanopore sequencing assay to short-read sequencing and capillary electrophoresis.
The team will present the results to the US Food and Drug Administration as part of a 510(k) application in order to commercialize the technology with Biofluidica.
