CARLSBAD, Calif.– Thermo Fisher Scientific today launched a next-generation sequencing (NGS)-based assay for research in myeloid measurable residual disease (MRD). 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.
Acute myeloid leukemia (AML) is characterized by rapid disease progression and can be fatal if not treated promptly. Depending on their interventions, the number of AML patients who experience relapsed disease can be as high 78%1. Detecting remaining mutations after treatment can help identify the presence of residual disease and guide patient prognosis and further treatment decisions. This is driving a growing need for an MRD detection methods that can simultaneously track mutations across multiple genes with high sensitivity.
Current MRD detection methods do not evaluate individual mutations or can only track a very 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,” said Luca Quagliata, global head of medical affairs at Thermo Fisher Scientific. “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, with the goal of improving care and advancing treatment development for patients with AML.”
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.
“There is a critical need for more effective disease monitoring and treatment for patients with AML who are at high risk of relapse. The MRD biomarker will be used to better understand disease progression and guide therapy decisions in the future, and as such MRD assessment is becoming an important part of cancer research today,” said Bevan Tandon, MD, director of hematopathology and molecular pathology at Pathline, a leading provider of specialized pathology services. “By introducing an assay that can be evaluated as a more accurate and comprehensive way to measure residual disease, we can begin to make strides to realize the true clinical potential of MRD to improve patient outcomes.”
