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.
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.
The two companies are expanding a long-term collaboration to include development and commercialization of assays for the Applied Biosystems 3500Dx system.
The company is focusing on hematological malignancies and looking to partner with pharmaceutical companies for companion diagnostics.
The 95-gene test is for detecting leukemia, myelodysplastic syndromes, and myeloproliferative disorders and can return results in less than one week.
Originally published Dec. 12.
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.
Robert Redfield is floated as the next director of the US Centers for Disease Control and Prevention, the Washington Post reports.
The New York Times writes that the National Institutes of Health's All of Us Research Program is "ambitious" and that some are concerned it might be overly so.
Representative Lamar Smith's criticism of the National Science Foundation has "changed the nature of the conversation," according to ScienceInsider.
In PLOS this week: non-coding RNA function in yeast, transcriptomic profiles of malaria parasites, and more.