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Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
In granting de novo premarket authorization to ClonoSeq, the agency established its regulatory expectations for similar tests.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.
In a recent study in Blood, the researchers showed that a higher allelic burden after transplantation was associated with higher risk of relapse and mortality.
This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.
The companion diagnostic test identifies patients taking the Novartis drug Tasigna who are candidates for treatment-free remission monitoring.
Diagnostic WGS will be centralized and performed at the same Genomics England facility used in the 100,000 Genomes Project.
The five-year-old firm recently completed a clinical trial of the real-time PCR-based test, called ProALL-BM, on patients from a European National Registry Study.
Sophia Genetics has received a CE-IVD mark for a sequencing-based test that, combined with data analytics, is meant to improve detection of leukemia.
Abbott's Alinity h-series system integrates a standalone hematology analyzer and slide maker-and-stainer module to enable high-throughput complete blood counting.