Sysmex Inostics' OncoBEAM(TM) liquid biopsy technology demonstrates utility for clinical management of melanoma patients undergoing treatment with targeted therapy and immune checkpoint inhibitors

Hamburg, Germany (ots) - Sysmex Inostics, a pioneer in blood-based
circulating tumor DNA (ctDNA) analysis and molecular diagnostics for
oncology, is pleased to announce publication of a study in the
Journal of Molecular Oncology highlighting the important clinical
value of blood-based ctDNA mutation testing to complement
standard-of-care management of patients with advanced melanoma.
Investigators at Johns Hopkins University School of Medicine utilized
Sysmex Inostics' CLIA-certified OncoBEAM liquid biopsy tests to
examine the clinical utility of ctDNA measurements as an adjunct to
radiographic imaging for monitoring disease activity and to inform
clinical decision-making in patients undergoing treatment with
targeted therapy or immune checkpoint inhibitors. This investigation
represents one of the first to provide direct evidence of the impact
of ctDNA on interpretation of radiographic data and clinical outcomes
and furthers the extensive clinical validation of OncoBEAM, which is
the current gold-standard for liquid biopsy testing.

Advanced melanoma is challenging to treat, with overall 5-year
survival rates of around 20%, meaning only 1 in 5 patients will
survive for 5 years after diagnosis. Although current targeted and
immune-based therapies have demonstrated remarkable anti-tumor
ef?cacy in patients with advanced melanoma, numerous challenges exist
towards ensuring patients receive the most highly-effective
treatment. Currently, tissue testing is preferred for detection of
actionable mutations; however, it is known that false negative calls
may result when the tissue sample testing fails to capture genomic
profiles of interest, sometimes due to molecular heterogeneity.
Additionally, radiographic imaging, which includes CT and PET scans,
is the current standard-of-care for evaluation of therapeutic
response. However, several clinical research groups have previously
demonstrated difficulties associated with interpreting imaging in
patients undergoing treatment with immunotherapies as tumors may
appear to grow before eventually regressing. Furthermore,
microscopic occult disease that can drive tumor progression may go
undetected by even the most sensitive radiographic techniques.
Together, the result is that current standard-of-care practices may,
in some cases, fail to yield vital clinical information.

With these clinical challenges in mind, investigators at the Johns
Hopkins University School of Medicine led by Drs. Evan Lipson,
Medical Oncology, and Steven Rowe, Radiological Sciences, sought to
examine the performance of OncoBEAM by comparing the agreement of
plasma mutation testing with that of standard-of-care tumor tissue
mutation testing. All plasma mutation analysis was performed with the
OncoBEAM BRAF and NRAS assay validated in Sysmex Inostics'
CLIA-certified laboratory (Baltimore, MD). Fifty-five patients were
evaluated, with OncoBEAM demonstrating a sensitivity and specificity
for NRAS and BRAF mutation detection in plasma of 86.7% and 100%,
respectively. In addition to high overall agreement with tissue
testing, the clinical value of ctDNA was underscored by two patients
for whom tissue analysis did not detect a BRAF V600E mutation that
was successfully detected in plasma. Based on the ctDNA findings,
both patients were treated with BRAF/MEK-targeted therapy; each
patient experienced a partial response to treatment (RECIST v1.1).

Drs. Lipson and Rowe also investigated the clinical utility of
ctDNA to assist with interpretation of radiographic data in patients
with advanced melanoma receiving either targeted therapy or immune
checkpoint inhibitor therapy. ctDNA levels were serially monitored in
30 patients and results were correlated with interpretation of
radiographic imaging. The investigators discovered that in a subset
of those patients, ctDNA signaled disease progression an average of
21 weeks earlier than did radiographic imaging. These results have
important implications for the clinical management of patients
receiving immunotherapy and demonstrate the value of performing ctDNA
testing for better resolution of tumor activity when performed
alongside routine imaging and clinical assessments.

About OncoBEAM(TM)

Sysmex Inostics' highly sensitive OncoBEAM(TM) services allow for
molecular genetic analysis of cell-free tumor DNA from blood or
plasma, delivering an individualized approach to complement treatment
decision-making in oncology. Based on the highly sensitive BEAMing
technology developed at the Johns Hopkins University School of
Medicine, OncoBEAM(TM) testing is able to provide multiplex hotspot
mutation analysis for the accurate and reliable detection of rare
mutant molecules of tumor DNA from blood samples of patients with
cancer. Due to its minimally invasive nature, OncoBEAM(TM) delivers
new possibilities for cancer management while minimizing costs and
risks inherent with tissue biopsies. The OncoBEAM(TM) assays target a
wide variety of clinically actionable genetic mutations in various
cancers like melanoma, colorectal, breast and lung cancer, delivering
information in real-time to support therapy selection, detection of
emergent mutations and assessment of drug response. In the US,
OncoBEAM(TM) tests are available as GCP and CLIA services.
OncoBEAM(TM) RAS CRC CE IVD kit is available in EU.

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a
molecular diagnostic company whose core competency is mutation
detection utilizing highly sensitive technologies such as BEAMing and
Plasma Safe-Sequencing. Sysmex Inostics is a trusted partner to
leading pharmaceutical companies, advancing their efforts to bring
the most effective personalized cancer therapies to global markets.

With BEAMing and Plasma Safe-Sequencing (SafeSeq) being some of
the most sensitive technologies available today for the detection of
tumor-specific somatic mutations in blood samples, Sysmex Inostics'
services are readily available to support clinical trials and
research in oncology. In addition, OncoBEAM(TM) tests are available
today through CLIA-certified laboratory for routine clinical
analysis.

Sysmex Inostics' headquarters and GCP Service Laboratory are
located in Hamburg Germany; Sysmex Inostics' Commercial Offices and
CLIA-certified and GCP Clinical Laboratory is located in Baltimore,
Maryland. For more information on Plasma Safe-Sequencing and
OncoBEAM(TM) blood testing, please visit www.sysmex-inostics.com or
email info@sysmex-inostics.com.

Contact:
Sysmex Inostics
Press Release
Phone +49(0)40-3259070
Mail info@sysmex-Inostics.com

Original-Content von: Sysmex Inostics GmbH, übermittelt durch news aktuell