Biocartis Group NV: Biocartis launches world's first fully automated liquid biopsy assay and its second tissue assay for colorectal cancer
(Thomson Reuters ONE) -
Biocartis launches world's first fully automated liquid biopsy assay and its
second tissue assay for colorectal cancer
Launch of two new tests on its Idylla(TM) molecular diagnostics platform
strengthens the company's assay menu
Mechelen, Belgium, 22 December 2015 - Biocartis (Euronext Brussels: BCART), an
innovative molecular diagnostics company, today announces the launch of two new
products on its molecular diagnostics platform Idylla(TM). The Idylla(TM) ctBRAF
Mutation Assay uses blood plasma as a sample, which is far less invasive to
obtain compared to tissue biopsies. As plasma samples can repeatedly be obtained
and do not require prior information on the tumour location, liquid biopsy
testing opens up a range of new possibilities in terms of efficient cancer
monitoring and treatment. The second assay launched by Biocartis is the tissue
biopsy Idylla(TM) NRAS-BRAF-EGFR S492R Mutation Assay. This assay now allows
Biocartis to offer a complete RAS-BRAF analysis that can be performed on a same-
day basis, which opens up the route towards faster treatment selection ('same
day results'). Both assays are initially launched as Research Use Only (RUO)
products.
Rudi Pauwels, CEO Biocartis, adds: "We are thrilled about the two new assays,
which strengthen our growing Idylla(TM) menu. Liquid biopsy testing has the
potential to significantly improve the early diagnosis and monitoring of cancer
and Biocartis can now enable both tissue and liquid biopsy testing on the same
instrument, in the same lab. With our new Idylla(TM) NRAS-BRAF-EGFR S492R
Mutation Assay, we are now enabling same-day RAS testing. These developments, in
line with our stated menu strategy at the time of the third quarter results,
underline our success in delivering high precision diagnostics for high
precision medicine in virtually any setting, to patients worldwide."
Launch of first liquid biopsy assay
Research over the last few years has shown that fragments of tumour DNA are shed
into the blood from primary tumours or metastatic sites[1]. 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. This observation has led to the development of
technologies for liquid biopsy testing. According to J.P. Morgan, the global
market of liquid biopsy tests is estimated to reach $20 billion by 2020.
The Idylla(TM) ctBRAF Mutation Assay is the world's first and only fully
automated liquid biopsy assay that can potentially act as a substitute for
tissue biopsy testing in melanoma, colorectal and lung cancers, as well as
conditions such as hairy cell leukaemia and histiocytosis[2]. The assay has a
turnaround time of approximately 90 minutes with less than one minute of hands-
on time.
With an earlier prototype of the assay, Schreuer et al.[3] have shown that
analysis of BRAF mutant circulating tumour DNA (ctDNA) from plasma using
Idylla(TM) allows for a rapid determination of the BRAF status in samples from
patients with advanced melanoma, and that the amount of mutant BRAF ctDNA may be
an indication of tumour growth. The ability to rapidly analyse BRAF mutations in
plasma of patients holds promise as a therapeutic monitoring tool for patients
with advanced BRAF V600 mutant melanoma.
Prof. Dr. Bart Neyns, Head of Medical Oncology at the University Hospital
Brussels, said: "Liquid biopsies represent a number of benefits. Theoretically,
liquid biopsies allow, based on a simple blood sample, for patients rapidly
deteriorating from cancer, to receive a diagnosis and optimal treatment on the
very same day."
In October of this year, Biocartis announced that it has received a grant from
the Flemish Agency for Innovation by Science and Technology (IWT) to support the
research and development of liquid biopsy tests.
Same-day RAS testing
The tissue biopsy Idylla(TM) NRAS-BRAF-EGFR S492R Mutation Assay is complemented
by the current already CE-marked Idylla(TM) KRAS Mutation Test (tissue biopsy
test). Together, these provide for a complete metastatic colorectal cancer
(mCRC) mutation analysis, from two slices of so-called formalin-fixed paraffin
embedded (FFPE) tumour tissue.
