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

Joins Foundation for the National Institutes of Health Biomarkers Consortium 


Baltimore, MD, May 24, 2022 – 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

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.

Contact:
Tracy Vandenbroek, Senior Director, Marketing & Business Strategy, Sysmex Inostics
+1.512.791.2899
vandenbroek.tracy@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 

New Ultra-Sensitive Leukemia Blood Test Delivered by Sysmex Inostics

New Tool for Detection of Minimal Residual Disease in Acute Myeloid Leukemia to Better Help in Fight Against Cancer

Baltimore, MD, October 20, 2021 – Sysmex Inostics has developed a new CLIA-validated liquid biopsy test for the detection of Minimal Residual Disease (MRD) in Acute Myeloid Leukemia (AML). A global leader and pioneer in blood-based, ultra-sensitive molecular testing for oncology, the company’s new test uses a targeted Next Generation Sequencing (NGS) panel.

“The new test, AML-MRD-SEQ, offers clinical trial sponsors, and eventually physicians and patients, an early signal for the presence of cancer cells following initial therapy. This new liquid biopsy solution is a major step in developing treatment strategies to support the fight against a devastating disease,” said Shinichi Sato, CEO of Sysmex Inostics, Inc.

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

Previous generations of AML MRD tests were only able to detect a limited number of mutations that have an established therapeutic indication. AML-MRD-SEQ offers a more expansive panel covering 68 regions across 20 genes, including established MRD markers such as NPM1, and demonstrating significant potential for use as an investigational tool for other markers with prognostic values that are not yet well-established. The new highly sensitive AML-MRD-SEQ test with broader genomic coverage offers the opportunity for early intervention and clinical trial enrollment.

“Sysmex Inostics’ mission is to develop new innovative tools and expand partnerships with top-tier global biopharmaceutical companies to further advance drug development and treatments for the benefit of oncology patients worldwide,” Sato concluded.

AML-MRD-SEQ offers reliable detection of molecular MRD with 50 to 100 times greater sensitivity versus other currently available NGS pan-heme tests.1,2 Such ultra-sensitive detection of low-level mutant molecules allows clinical trial sponsors to execute on clinical development timelines more efficiently.

AML is one of the deadliest blood cancers, resulting in more than 10,000 lives lost in the U.S. each year.3 Because AML relapses usually result in a poor prognosis, it is necessary to test patients for MRD after initial treatment as a prognostic indicator of therapeutic effectiveness and relapse risk. Applying Sysmex Inostics’ ultra-sensitive liquid biopsy NGS technology, Plasma-Safe-SeqS, to the detection of gene mutations associated with AML MRD enables accelerated clinical development timelines, cost savings, and improved outcomes throughout the clinical trial process.

A recent market research report states that the liquid biopsy market is estimated to achieve an annual growth rate of more than 35% over the next few years, reaching $4 billion by 2024.4 The analysis notes that an increasing focus on personalized medicine for cancer care is driving the tremendous growth.

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 (<0.05% MAF) with a high degree of specificity. Focused and flexible genomic coverage allows for superior sensitivity and reduced costs.

As pioneers in 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 Inostic’s 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.

Contact:
Tracy Vandenbroek
Director, Marketing
Sysmex Inostics
+1.512.791.2899
vandenbroek.tracy@sysmex-inostics.com

References:

  1. https://www.illumina.com/content/dam/illumina-marketing/documents/products/datasheets/datasheet-trusight-myeloid.pdf
  2. https://assets.ctfassets.net/w98cd481qyp0/42r1cTE8VR4137CaHrsaen/baf91080cb3d78a52ada10c6358fa130/FoundationOne_Heme_Technical_Specifications.pdf
  3. https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics
  4. Global Liquid Biopsy Market 2020-2024 (Sept. 2020) https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics