On December 5, 2020 Sysmex Inostics, Inc., a global leader and pioneer in blood-based, high-sensitivity molecular testing for oncology, reported the poster "Ultrasensitive Measurable Residual Disease (MRD) Detection in Acute Myeloid Leukemia (AML) Using a Targeted Next Generation Sequencing (NGS) Panel" at the 62nd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Virtual Meeting on Saturday, December 5th (Press release, Sysmex Inostics, DEC 5, 2020, View Source [SID1234572506]). Viewing time is between 7:00 AM and 3:30 PM (Pacific Standard Time)."

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AML is one of the deadliest blood cancers that takes over 10,000 lives in the U.S. each year. If cancer relapses after treatment, the prognosis is typically poor. Therefore, after initial treatment, patients are tested for MRD as a prognostic indicator of therapeutic effectiveness and relapse risk.

Groundbreaking FDA-approved AML therapeutics, such as ivosidenib, have been developed to target IDH1 mutations, which are present in about 5-10% of AML patients and can increase risk of relapse. Both newly diagnosed and relapsed/refractory AML patients with mutant IDH1 can benefit from IDH-directed therapy. In several clinical trials, the Sysmex Inostics OncoBEAM enhanced digital PCR technology has been used to monitor the levels of IDH mutations present in AML patients receiving targeted therapies. OncoBEAM technology is widely considered a gold standard for high sensitivity molecular testing and continues to be one of the most sensitive digital PCR approaches, capable of detecting mutations reliably at 0.02% mutant allele frequency (MAF).

Current NGS pan-heme panels lack sufficient sensitivity for reliable detection of molecular MRD, as their limits of detection are between 1-5% mutant allele frequency. Sysmex Safe-SeqS technology (SafeSEQ) dramatically expands the breadth of mutation detection for targets with established and emerging clinical validity for AML MRD while delivering comparable sensitivity to OncoBEAM. This highly sensitive, error-corrected NGS-based method can reliably detect molecular MRD present at levels as low as five mutant molecules, which is similar to the limit of detection observed across other SafeSEQ platform configurations and corresponds to 0.025% MAF for 20,000 genomic copies (66 ng of DNA) input.

In addition to demonstrating robust analytical performance, 100% overall agreement was observed between SafeSEQ and OncoBEAM for the detection of IDH1 mutations in clinical samples from AML patients. Furthermore, in almost all (94%) patients tested, at least one additional mutation outside of IDH1 was detected by the SafeSEQ AML MRD assay, which is consistent with previous observations that IDH mutations can co-occur with drivers in other genes such as NPM1 and may provide additive value for MRD detection.

"In order to deliver a powerful clinical tool for molecular MRD detection for AML patients, we developed the SafeSEQ AML MRD test to provide additional information across the most highly relevant genomic regions, with sensitivity comparable to the focused OncoBEAM method," said Matt Ryder, Director of Translational Science at Sysmex Inostics. "By offering reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus ‘pan-heme’ NGS tests, the Plasma-SeqSensei AML MRD test will help accelerate clinical development of novel therapeutics and, ultimately, provide oncologists with more reliable information on which to base important decisions for their AML patients."

Poster number 1078, "Ultrasensitive Measurable Residual Disease (MRD) Detection in Acute Myeloid Leukemia (AML) Using a Targeted Next Generation Sequencing (NGS) Panel" presented by Hillary Sloane, Associate Director of Medical & Scientific Affairs at Sysmex Inostics, will be available Saturday, December 5th from 7:00 AM to 3:30 PM (Pacific Standard Time) at the 62nd ASH (Free ASH Whitepaper) Annual Meeting during the Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis poster session number 617.