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The study will compare whole-genome sequencing and RNA sequencing to conventional diagnostic methods in about 450 acute leukemia patients in Sweden.
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.
The firm withdrew its 2020 revenue guidance and missed Wall Street estimates for both revenues and earnings.
Test volumes, revenues per test and costs per test improved during the quarter, the company said.
Adaptive said that Q4 clinical testing volume for its ClonoSeq sequencing assay for minimal residual disease increased 66 percent to 3,218 tests.
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.
Palmetto has expanded coverage of the ClonoSeq assay to include monitoring MRD testing for patients with chronic lymphocytic leukemia (CLL.)
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.