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, MD (ots) - 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(TM) enhanced
digital PCR technology has been used to monitor the levels of IDH mutations
present in AML patients receiving targeted therapies. OncoBEAM(TM) 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 (https://ash.confex.com/ash/2020/webprogram/Paper140016.html) "
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 Annual Meeting
(https://www.hematology.org/meetings/annual-meeting) during the Acute Myeloid
Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and
Prognosis poster session number 617.

About Sysmex Inostics

Sysmex Inostics, a Sysmex Corporation subsidiary, empowers discoveries in
oncology by providing investigators cost-effective and ultra-sensitive
quantitative liquid biopsy solutions, OncoBEAM(TM) (digital PCR), and SafeSEQ
(NGS).

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 cell-free 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 develop therapeutics
to extend lives and companion diagnostics to monitor progression, identify
targetable resistance alterations, and detect minimal residual disease (MRD).

Sysmex Inostics' OncoBEAM(TM) and SafeSEQ services are readily available and
customizable to support clinical trials and research in oncology. OncoBEAM(TM)
tests are available through a CLIA-certified laboratory for routine clinical
analysis and distributed kit products in the E.U.

Sysmex Inostics' European headquarters for research & development GCP laboratory
testing are located in Hamburg, Germany; Sysmex Inostics' U.S. headquarters and
CLIA-certified and GCP Clinical Laboratory is located in Baltimore, Maryland.

For more information, refer to http://www.sysmex-inostics.com or email
mailto:[e-mail]

Contact:

Sysmex Inostics
Press Release
Phone: [phone]
Mail: mailto:[e-mail]

Additional content: http://presseportal.de/pm/114536/4782987
OTS: Sysmex Inostics GmbH