FLT3 Cancer Sequencing Panel Speeds Rapidly Improving, but Clinical Impact Studies Are Needed Premium Thermo Fisher Scientific's IonTorrent Genexus platform can provide cancer panel results in about a day, but data on clinical impact of the fast turnaround has not yet been produced. Invivoscribe Files FDA Supplemental PMA for CDx Test to Select AML Patients for Daiichi Sankyo Drug The assay will be used to identify FLT3-ITD-positive AML patients who can benefit from treatment with Daiichi Sankyo's quizartinib. Invivoscribe, Kronos Bio Partner on Companion Diagnostic Test for Leukemia Drug The companion diagnostic assay would identify mutations in the NPM1 gene, which Kronos Bio is targeting with its investigational drug entospletinib. Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug 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. Single-Cell Sequencing Proves Useful for Tracking Drug-Resistant AML Mutation Progression Premium Researchers used Mission Bio's Tapestri assay to identify and monitor the evolution of cancer mutations in acute myeloid leukemia in response to targeted treatment. Apr 1, 2019 FLT3 Inhibitor Treatment Improves Survival in Relapsed, Refractory AML Patients With Mutations Mar 12, 2019 First Veterans Affairs MDx Lab Launches NGS-Based Cancer Panel; Others to Follow Premium Nov 28, 2018 Invivoscribe CDx Assay Gets Expanded FDA Approval Alongside Astellas AML Drug Nov 27, 2018 Invivoscribe Submits FLT3 Mutation CDx Assay to FDA Nov 19, 2018 Invivoscribe Submits FLT3 Mutation Assay CDx to Japanese Regulators Sep 27, 2018 Invivoscribe Receives Regulatory Approval for FLT3 Mutation Assay in Japan Jun 26, 2018 Rare Immune Cells, Cytokine May Predict Response to Cancer Immunotherapy May 8, 2018 Invivoscribe Submits Regulatory Applications in Japan, US for AML CDx Feb 6, 2018 Sophia Genetics Gains CE-IVD Mark for Leukemia Assay Aug 1, 2017 Invivoscribe Garners CE Mark for LeukoStrat CDx FLT3 Mutation Assay Apr 28, 2017 FDA Approves Rx/Dx Combination for Acute Myeloid Leukemia Jan 31, 2017 Invivoscribe, Thermo Fisher to Develop FLT3 Mutation, Clonality Assay Kits Mar 20, 2015 Genection's AML Panel First of Several NGS-based Dx Tests it Plans to Bring Through FDA Clearance Premium Nov 19, 2014 Dana-Farber, Brigham and Women's Develop NGS Panel for Rapid Diagnosis of Hematologic Cancers Premium Dec 14, 2011 Plexxikon Launching Phase I/II Trial for PLX3397 in AML Patients with Flt3 Mutations Premium Feb 23, 2011 Novartis, Invivoscribe to Develop Companion Test for Acute Myeloid Leukemia Rx Midostaurin Premium Breaking News FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests CStone Pharmaceuticals, Genetron Companion Diagnostic Receives NMPA Approval In Brief This Week: Pacific Biosciences, Ginkgo Bioworks, Twist Bioscience, Novacyt, Grail, More Plasmid Transfer Let Cholera Pathogen in Yemen Become Multidrug Resistant, Study Suggests Harbinger Health Raises $140 Million in Series B Financing The Scan Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants. Small Study of Gene Editing to Treat Sickle Cell Disease In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms. Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema. Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.