Sysmex Inostics' updated SafeSEQ Breast Cancer Panel advances novel clinical uses of ctDNA through quantitative testing

Baltimore, Maryland (ots) - Building on the ultra-high sensitivity SafeSEQ
Breast Cancer Panel circulating tumor DNA (ctDNA) test launched at the American
Association of Cancer Research 2019 annual meeting (https://www.prnewswire.com/n
ews-releases/sysmex-inostics-safeseq-erher2--breast-cancer-panel-demonstrates-eq
uivalent-sensitivity-to-oncobeam-enhanced-digital-pcr-technology-for-detection-o
f-mutations-in-circulating-tumor-dna-300856938.html) , Sysmex Inostics has
updated the test to provide additional key information for investigation of the
validity of ctDNA for molecular monitoring and recurrence surveillance for
breast cancer patients who are receiving novel therapies.

In addition to a high detection rate even for patients with very low frequency
mutations, the SafeSEQ Breast Cancer Panel has now also demonstrated the ability
to delineate true changes in the level of ctDNA from random sampling or
technical variation. This is in contrast to other liquid biopsy methods which
report mutations detected along with the ratio of mutant molecules to wildtype
molecules (mutant allele frequency, MAF), but are unable to relate changes in
MAF to changes in the disease status of the patient with confidence. For
instance, clinical data presented at San Antonio Breast Cancer Symposium ( SABCS
(https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-6) ) demonstrated
the importance of accurate detection of ctDNA with SafeSEQ testing to monitor
tumor response in breast cancer patients receiving neoadjuvant treatment.

As a highly refined clinical development diagnostic, the SafeSEQ breast cancer
panel has demonstrated exquisite sensitivity for detecting mutations in ESR1,
which are known to arise in patients with estrogen receptor-positive breast
cancer who have progressed on adjuvant hormone therapy. Extensive ESR1 ctDNA
testing by Sysmex Inostics' OncoBEAM enhanced digital PCR has shown that these
mutations occur at very low frequencies in circulation. Patients who are
receiving an investigational ESR1 -directed therapy as part of a clinical trial
may exhibit an ESR1 mutation well below 1% MAF at baseline which could then
decrease further, sometimes below 0.1% MAF, several months after initiation of
therapy. Using a traditional qualitative ctDNA next generation sequencing-based
test would not only make detection of these low-frequency mutations difficult,
but it would also not be possible to determine whether this reduction in MAF
represents a true decrease in ctDNA that could reflect a clinical response. This
is because the reduction in MAF may result from an increase in wildtype DNA
rather than a decrease in tumor-derived DNA, and the magnitude of change in MAF
may be within the range of random variation that is inherent to the assay.
Quantitative ctDNA detection is also important for other clinical applications
such as monitoring tumor response for patients receiving neoadjuvant treatment
as illustrated by SafeSEQ data presented at the recent San Antonio Breast Cancer
Symposium, Poster P6-10-05
(https://www.sabcs.org/Program/Poster-Sessions/Poster-Session-6) .

The updated SafeSEQ Breast Cancer Panel can overcome these challenges by
determining whether the change in the absolute number of ESR1 mutant molecules
detected at each timepoint, irrespective of the wildtype background, is
sufficient to suggest a true biological cause such as a clinical response. This
ability for true quantitative mutation detection is based on a rigorous
linearity validation study and is especially important given the increasing
interest in ctDNA-based monitoring and surveillance to support rapid
advancements in therapies for breast cancer patients.

"Without quantitatively measuring ctDNA in a way that is specific for the
patient's disease and instead employing qualitative methods based on mutant
allele frequency that have traditionally been used for tissue analysis, you're
neglecting some of the unique aspects of ctDNA testing that can make it an
extremely powerful tool for clinical development," noted Matt Ryder, Sysmex's
Associate Director of Biomarkers & Companion Diagnostics. "We are confident that
the SafeSEQ Breast Cancer Panel is now one of the most informative tests
available to support development of novel therapies for breast cancer, and we
look forward to helping our pharma partners explore the clinical validity of
ctDNA-based therapeutic monitoring and recurrence surveillance."

The updated SafeSEQ Breast Cancer Panel is available now for use as a clinical
trial assay in Sysmex Inostics' Baltimore-based CLIA laboratory.

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 biopharmaceutical 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 and Asia Pacific.

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
http://www.sysmex-inostics.com/ or email mailto:info@sysmex-inostics.com .

Contact:

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

Additional content: https://www.presseportal.de/pm/114536/4542532
OTS: Sysmex Inostics GmbH

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