CRC is the second most common cancer worldwide, with an estimated incidence of
more than 1.36 million new cases annually[4]. According to the International
Agency for Research on Cancer, an estimated 694,000 deaths from CRC occur
worldwide every year, accounting for 8.5% of all cancer deaths and making it the
fourth most common cause of death from cancer.
At the 40th European Cancer Congress in September 2015 (Vienna, Austria),
Biocartis presented a study called 'A solution for same-day extended RAS
testing'. For the first time in the molecular pathology field, this assay allows
to perform a complete RAS analysis on a same-day basis, opening up the route
towards faster treatment selection.
The Idylla(TM) KRAS Mutation Test and new Idylla(TM) NRAS-BRAF-EGFR S492R
Mutation Assay together are able to detect 39 KRAS and NRAS mutations ("extended
RAS") at high sensitivity, in line with the novel clinical guidelines as
recently issued by ASCO/AMP/NCI[5] (including 5% limit of detection). The new
assay detects 18 NRAS mutations as well as five BRAF mutations, for which
testing is now mandatory in patients with mCRC(1). The assay also uniquely
detects the so-called EGFR S492R mutation, which is associated with resistance
to certain anti-EGFR therapies.
Geert Maertens, Chief Scientific Officer Biocartis, commented: "With our new
Idylla(TM) NRAS-BRAF-EGFR S492R Mutation Assay, we can now offer a complete RAS-
BRAF analysis for all clinically actionable biomarkers, in line with the newest
clinical guidelines in mCRC, to be performed on a same-day basis. In addition,
the assay includes the recently discovered EGFR S492R mutation[6], illustrating
Biocartis' continuous drive for innovation."
Both products are specifically developed on Biocartis' fully integrated
Idylla(TM) molecular diagnostics platform, which was commercially launched in
September 2014. Since then, four oncology and one infectious disease test have
been launched for use on the Idylla(TM) platform.
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).
----- END ----
Biocartis
Renate Degrave (Corporate Communications & Investor Relations)
+32 15 632 600 | press(at)biocartis.com
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Chris Welsh, Hendrik Thys
+44 (0) 203 709 5701 (London, UK) | biocartis(at)consilium-comms.com
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. Idylla(TM) addresses the growing demand for personalized
medicine by allowing fast and effective treatment selection and treatment
progress monitoring.
Biocartis launched the Idylla(TM) platform commercially in September 2014
together with its first test to identify BRAF mutations in metastatic melanoma.
In June 2015, the Idylla(TM) KRAS Mutation Test for colorectal cancer was
launched, followed by the first infectious disease test in November 2015, the
Idylla(TM) Respiratory (IFV-RSV) Panel, developed in collaboration with Janssen
Diagnostics. Biocartis is developing and marketing a rapidly expanding test menu
addressing key unmet clinical needs in oncology and infectious diseases. These
areas respectively represent the fastest growing and largest segments of the MDx
market worldwide. More information: www.biocartis.com
--------------------------------------------------------------------------------
[1] Diaz and Bardelli, Liquid Biopsies: Genotyping Circulating Tumor DNA. J clin
Oncol (2014) 32: 579-586.
[2] Histiocytosis is a general name for a group of disorders or "syndromes" that
involve an abnormal increase in the number of immune cells that are
called histiocytes. Source:
https://www.nlm.nih.gov/medlineplus/ency/article/000068.htm, December 2015.
[3] Schreuer et al. Quantitative assessment of BRAF V600 mutant cell-free tumor
DNA from plasma as a diagnostic and therapeutic biomarker in pts with BRAF V600
mutant melanoma. J Clin Oncol 33, 2015 (suppl; abstr 9015).
[4] Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M,
Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality
Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency
for Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Last
accessed December 2015.
[5] ASCO = American Society of Clinical Oncology, AMP = Association for
Molecular Pathology and NCI = National Cancer Institute.
[6] The mutation was discovered in 2012 by Prof. Montagut and Dr. Albanell's
team at the Medical Oncology Service, Hospital del Mar (Barcelona, Spain), where
it was shown that the mutation blocks binding of the anti-EGFR antibody
cetuximab, making that treatment ineffective.
This announcement is distributed by GlobeNewswire on behalf of
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(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
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Datum: 22.12.2015 - 07:00 Uhr
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News-ID 441168
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