Study demonstrating Biocartis' BRAF liquid biopsy assay as good as more invasive tissue tests published in renowned journal of American Association for Cancer Research
(Thomson Reuters ONE) -
PRESS RELEASE
Study demonstrating Biocartis' BRAF liquid biopsy assay
is as good as more invasive tissue tests published in renowned journal of
American Association for Cancer Research
Test can predict therapy response over the course of the cancer treatment
Mechelen, Belgium, 23 May 2016 - Biocartis Group NV ('Biocartis'), an innovative
molecular diagnostics company (Euronext Brussels: BCART), today announces the
recent publication of a research study[1] demonstrating that testing for BRAF
V600 mutations in blood plasma is as good as more invasive tissue tests[2]. The
study by Dr. Filip Janku, PhD, assistant professor of Investigational Cancer
Therapeutics at MD Anderson Cancer Center (Houston, US), was published in
Molecular Cancer Therapeutics, a journal of the American Association for Cancer
Research (AACR), the world's largest professional association related to cancer
research. The press release of AACR announcing the publication of this study can
be found here.
In this study, Dr. Janku and his team demonstrated that testing for BRAF V600
mutations in circulating tumour (ct)DNA from plasma, using Biocartis' Idylla(TM)
ctBRAF Mutation Assay[3], was concordant with standard tests using tumour tissue
samples and could generate results in an unprecedented short turnaround time of
90 minutes. The study confirms that the Idylla(TM) ctBRAF Mutation Assay can act
as a faster and minimally invasive substitute for invasive tissue biopsy testing
in advanced cancers such as melanoma or colorectal cancers, which underlines
that the test is perfectly suited for treatment monitoring.
Research over the last few years has shown that fragments of tumour DNA are shed
into the blood from primary tumours or metastatic sites[4]. These circulating
DNA fragments can be used for diagnostic purposes, such as providing molecular
information for treatment selection, or for monitoring disease progression in
patients undergoing treatment. According to J.P. Morgan, the global market of
liquid biopsy tests is estimated to reach $20 billion by 2020.
In the current study, plasma samples collected from 160 patients with a range of
advanced cancers with known BRAF V600 mutation status were tested with the
Idylla(TM) ctBRAF Mutation Assay(3). Dr Janku and his team found that the test
had 88 percent concordance with the results from the tissue tests that used
solid, paraffin-embedded tissues, in samples collected at baseline. The
concordance increased to 90 percent when results from samples collected at any
time point during the course of the treatment were compared. The researchers
also found that the amount of BRAF V600 mutant circulating tumour (ct)DNA, as
detected by the Idylla(TM) platform(3), was predictive of overall survival of
the patients: in patients with a BRAF-mutant circulating tumor (ct)DNA
percentage of 2 or less, overall survival was 10.7 months, compared with 4.4
months in those who had more than 2 percent of BRAF V600 mutations in their
samples.
Geert Maertens, Chief Scientific Officer of Biocartis, stated: "We are very
excited about this AACR publication. It's a great recognition of the outstanding
performance of Biocartis' first fully automated liquid biopsy assay, the
Idylla(TM) ctBRAF Mutation Assay(3). The study demonstrates that this test can
act as a faster and minimally invasive test, complementary to tissue biopsy
testing in advanced cancers such as melanoma or colorectal cancers. Another
important outcome was the connection between the level of BRAF V600 mutations
measured with the test, and the time to treatment failure (TTF), which
underlines the test is perfectly suited for treatment monitoring."
Dr. Filip Janku, MD, PhD at MD Anderson Cancer Center, Houston, US, added: "We
demonstrated that testing for BRAF V600 mutations in plasma circulating tumor
(ct)DNA using the Idylla(TM) ctBRAF Mutation Assay(3) is feasible, has
comparable sensitivity and specificity to other Polymerase Chain Reaction (PCR)
or next-generation sequencing methods, and has an unprecedented short turnaround
time. This study now confirms that the Idylla(TM) ctBRAF Mutation Assay(3) can
act as a faster and less invasive substitute for tissue biopsy testing in
advanced cancers such as melanoma or colorectal cancers, and the test has unique
features to monitor treatment efficiency and predict survival of patients."
