OGT delivers superior MRD detection capabilities with new SureSeq Myeloid MRD Panel

New York, USA, 22 Jan 2025. Today, OGT announces the North American launch of its new next-generation sequencing (NGS) SureSeq™ Myeloid MRD Panel, which provides a flexible NGS workflow for the detection of ultra-low frequency measurable residual disease (MRD)-associated biomarkers in acute myeloid leukemia (AML). This ultra-sensitive NGS panel leverages OGT’s expertise in hybrid capture to enhance the detection of the largest and most complex AML associated variants in key genes, such as large FLT3-ITDs, that often go undetected by previous generations of PCR-based enrichment technologies.

The ultra-sensitive detection of MRD in AML is a critical tool for advancing clinical research in AML. NGS-based AML MRD is being more widely adopted in drug development and studies aiming to improve clinical management of AML. Clinical research studies into MRD continue to drive deeper understanding of AML remission and relapse, including evidence highlighting that MRD negativity is associated with a better 5-year survival rate compared to MRD positive defined samples.¹ Being able to sensitively detect even a few residual leukemic cells provides a more comprehensive picture of the current AML status of a sample.

OGT’s new highly targeted SureSeq Myeloid MRD Panel enables the detection of 13 key AML MRD-associated biomarkers. Key targets include very large, ultra-low frequency FLT3-ITDs (even up to 300 bp) that are traditionally challenging to detect. This streamlined, guideline-driven panel content expands on OGT customer’s MRD detection capabilities to deliver a better understanding of the current AML status, and ensures genomic insights are not missed. Customers can also effortlessly adapt NGS workflows to meet all their sensitivity, sample batching and sequencing requirements - by selecting from a range of pre-optimized workflows, users benefit from the unmatched flexibility of this new NGS MRD panel.

OGT specializes in the development of superior hybrid capture technology that excels in the detection of complex structural variants and eliminates inaccurate calls caused by alternative PCR-based approaches. By employing OGT’s unparalleled bait design process, informed by the team’s unique expertise, the company has developed the SureSeq Myeloid MRD Panel to offer enhanced and reliable, superior detection.

“We know how important MRD detection is, and will continue to be, in AML” said Adrian Smith, CEO, OGT. “Advances in the understanding of AML MRD, such as recent research studies highlighting the prognostic ability of FLT3-ITD detection to ascertain the disease course for patients with AML pre- and post-HSCT, emphasize the need for sensitive NGS-based tools to be able to characterize this, and other, key variants in clinical research. We are proud to have developed our newest NGS panel that allows customers to detect key AML-relevant biomarkers, including NPM1 and FLT3-ITDs, at extremely low levels. With our complimentary software, Interpret, which provides an “out-of-the box” bioinformatics pipeline that can be tailored to customers specific requirements, we ensure our customers secure the most valuable insights from their MRD data.”

Discussing the successful use of OGT’s new MRD Panel, Professor Klaus M. Metzeler, Professor of Translational Hematology at the Department of Hematology, Cell Therapy, Hemostaseology and Infectious Diseases, University of Leipzig, Germany, said, “Overall, we were very happy with the promising results we obtained using the SureSeq Myeloid MRD Panel which has led us to implement this panel for MRD analysis in our ongoing and planned clinical trials. In our hands, this panel was able to detect all variants found by a comparator NGS Panel, generating no false positive calls; and most importantly, several additional clinically relevant variants were found, including FLT3-ITDs, that had not been detected by the comparator.”

OGT partners with all customers to get them started with their MRD analysis without adding to their lab’s bioinformatics burden and ensures their MRD workflows always operate seamlessly. The company’s complimentary NGS analysis software, Interpret, is available on the cloud or as a local install and provides a powerful bioinformatic analysis pipeline. This is all aided by OGT’s expert support team who are readily available to support customers in their workflow implementation and maintenance.

For more information about the SureSeq Myeloid MRD Panel and OGT's genomics solutions, please visit: www.ogt.com/sureseq

References

1. Short NJ et al. JAMA Oncol 2020;6:1890–1899. DOI: 10.1001/jamaoncol.2020.4600

About OGT

OGT, a Sysmex Group company, is a leading global provider of clinical and diagnostic genomic solutions that are created for scientists by scientists - including CytoCell^®, CytoSure^® and SureSeq ranges of FISH, microarray and NGS products. The company is dedicated to creating products that enable researchers and clinical decision makers to reach the right care decisions for each patient, every time. OGT strives to unlock the future of genetic clinical care with a commitment to working in partnership with its customers - not only by sharing its expertise of 25 years at the forefront of genetic endeavor, but also by working closely with scientists to understand their unique challenges, and to customize its approach to meet their exact needs. Dedicated to improving clinical care, OGT believes that through partnership—together—we’ll achieve more.

CytoSure, SureSeq and myProbes^®: For Research Use Only, not for use in diagnostic procedures. CytoCell: Some products may not be available in your region.

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. The company employs more than 10,000 employees worldwide. Sysmex Corporation is listed in the Prime Market on the Tokyo Stock Exchange.

For more information about Sysmex Corporation and its affiliate companies, please visit www.sysmex.co.jp/en/.