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The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.
The VA decided to bring this testing in house to streamline and standardize the process for doctors and gauge markers that are relevant to the veteran population.
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 agency approved Novartis' Rydapt for AML patients with FLT3 mutations, who will be identified by Invivoscribe's LeukoStrat CDx.
Invivoscribe and Novartis plan to develop an FDA-approved companion test for the investigational AML drug midostaurin and simultaneously launch the drug/test combination worldwide.
The two firms will develop a test to identify FLT3 positive acute myeloid leukemia patients who may benefit from Novartis' candidate drug midostaurin.
Novavax has begun a phase III trial of its SARS-CoV-2 vaccine, according to the New York Times.
Vox reports that the Trump Administration may limit student visas for individuals from some countries to two years.
The governor of New York says the state will conduct its own review of any SARS-CoV-2 vaccine, NPR reports.
This week in Science: Neanderthal Y chromosomes replaced by Homo sapiens Y chromosomes, and more.