Sysmex Inostics Presents Data at the American Society of Hematology Annual Meeting Demonstrating Exquisite Sensitivity of SafeSEQ NGS Technology for Detection of Measurable Residual Disease in Acute Myeloid Leukemia
BALTIMORE, Dec. 5, 2020 /PRNewswire/ -- Sysmex Inostics, Inc., a global leader and pioneer in blood-based, high-sensitivity molecular testing for oncology, is presenting 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) Virtual Meeting on Saturday, December 5th. Viewing time is between 7:00 AM and 3:30 PM (Pacific Standard Time)."
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.