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our Premium Content: News alerts, weekly reports and conference plannersTEST:SafeSEQ AML MRD Assay
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News alerts, weekly reports and conference planners
Company:
Sysmex CorpType:
Laboratory Developed Test
Related tests:
over2years
Sysmex Inostics expands blood test offerings for detection of acute myeloid leukemia (Sysmex Press Release)
"Sysmex Inostics...has expanded its offering of CLIA-validated tests to include AML-SEQ™, a focused panel to detect mutations of the three most prevalent genes found in Acute Myeloid Leukemia (AML) – IDH1/2 & NPM1...AML-MRD-SEQ is a more extensive panel for the detection of measurable residual disease (MRD) in 68 regions across 20 genes including the clinically established IDH1/2 and NPM1."
Clinical
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SafeSEQ AML MRD Assay
over3years
[VIRTUAL] Rapid liquid biopsy genotyping in NSCLC patients (ELCC 2021)
The median mutant allele frequency (MAF) for all mutations detected by OncoBEAM was 0.50% (range: 0.04–50.84%), where 64% and 23% of mutations were detected with MAF <1% and <0.1%, respectively. Concordance of results between OncoBEAM and SafeSEQ in 176 replicate samples revealed an overall percent agreement of 99.6% with strong linear correlation of MAF (R2 = 0.98).Conclusions OncoBEAM LB enables sensitive and accurate genotyping results within 5 days, ∼3x faster than the TAT of tissue genotyping results, which carries significant implications for enabling rapid implementation of targeted therapies for NSCLC patients
Clinical • Liquid biopsy
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase)
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BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • ALK fusion • EGFR C797S • ROS1 fusion • KRAS G12
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OncoBEAM EGFR v2 Kit • OncoBEAM RAS CRC kit • SafeSEQ AML MRD Assay
4years
[VIRTUAL] Ultrasensitive Measurable Residual Disease (MRD) Detection in Acute Myeloid Leukemia (AML) Using a Targeted Next Generation Sequencing (NGS) Panel (ASH 2020)
"The SafeSEQ AML MRD assay demonstrates ultra-sensitive detection of low frequency mutations, with an LoD95 of 5 MM (0.025% MAF for 20,000 GE DNA input), while specificity remains very high. Similar to other SafeSEQ platform configurations, this performance is comparable with data obtained using the BEAMing dPCR technology; it is also orders of magnitude more sensitive than broad pan-heme NGS tests. With this combination of ultra-high analytical sensitivity paired with clinically-informed genomic coverage, we anticipate the SafeSEQ AML MRD test will play a fundamental role in accelerating therapeutic development."
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • NRAS (Neuroblastoma RAS viral oncogene homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NPM1 (Nucleophosmin 1) • JAK2 (Janus kinase 2) • SF3B1 (Splicing Factor 3b Subunit 1) • PTPN11 (Protein Tyrosine Phosphatase Non-Receptor Type 11) • SRSF2 (Serine and arginine rich splicing factor 2) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • CEBPA (CCAAT Enhancer Binding Protein Alpha) • SETBP1 (SET Binding Protein 1) • GATA2 (GATA Binding Protein 2)
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BRAF mutation • IDH1 mutation • U2AF1 mutation
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SafeSEQ AML MRD Assay
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