Sysmex Inostics and Oxford Gene Technology plasma and tissue sequencing show clearance of ctDNA correlates with pathologic complete response in breast cancer patients during neoadjuvant treatment

Hamburg, Germany and Baltimore, Maryland (ots) - Pathologist Dr. Vincente Peg of
the Vall d´Hebron University Hospital (Barcelona Spain) and colleagues have
presented a correlation between the clearance of circulating tumor DNA (ctDNA)
in HER2-positive or triple-negative breast cancer patients undergoing
neoadjuvant treatment with a clinical/pathologic complete response at the
American Association for Cancer Research (AACR) Advances in Liquid Biopsies
conference held in Miami, Florida (USA), January 13-16, 2020. The researchers
utilized both a SureSeq(TM) NGS cancer gene enrichment panel (Oxford Gene
Technology, a Sysmex Group Company) for identifying lead mutations from breast
cancer FFPE tissue, and Sysmex Inostics' SafeSEQ personalized liquid biopsy
platform for patient-specific longitudinal analysis of plasma ctDNA.

Neoadjuvant therapy to reduce tumor size prior to surgical resection is common
in the treatment of early stage breast cancer. However, there exists an unmet
clinical need to distinguish those patients with residual disease after
neoadjuvant therapy (NAT) from those who achieved complete response in order to
better understand which patients are appropriately suited for surgery.
Researchers from Vall d´Hebron deployed SureSeq NGS testing to identify driver
mutations in breast cancer biopsy tissue of 29 patients with early stage
disease. The mutations detected with SureSeq were subsequently followed in the
plasma of patients with the SafeSEQ ultrasensitive personalized ctDNA platform
to complement radiographic assessment and provide more detailed information on
an individual's response to NAT.

Of 29 Stage II and Stage III triple-negative and HER2-positive breast cancer
patients examined in the study, 20 (69%) had TP53 or PIK3CA tissue mutations
identified by SureSeq with 17 out of 20 (85%) patients having detectable
mutations with SafeSEQ in plasma samples prior to initiation of NAT.
Longitudinal plasma analysis conducted at treatment mid-point and post-treatment
immediately prior to surgery demonstrated the absence of ctDNA following NAT was
observed in all patients (12/12) showing a complete clinical response. However,
ctDNA was detected in 3 out of 5 (60%) of patients who did not achieve complete
clinical response suggesting that ctDNA testing - alongside of imaging - is an
important clinical parameter to consider when determining complete response to
neoadjuvant treatment.

"This study addresses the unmet need to de-escalate surgery in patients with no
sign of disease." Dr. Vicente Peg commented. "How can we avoid surgically
removing something that is just not there? Circulating tumor DNA by itself is
able to detect 85% of patients that achieve pathologic complete response;
however, when combined with imaging we can identify 100% of patients. These
findings are an important first step to showing that we can accurately identify
those patients who may avoid unnecessary surgery."

Reference: Ciriaco, N., Zamora, E. and Peg, V. et al. AACR Advances in Liquid
Biopsy Conference 2020 Poster session B January 15, 2020. Clearance of ctDNA in
triple-negative and HER2-positive breast cancer patients during neoadjuvant
treatment is correlated with pathological complete responses, Poster B63.

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 (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/114536/4504537
OTS: Sysmex Inostics GmbH

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