Sysmex Inostics Expands Blood Test Offerings for Detection of Acute Myeloid Leukemia

Joins Foundation for the National Institutes of Health Biomarkers Consortium

BALTIMORE , May 24, 2022 /PRNewswire/ -- Sysmex Inostics, a global leader in the liquid biopsy revolution, has expanded its offering of CLIA-validated tests to include AML-SEQ™, a focused panel to detect mutations of the three most prevalent genes found in Acute Myeloid Leukemia (AML) – IDH1/2 & NPM1.

AML-SEQ rounds out the company's AML Laboratory Developed Test (LDT) offerings with a less expensive test compared to the broader AML-MRD-SEQ panel launched in October 2021. AML-MRD-SEQ is a more extensive panel for the detection of measurable residual disease (MRD) in 68 regions across 20 genes including the clinically established IDH1/2 and NPM1.

"We envision investigators and eventually physicians using AML-SEQ and AML-MRD-SEQ as a one-two-punch in the fight against AML and AML MRD. We are committed to developing tools to support the fight against this devastating disease. We must support management of patients suffering from AML by providing the accurate and sensitive detection of AML biomarkers," said Shinichi Sato, CEO of Sysmex Inostics, Inc.

AML-SEQ adds to the portfolio of ultra-sensitive Plasma-Safe-SeqS technology NGS tests available through Sysmex Inostics' CLIA lab services in Baltimore, Maryland.

Joins Foundation for the National Institutes of Health Biomarkers Consortium
Sysmex Inostics also announced that it has joined the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium's (BC) four-year project to validate new methods of MRD detection and quantification as a measure of response and trial endpoints in AML.

"At Sysmex Inostics, we are passionate about the fight against cancer. Being a part of this consortium is significant as it will contribute to advancing that fight by developing guidelines to better evaluate and manage AML MRD patients," said Sato. "Currently, it's a flip of a coin if a patient with AML will experience MRD, and the AML MRD 5-year disease-free survival rate of over 30%¹ is completely unacceptable," he concluded.

The FNIH consortium combines significant public and private organizations to develop AML MRD guidelines, establish methods for MRD detection, and achieve better measures for clinical trial design and drug development. Project partners include the National Cancer Institute (NCI), the National Heart Lung and Blood Institute (NHLBI), the U.S. Food and Drug Administration (FDA), several award-winning cancer institutions and leading pharmaceutical and diagnostic companies. For more information about the FNIH AML-MRD Consortium click here.

According to the National Cancer Institute (NCI), an estimated 20,050 new AML cases will be diagnosed in the United States in 2022.¹ Rising incidence of cancer and increasing preference of noninvasive treatments is driving the quick expansion of the liquid biopsy market. Globally, the liquid biopsy market is to achieve an annual growth rate of more than 18% over the next few years, reaching $5.8 billion by 2026.²

About Sysmex Inostics
Sysmex Inostics, Inc., a US-based Sysmex Corporation subsidiary, empowers discoveries in oncology by providing investigators cost-effective and ultra-sensitive quantitative liquid biopsy solutions.

Developed by experts at Johns Hopkins with the philosophy of "no molecule left behind," these technologies are optimized to ensure the detection of low-frequency mutant molecules (0.03%-0.05% MAF) with a high degree of specificity. Focused and flexible genomic coverage allows for superior sensitivity and reduced costs.

As forerunners of blood-based circulating tumor DNA (ctDNA) mutation detection, Sysmex Inostics has provided custom assays and CLIA-certified lab services to leading BioPharma companies over the last ten years to help monitor progression, identify targetable resistance alterations, and detect MRD throughout the clinical trial process.

In July 2021, Sysmex Corporation announced a global strategic alliance with QIAGEN to provide custom cancer companion diagnostics (CDx) utilizing Plasma-Safe-SeqS technology. The alliance is intended to promote early clinical implementation of Sysmex Inostics' technology to expedite clinical trial timelines for pharmaceutical companies that develop molecularly targeted drugs for cancer.

Sysmex Inostics offers a portfolio of highly sensitive NGS panels through its CLIA-certified laboratory in Baltimore, Maryland.

For more information, refer to www.sysmex-inostics.com or email info@sysmex-inostics.com.

References:

1. https://seer.cancer.gov/statfacts/html/amyl.html
2. https://www.marketsandmarkets.com/Market-Reports/liquid-biopsy-market-13966350.html?gclid=CjwKCAiAg6yRBhBNEiwAeVyL0CZs-TXAfcJc_hDJoIHKkdcE7iNCnWH2DIEVxKT0OjDfHTSREKjWBxoCAuYQAvD_BwE