Sysmex Inostics Presents Data at AACR Demonstrating SafeSEQ NGS Liquid Biopsy Delivers Equivalent Performance to the Extensively Clinically Validated OncoBEAM dPCR Technology for NSCLC Patients

Baltimore, MD, USA (ots) - Sysmex Inostics, Inc., a global leader of the liquid
biopsy revolution for oncology, is presenting the poster "Clinical evaluation of
NGS-based liquid biopsy testing in non-small cell lung cancer (NSCLC) patients"
at the 112th Annual Meeting of the American Association for Cancer Research on
April 10, 2021, from 8:30 AM - 11:59 PM Eastern Daylight Time (EDT).

In a recent collaborative study, Johns Hopkins University School of Medicine and
Sysmex Inostics' researchers showed that the next-generation sequencing
(NGS)-based liquid biopsy SafeSEQ NSCLC panel delivers equivalent performance
with broader genomic coverage than testing with OncoBEAM(TM) digital PCR (dPCR).
OncoBEAM technology is widely considered a gold standard for high sensitivity
molecular testing and continues to be one of the most sensitive dPCR approaches.

SafeSEQ technology demonstrates ultra-sensitive detection of low-frequency
mutations, with a calling threshold of 5 mutant molecules (0.025% mutant allele
frequency [MAF]) from whole blood. Concordance analysis of SafeSEQ and OncoBEAM
results demonstrated an overall percent agreement of 99.6% for detection of
mutations in EGFR, KRAS, and BRAF (>0.1% MAF).

The 5-year survival rate for metastatic NSCLC (mNSCLC) patients is relatively
low; however, it has improved with the advent of targeted therapies and uptake
of circulating tumor DNA (ctDNA) based technologies in recent years. In
groundbreaking NSCLC clinical trials AURA and TIGER-X, patients positive for
EGFR T790M detected in plasma by OncoBEAM had equivalent outcomes to patients
positive by a tissue-based assay when treated with third-generation epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), which have
demonstrated potent activity against first-line EGFR TKI resistance mediated by
EGFR T790M.

SafeSEQ NSCLC testing delivers broader genomic coverage than OncoBEAM, with the
same ultra-sensitive detection for rare mutant molecules. Therefore, SafeSEQ is
better suited to identify molecular mediators of treatment resistance to improve
therapeutic strategies, delivering high-resolution monitoring of therapeutic
efficacy, and enabling minimum residual disease (MRD) detection and recurrence
surveillance for NSCLC patients.

Poster number LB053, "Clinical evaluation of NGS-based liquid biopsy genotyping
in non-small cell lung cancer (NSCLC) patients," presented by Hillary Sloane,
Associate Director of Medical & Scientific Affairs at Sysmex Inostics, will be
available Saturday, April 10, 2021, from 8:30 AM - 11:59 PM EDT during the 112th
Annual Meeting of the American Association for Cancer Research during Session
PO.CL11.04 - Liquid Biopsies: Circulating DNA.

AURA Trial: Oxnard, GR, et al. J Clin Oncol 2016 , 34 (28), 3375-82.

TIGER-X Trial: Karlovich, C, et al. Clin Cancer Res 2016 , 22 (10), 2386-95.

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 SafeSEQ (NGS), and OncoBEAM(TM) (digital
PCR).

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

Sysmex Inostics' SafeSEQ and OncoBEAM 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]

Press Contact

Tracy Vandenbroek
Sysmex Inostics
Director, Marketing
mailto:[e-mail]
+1.512.791.2899

Additional content: http://presseportal.de/pm/114536/4885598
OTS: Sysmex Inostics GmbH