The performance of the Idylla(TM) ctBRAF Mutation Assay(3) of Biocartis was also
confirmed in another recent study[5] by Prof. Bart Neyns (Head of Medical
Oncology, University Hospital Brussels) and his team. Published in the Journal
of Translational Medicine, this study also concludes that the quantitative
analysis of BRAF V600 mutant circulating tumour (ct)DNA in plasma has unique
potential as a tool for therapeutic monitoring in metastatic melanoma patients
treated with BRAF/MEK inhibitors.
Over the coming years, Biocartis plans to develop a range of liquid biopsy
tests, alongside the ongoing development of tissue biopsy tests. The next liquid
biopsy oncology tests in development are the Idylla(TM) extended RAS tests for
colorectal cancer (i.e. KRAS and NRAS).
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For more information, please contact:
Renate Degrave, Corporate Communications & Investor Relations
rdegrave(at)biocartis.com
+32 15 631 729
About Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics
(MDx) company providing next generation diagnostic solutions aimed at improving
clinical practice for the benefit of patients, clinicians, payers and industry.
Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-
result, real-time PCR (Polymerase Chain Reaction) system that offers accurate,
highly reliable molecular information from virtually any biological sample in
virtually any setting. Biocartis launched the Idylla(TM) platform in September
2014. Biocartis is developing and marketing a rapidly expanding test menu
addressing key unmet clinical needs in oncology and infectious diseases. These
areas represent respectively the fastest growing and largest segments of the MDx
market worldwide. Today, Biocartis has four oncology tests and one test for
infectious disease on the market. More information: www.biocartis.com. Follow us
at (at)Biocartis_.
About the American Association for Cancer Research
Founded in 1907, the American Association for Cancer Research (AACR) is the
world's oldest and largest professional organization dedicated to advancing
cancer research and its mission to prevent and cure cancer. AACR membership
includes more than 35,000 laboratory, translational, and clinical researchers;
population scientists; other health care professionals; and patient advocates
residing in 101 countries. The AACR marshals the full spectrum of expertise of
the cancer community to accelerate progress in the prevention, biology,
diagnosis, and treatment of cancer by annually convening more than 30
conferences and educational workshops, the largest of which is the AACR Annual
Meeting with nearly 19,300 attendees. In addition, the AACR publishes eight
prestigious, peer-reviewed scientific journals and a magazine for cancer
survivors, patients, and their caregivers. The AACR funds meritorious research
directly as well as in cooperation with numerous cancer organizations. As the
Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review,
grants administration, and scientific oversight of team science and individual
investigator grants in cancer research that have the potential for near-term
patient benefit. The AACR actively communicates with legislators and other
policymakers about the value of cancer research and related biomedical science
in saving lives from cancer. For more information about the AACR, visit
aacr.org.
--------------------------------------------------------------------------------
[1] Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of
Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics
System. Mol Cancer Ther (2016) 15(6): 1-8.
[2] Involving the need for taking tumour tissue biopsy.
[3] Idylla(TM) ctBRAF Mutation Assay is for Research Use Only and not for use in
diagnostic procedures. The Idylla(TM) platform and the Idylla(TM) ctBRAF
Mutation Assay are not for sale in the USA and Canada.
[4] Diaz and Bardelli, Liquid Biopsies: Genotyping Circulating Tumor DNA. J clin
Oncol (2014) 32: 579-586.
[5] Schreuer et al. Quantitative assessment of BRAF V600 mutant circulating
cell-free tumor DNA as a tool for therapeutic monitoring in metastatic melanoma
patients treated with BRAF/MEK inhibitors. J Transl Med (2016) 14:95.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
[HUG#2014352]
Unternehmensinformation / Kurzprofil:
Datum: 23.05.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 472764
Anzahl Zeichen: 10524
contact information:
Town:
Mechelen
Kategorie:
Business News
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