Sysmex Inostics announces first results of tissue-independent liquid biopsy for early stage breast cancer mutation characterization and monitoring using ultra-sensitive SafeSEQ technology

Hamburg, Germany and Baltimore, Maryland (ots) - New data presented by Dr. Ben
Ho Park, Professor of Medicine and Director of Precision Oncology at Vanderbilt
University and colleagues at the recent San Antonio Breast Cancer Symposium
(SABCS) in San Antonio, Texas demonstrated a potential utility for monitoring
tumor-specific mutations (TSMs) in the circulation of early stage
triple-negative breast cancer patients. The investigators utilized Sysmex
Inostics' highly sensitive SafeSEQ technology to detect rare variants down to
0.05% mutant allele fraction (MAF) to explore the rate of detection of ctDNA
variants independent of the need for a tissue biopsy.

This initial data was generated as a pilot investigation as part of the PREDICT
DNA trial ("Pathologic Response Evaluation and Detection In Circulating Tumor
DNA"), the first prospective, multi-center study designed to verify cell-free
circulating tumor DNA (ctDNA) as a biomarker for treatment response and
recurrence in early stage breast cancer, with the primary aim of determining the
negative predictive value of a negative ctDNA result after neoadjuvant therapy
for the achievement of pathologic complete response. Essentially the trial
measures whether patients who undergo neoadjuvant chemotherapy to treat tumors
prior to surgery still have ctDNA in their blood after the therapy but before
surgery. Dr. Park shared "We give chemotherapy to early stage breast cancer
patients and probably 70 percent of those patients don't need it, but we
generally can't define who has micro-metastatic disease and who doesn't." The
PREDICT DNA trial is aiming to understand whether ultrasensitive next-generation
sequencing with a SafeSEQ targeted cancer mutation panel can identify and
monitor ctDNA of early-stage breast cancer patients to more precisely administer
neoadjuvant therapy and surgery in newly diagnosed patients.

A total of 228 patients with Stage II and III triple-negative or HER2-positive
breast cancer have been enrolled at 22 sites, of which 77 with matched pre- and
post-neoadjuvant therapy samples were available at the time of the pilot study.
Using SafeSEQ, tumor-specific mutations were identified in 48% (37/77) of the
pre therapy samples, of which 89% had detectable plasma TP53 mutations, 11% had
PIK3CA mutations, and 11% had co-occurring TP53 and PIK3CA mutations. A cohort
of patient plasma specimens underwent orthogonal testing with OncoBEAM digital
PCR technology, with 100% concordance of results with SafeSEQ.

The authors of the study concluded that SafeSEQ's ultrasensitive detection of
ctDNA has 'significant clinical implications as an affordable and non-invasive
first-pass assay in patients with sparse tumor biopsy tissue'. This preliminary
data also demonstrates clinical feasibility of identifying tumor-specific
mutations in individuals using minimally-invasive liquid biopsy before
neoadjuvant treatment for personalized disease response monitoring without the
need for biopsy tissue for NGS analysis.

"There is a paramount need for prospective studies using liquid biopsy" said Dr.
Ben Ho Park, Professor of Medicine and Director of Precision Oncology,
Vanderbilt University Medical Center. "These exciting preliminary results from
the PREDICT DNA Trial represent an important first step in understanding the
role of liquid biopsy testing for the management of early stage breast cancer
and helping the medical community map out a path to make precision medicine a
reality for patients across the continuum of care."

Presentation Details: Saturday 14 December 2019 7am - 9am, Poster Session 6,
P6-10-05

Hunter, N. et al (2019) Pathologic Response Evaluation and Detection In
Circulating Tumor DNA (PREDICT DNA): Initial results piloting a tissue-biopsy
independent method of identifying and monitoring tumor-specific mutations in
early stage breast cancer: TBCRC 040 Presented at the San Antonio Breast Cancer
Symposium in San Antonio, Texas. ClinicalTrials.gov Identifier: NCT02743910

This work supported by the Translational Breast Cancer Research Consortium.

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 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 www.sysmex-inostics.com or
email info@sysmex-inostics.com.

Contact:

Contact:

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

Additional content: https://www.presseportal.de/pm/114536/4470253
OTS: Sysmex Inostics GmbH

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