Pillar Biosciences Launches Kitted NGS Panel to Support Measurable Residual Disease (MRD) Detection in Acute Myeloid Leukemia (AML)

The research-use-only MRDTect™ NPM1 and FLT3 ITD Panel is Pillar's first product to support localized NGS-based MRD testing, uniting ultrasensitive NPM1 and FLT3-ITD detection in a single-tube, DNA-based workflow that laboratories can run in-house

NATICK, Mass., Oct. 22, 2026 /PRNewswire/ -- Pillar Biosciences, Inc., a leader in oncology-focused next-generation sequencing (NGS) solutions, today announced the launch of the MRDTect™ NPM1 and FLT3 ITD Panel, a research-use-only (RUO), kitted NGS panel for MRD detection in acute myeloid leukemia (AML). As the company's first MRD product, the panel detects NPM1 exon 12 mutations and FLT3 internal tandem duplications (ITDs) from a single genomic DNA input, down to 0.005% variant allele frequency (VAF). The launch is Pillar's first step in helping laboratories localize NGS-based MRD testing, bringing ultrasensitive molecular monitoring in-house on their existing NGS infrastructure rather than relying on centralized send-out testing.

MRD is a critical prognostic marker in AML, revealing treatment response and relapse risk beyond what morphology can show. The 2025 European LeukemiaNet (ELN) MRD recommendations call for leukemia-specific molecular markers measured at limits of detection of 10⁻⁴ to 10⁻⁵, and introduce ultrahigh-sensitivity NGS for FLT3-ITD-positive AML. Yet laboratories today either send out testing to centralized reference laboratories or test NPM1 and FLT3-ITD separately, using RNA-based qRT-PCR for one and complex hybrid-capture NGS with long-read sequencing for the other. That split adds sample input, cost, hands-on burden, and turnaround time. 

"MRD is where precision oncology is heading, and laboratories need tools that make ultrasensitive monitoring practical in-house," said ShiPing Zou, Ph.D., Sr. Director, Product Strategy and Portfolio Management of Pillar Biosciences. " MRDTect NPM1 and FLT3 ITD Panel is our first step in helping laboratories localize NGS-based MRD testing. It brings two of the most informative AML markers into one simple, kitted workflow that runs on the sequencers in their own labs, built on the same SLIMamp® chemistry our customers already trust."

Two critical markers, one workflow

The MRDTect NPM1 and FLT3 ITD Panel uses Pillar's proprietary Stem-Loop Inhibition-Mediated amplification (SLIMamp®) technology designed with the company's AI-empowered VersaTile™ Primer Design tool. Both targets are enriched in a simple, single-tube reaction and sequenced on standard 2 × 150 bp paired-end runs, with no long-read configuration required.

Key specifications and benefits include:

• Ultrahigh sensitivity: 100% detection of NPM1 and FLT3-ITD variants at 0.005% VAF (5 × 10⁻⁵) and above, within the ELN-recommended MRD range, with detections observed below that level.
• Broad FLT3-ITD coverage: detects ITDs from approximately 3 bp to more than 300 bp, including ultra-long ITDs that challenge existing testing methods.
• Simple, rapid workflow: single-tube library prep with about 3.5 hours of hands-on time, under 8.5 hours from DNA to sequencer, flexible stopping points, and sample-to-result in under 48 hours.
• DNA-based, low complexity: one genomic DNA input (500–700 ng for a target VAF of 10^-4; 700 ng for a target VAF of 10^-5) from blood, PBMCs, WBCs, or bone marrow avoids RNA pre-analytical variability and the need to divide specimens across different assays.
• Integrated informatics: PiVAT® analysis software processes each sample in about 3–10 minutes through a user-friendly interface, with dedicated long-indel and FLT3-ITD calling and built-in QC metrics.
• Scalable and economical: low read requirements (≥1.2M paired-end reads for target VAF of 10^-4; ≥8.9M paired-end reads for target VAF of 10^-5) support cost-efficient, high-throughput, in-house testing.

Together, these capabilities let laboratories run AML MRD testing with Pillar's kitted reagents and PiVAT® software on their existing sequencing instruments, consolidating two tests into one and keeping samples, data, and turnaround time under local control.

Performance demonstrated across internal and partner laboratories

Performance was characterized both internally and at four external partner laboratories, including a large commercial laboratory and an academic cancer center. Across more than 200 libraries from clinical samples and reference materials, the results demonstrate that the workflow can be run independently in a variety of laboratory settings. Median mapping rates exceeded 99% across all specimen classes, with approximately 99.2% of aligned reads on target and balanced NPM1 and FLT3 coverage.

A first step toward localized MRD testing

The MRDTect NPM1 and FLT3 ITD Panel is the initial step in Pillar's strategy to help more broadly localize NGS-based MRD testing. The company plans to build on the MRDTect platform to bring the same combination of sensitivity, simplicity, and affordability for the analysis of additional hematologic cancers over time.

The MRDTect NPM1 and FLT3 ITD Panel is for research use only. Not for use in diagnostic procedures.

About Pillar Biosciences

Pillar Biosciences is a global provider of next-generation sequencing (NGS) kitted solutions designed to deliver high analytical performance and operational efficiency for cancer testing. Powered by proprietary SLIMamp® and PiVAT® technologies, Pillar enables localized testing to expand access to complex molecular diagnostics worldwide. The company offers a growing portfolio of IVD and RUO NGS kits for tumor profiling, biomarker analysis, and molecular research and monitoring applications. For more information, visit pillarbiosci.com and connect with us on LinkedIn.

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SOURCE Pillar Biosciences, Inc.