Thermo Fisher introduces assays for MRD detection in myeloid malignancies

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Thermo Fisher Scientific has launched a next-generation sequencing-based assay for research in myeloid measurable residual disease. 

As the first NGS-based tests to support both DNA and RNA input, the Ion Torrent Oncomine Myeloid MRD Assays (RUO) provide a comprehensive and highly sensitive MRD assessment from blood and bone marrow samples.

Current MRD detection methods do not evaluate individual mutations or can track a limited number at once. Thermo Fisher’s Myeloid MRD Assay has been designed to enable simultaneous testing and identification of more than 90% of common AML mutations and fusions, providing insights to guide the future of clinical applications, standards and drug development.

“MRD can help predict potential relapse in cancer patients but is not widely used for patients with AML due to lack of accurate, reproducible tests,” Luca Quagliata, global head of medical affairs at Thermo Fisher Scientific, said in a statement. “With the Myeloid MRD Assay, laboratories may perform comprehensive MRD analysis of mutations in myeloid samples to inform future clinical options. We are also working with the Foundation for the National Institutes of Health Biomarkers Consortium as they assess future requirements for validation and standardization of MRD as a biomarker.”

The Myeloid MRD Assay enables sensitive variant detection as low as 0.05% allele frequency for key DNA mutations in 33 genes and evaluation of more than 900 isoforms in 43 RNA fusion driver genes including many targets for which there are no established assays to-date. The end-to-end workflow delivers results in as little as two days with an integrated informatics pipeline and reporting tool that can help to minimize user hands-on time and speed up time to results.

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