Thermo Fisher Scientific has introduced a next-generation sequencing (NGS)-based test, Ion Torrent Oncomine Myeloid MRD Assay, for the detection of measurable residual disease (MRD) in myeloid malignancies.
The new assay, which is available for research-use-only (RUO), is claimed to be the first NGS-based test developed to provide simultaneous analysis of DNA and RNA for myeloid MRD assessment.
It uses blood and bone marrow samples and provides a complete and highly sensitive MRD assessment.
Delivering results within two days, the new Myeloid MRD Assay enables the testing and identification of over 90% of common acute myeloid leukaemia (AML) mutations and fusions simultaneously.
It provides sensitive and comprehensive sample amplification of relevant DNA mutations and fusion transcripts that are associated with myeloid disorders in a single NGS run.
The company stated that the end-to-end workflow, with an integrated informatics pipeline and a reporting tool of the assay, will reduce the users’ hands-on time and time to results.
Thermo Fisher Scientific medical affairs global head Luca Quagliata said: “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.
“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.”
AML is identified by rapid disease progression, and about 78% of patients experience relapsed disease depending on their interventions.
According to the company, the existing MRD detection methods are not effective in evaluating individual mutations and can track only a limited number of mutations at once.
The new Ion Torrent Oncomine Myeloid MRD research assay enables detection as low as 0.05% allele frequency for important DNA mutations in 33 genes and assesses over 900 isoforms in 43 RNA fusion driver genes.
Recently, Thermo Fisher Scientific reported $10.97bn revenue in the second quarter of the year, representing an 18% increase compared to the same quarter last year.