The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
The firm expects to begin distributing shipments of its FTL3 assay from LabPMM GK, the marketing authorization holder in Japan, in late 2018.
The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.
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.
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