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The test measures minimal residual disease and can be used to monitor patients eligible for discontinuation of treatment with Tasigna.
The test uses droplet digital PCR to detect BCR-ABL gene fusions and is intended for treatment response monitoring of chronic myeloid leukemia.
The firm said that entry into the market is a logical progression based on its existing position and strength in hematology, an adjacent segment.
The Swedish firm will use its CETSA technology to profile the effects of a drug on up to 6,000 proteins from patient blood samples.
RPRD will expand the availability of its PGx testing services to South Korea, and Orient Bio will diversify its business to include precision medicine and clinical PGx.
The firm recently announced that it is developing a new range of clinical flow systems that it expects to launch over the next five years.
The RealTime PCR instrument identifies AML patients with IDH2 mutations who can be treated with Celgene's Idhifa.
The test is intended to detect FLT3 mutations in order to select patients for treatment with Novartis' Rydapt, and has also been approved by the US FDA.
The test, the agency said, is the first authorized by it for use with flow cytometry to detect leukemias and lymphomas.
The agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.