The Role of Rapid NGS Testing in the MyeloMATCH Trial Initiative for AML and MDS

Physicians now have several therapeutic options available for AML patients, including multiple targeted therapies that have been approved in recent years. However, determining the most effective treatment strategy and therapy combination for a given patient is a complex task. By identifying specific mutations associated with a patient’s disease, clinicians can infer optimal therapeutic regimens for individuals based on their genomic profile, potentially improving patient outcomes.

In the MyeloMATCH trial, AML patients will have samples drawn at one of the participating national clinical trial network (NCTN) sites. Within 72 hours of the molecular laboratory receiving the sample, it will undergo rapid NGS, flow cytometry, and genetic analysis to generate data for a Matchbox report. The NGS testing will be conducted using the Ion Torrent Genexus System, a comprehensive NGS solution that automates the entire workflow for the NCI Myeloid Assay.

The analysis will be carried out at the NCI Molecular Characterization Laboratory (MoCha) at the Frederick National Laboratory for Cancer Research or at Fred Hutchinson. Flow cytometry will be concurrently performed at Children’s Hospital Los Angeles and cytogenetics will be conducted at Fred Hutchinson Cancer Center. Additionally, a significant number of samples will be sent to nationwide repositories for future research.

This combination of tests, representing the infrastructure of this trial, received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA). The NCI Myeloid Assay and the Genexus System were included in the IDE approval.

The data from the trial will inform a Matchbox report, an algorithm-driven approach based on multiple variables that will help assign the patient to a sub-study within 72 hours. This rapid process is crucial due to the urgency typically required for treating diseases like AML, where prompt treatment initiation can lead to better prognoses.

The MyeloMATCH trial, with its strategic application of NGS, is at the forefront of precision oncology for AML and MDS. The insights from the trial are driving the field towards more accurate and efficient diagnostic and therapeutic approaches. Several clinical sites are already open, with more to come. As NGS technology continues to evolve, our ability to manage and treat these complex diseases with unprecedented precision will also advance, thanks in part to studies such as MyeloMATCH and future technological innovations.