Sysmex Inostics OncoBEAM(TM) circulating tumor DNA technology demonstrates superior response prediction for advanced pancreatic cancer over standard-of-care protein biomarkers

Hamburg, Germany (ots) - Recent data published in Annals of
Oncology (https://academic.oup.com/annonc/advance-article/doi/10.1093
/annonc/mdy417/5139593) from a study conducted by Sysmex Inostics and
University of Munich indicate that circulating tumor DNA (ctDNA) may
offer clinicians higher-resolution information for response
prediction and therapy monitoring for advanced pancreatic cancer
patients compared to current established protein biomarkers. Sysmex
Inostics' gold-standard OncoBEAM(TM) liquid biopsy technology was
used for highly sensitive, quantitative determination of ctDNA levels
in blood samples serially collected from advanced pancreatic cancer
patients receiving chemotherapy. Not only was the presence of
detectable ctDNA in the blood significantly correlated with adverse
clinical outcomes, but changes in ctDNA levels in response to therapy
were both more pronounced and rapid than changes in established
protein biomarkers, suggesting potential clinical benefit of serial
ctDNA testing for improved patient care.

The survival rate for advanced pancreatic cancer remains poor
despite intensified therapeutic regimens, with median overall
survival still less than one year. While development of novel
therapies would be accelerated by robust predictive and prognostic
biomarkers, thus far carbohydrate antigen 19-9 (CA 19-9), which was
originally characterized in 1979, is the only biomarker recommended
for routine clinical use. However, given recent advancements in
highly sensitive liquid biopsy as well as increased understanding of
the relationship between ctDNA and disease progression, ctDNA testing
may offer advantages over CA 19-9 and other protein biomarkers such
as carcinoembryonic antigen (CEA) and cytokeratin-19 fragments (CYFRA
21-1). While protein biomarkers are not tumor-specific and can be
elevated in patients without cancer, ctDNA delivers unique
specificity as a real-time tumor biomarker. Because mutations
affecting the KRAS gene are known to be present in approximately 90%
of pancreatic cancers, highly sensitive detection focused on KRAS is
ideal for investigation of the predictive and prognostic power of
ctDNA in pancreatic cancer.

Sysmex Inostics's OncoBEAM(TM) platform, which is based on BEAMing
technology developed at Johns Hopkins University and is the current
gold-standard for highly sensitive detection of clinically-relevant
mutations, was used in this study to determine ctDNA levels in blood
specimens collected from advanced pancreatic cancer patients. Out of
28 patients with metastatic disease, 22 (79%) had a baseline KRAS
mutation detectable in the blood, which was significantly correlated
with both adverse progression-free survival (PFS) as well as overall
survival (OS). Additionally, when serial blood samples were evaluated
up until tumor progression, an increase in KRAS-mutant ctDNA
indicated disease progression with a sensitivity of 83%, and no false
positives (100% specificity). By contrast, CEA demonstrated only 52%
sensitivity and 86% specificity for identification of disease
progression, while CA 19-9 showed inferior sensitivity across
multiple different diagnostic cut-offs.

These results suggest utility of ctDNA for evaluation of
therapeutic response for pancreatic cancer that exceeds the
resolution of current established protein-based markers. The ability
to correlate changes in ctDNA with clinical response depends heavily
on the capabilities of the technology used. Importantly, the breadth
of dynamic range of ctDNA discrimination and especially accuracy at
the lower limit of detection are key and are both native features of
BEAMing. As Dr. Stefan Holdenrieder, senior investigator for the
study commented, "The extremely high sensitivity of OncoBEAM(TM) is
especially useful for serial testing of mutations which may be
initially present at very low levels in the blood and may also
decrease in frequency in response to therapeutic intervention.
Accurate detection well below 1% mutant allele frequency, and even
below 0.1%, allows the most thorough evaluation of disease response
by minimizing the chances of false negative calls." Dr. Holdenrieder
added, "As evidence continues to accumulate supporting the
integration of ctDNA into routine clinical practice for therapeutic
monitoring and response prediction, use of a highly sensitive test
such as OncoBEAM(TM) will then translate directly into the most
reliable results for patients."

Publication Details

Kruger, S. et al. Repeated mutKRAS ctDNA measurements represent a
novel and promising tool for early response prediction and therapy
monitoring in advanced pancreatic cancer. Ann Oncol. Off. J. Eur.
Soc. Med. Oncol. (2018). https://doi.org/10.1093/annonc/mdy417

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 minimal-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 a 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

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