Liquid Biopsy performance comparison of Sysmex Inostics OncoBEAM RAS CRC and BioCartis Idylla ctKRAS testing published in Scientific Reports (Nature Journal)

Hamburg, Germany (ots) - Sysmex Inostics, a global leader in blood
based circulating tumor DNA (ctDNA) analysis and molecular
diagnostics for oncology, today announces publication of a study
comparing the performance of plasma RAS mutation detection by two
commercial liquid biopsy testing platforms, the OncoBEAM(TM) RAS CRC
and the Idylla ctKRAS Mutation Test from the BioCartis Group NV.
Preliminary results were previously presented at the American Society
of Clinical Oncology's Gastrointestinal Cancer Symposium ASCO GI in
2018.

This study was conducted by a group of four leading Spanish
hospitals that perform liquid biopsy testing in routine colorectal
cancer (CRC) clinical practice. They found significant differences in
clinical sensitivity for KRAS mutation detection between enhanced
digital PCR-based OncoBEAM and real-time PCR Idylla technology. The
investigators identified a "gray zone" below 1% Mutant Allele
Fraction (MAF) where OncoBEAM reliably detected KRAS mutations across
116 patient plasma samples, but Idylla did not.

Notably of the 63 samples where the measured MAF was above 0.1%
but below 1.0%, OncoBEAM detected 63/63 (100.0% sensitivity) whereas
Idylla detected 41/63 (65.1%), with a significant p-value of <0.0001.
In the 16 samples where the measured MAF was below 0.1%, OncoBEAM
detected 16/16 (100% sensitivity) whereas Idylla detected 7/16
(43.8%), with a significant p-value of 0.0077. The OncoBEAM RAS CRC
test has an analytical sensitivity down to 0.03% MAF. Of the 116
clinical samples tested by both platforms, a majority of them (79/116
or 68.1%) had minor allele frequencies of less than 1%.

"These results show an important 'gray area' where real-time PCR
based assays like Idylla show reduced KRAS mutation detection
accuracy in plasma as compared to tissue testing and digital PCR
testing with OncoBEAM", commented Dr. Ana Vivancos, Principal
Investigator, Cancer Genomics Group at Vall d'Hebron Institute of
Oncology (VHIO, Barcelona Spain). "Precise and sensitive tests for
targeted therapy are crucial, in particular for liquid biopsy, and
this should serve as a reminder that not all assays are equivalent.
Clinicians and translational scientists need to be aware that assays
lacking appropriate sensitivity may result in diminished detection of
certain mutations and, hence, impact the treatment decision."

The publication, titled "Comparison of the Clinical Sensitivity of
the Idylla Platform and the OncoBEAM RAS CRC Assay for KRAS Mutation
Detection in Liquid Biopsy Samples", was published in Scientific
Reports (a Nature Journal publication) June 20, 2019 by Ana Vivancos
and Eduardo Diaz-Rubio et al. PMID: 31222012
(https://www.ncbi.nlm.nih.gov/pubmed/31222012)
DOI:10.1038/s41598-019-45616-y
(https://doi.org/10.1038/s41598-019-45616-y)

About Sysmex Inostics

Sysmex Inostics, a subsidiary of Sysmex Corporation, is a
molecular diagnostic company that is a pioneer in blood-based
cell-free tumor DNA (ctDNA) mutation detection in oncology utilizing
highly sensitive technologies such as OncoBEAM(TM) (digital PCR) and
SafeSEQ (NGS). These technologies were initially developed by experts
at the Johns Hopkins School of Medicine over a decade ago and this
deep expertise in ctDNA analysis extends to the core of Sysmex
Inostics' capabilities for technology development and implementation.

With more than 10 years' of experience in liquid biopsy Sysmex
Inostics is a trusted partner to leading pharmaceutical companies,
advancing their efforts to bring the most effective personalized
cancer therapies to global markets, from discovery through companion
diagnostics.

Sysmex Inostics' OncoBEAM(TM) and SafeSEQ services are readily
available to support clinical trials and research in oncology. In
addition, OncoBEAM(TM) tests are available through a CLIA-certified
laboratory for routine clinical analysis as well as distributed kit
products in the EU.

Sysmex Inostics' headquarters and GCP Service Laboratory are
located in Hamburg Germany; Sysmex Inostics' CLIA-certified and GCP
Clinical Laboratory is located in Baltimore, Maryland. For more
information refer to 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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