In hematology oncology, it is critically important to understand the genetics driving acute malignancies to quickly determine how best to address the disease. Thermo Fisher Scientific has announced a new portfolio of hematology-oncology assays for the Ion Torrent Genexus System* designed to enable a future in which turnaround times for next-generation sequencing (NGS) results can be reduced to less than 24 hours.
The Oncomine Myeloid Assay GX* is the first in a series of clinical research assays available from the new suite of hematology-oncology solutions. The new panel enables simultaneous analysis of DNA mutations and RNA fusion transcripts in myeloid samples in a single day. It also provides researchers the ability to profile 40 DNA targets and 29 fusion driver genes, enabling detection of more than 600 fusion isotypes to identify biomarkers associated with myeloproliferative neoplasm (MPN), acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Traditionally, analyzing myeloid samples involves serial single-gene testing to determine the mutation's specific genetic drivers, a process that can be laborious and time-consuming as the number of known biomarkers continues to grow. Yet in AML, conditions can deteriorate quickly, driving the need for rapid results. In such cases, clinicians today commonly request STAT testing, which requires pushing the sample to the front of the queue for immediate analysis, potentially disrupting the laboratory's workflow.
"Once histopathological analysis comes back with the diagnosis of AML, in many cases instantaneous decisions have to be made. Commencing appropriate treatment within 24 hours of identifying the disease will represent a significant step towards achievement of improved outcomes," said Kojo Elenitoba-Johnson, M.D., director of the Center for Personalized Diagnostics at the University of Pennsylvania's Perelman School of Medicine. "A simplified, automated workflow that provides comprehensive NGS results in a single day would be a game-changer for laboratories and patients in the future."
The Oncomine Myeloid Assay GX maximizes detection of relevant biomarkers, including TP53, CEBPA, NPM1, RUNX1, PML-RARA, IDH 1, IDH 2 and FLT3-ITD, a common driver mutation that is associated with poor prognosis in AML. The European LeukemiaNet recently recommended FLT3 analysis for AML, with results required in three days. Additionally, hematologists now call for optimized, multigene platform analysis that includes FLT3 mutations.
Thermo Fisher plans to introduce additional hematology-oncology clinical research assays for B-cell and T-cell clonality and somatic hypermutation assessment through immune repertoire sequencing to study lymphoid malignancies, including chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and Hodgkin's and non-Hodgkin's lymphomas. Additionally, Thermo Fisher will introduce a lymphoid gene panel covering a comprehensive set of targets relevant for a range of lymphoid neoplasms. All assays will be available for the Genexus System, the first fully integrated NGS platform to feature an automated workflow that delivers results economically in a single day.
"We are driven to provide solutions that will enable our customers to generate answers faster in areas where NGS can make a real difference for the future of healthcare," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Heme-oncology is another critical sector that is in need of this game-changing technology, which is why we will continue to innovate by expanding our portfolio of assays and work to democratize NGS."
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