Biocartis Group NV: Biocartis launches advanced EGFR Mutation Assay detecting over 50 mutations
(Thomson Reuters ONE) -
PRESS RELEASE
Biocartis launches advanced EGFR Mutation Assay detecting over 50 mutations
Important addition to Biocartis' core oncology menu now covering most known and
used oncology biomarkers
Mechelen, Belgium, 21 June 2016 - Biocartis Group NV ('Biocartis'), an
innovative molecular diagnostics company (Euronext Brussels: BCART),
demonstrates that it continues to deliver on its promises with today's launch of
the Idylla(TM) EGFR[1] Mutation Assay (RUO[2]). This advanced, fully automated
molecular test is designed to detect over 50 EGFR mutations which commonly occur
in lung cancer. Its extreme ease-of-use allows for testing, irrespective of
location or laboratory expertise level. As such, this assay has the potential to
enable more wide-spread testing of lung cancer specimens. The Idylla(TM) EGFR
Mutation Assay is a key addition to Biocartis' menu, now consisting of seven
assays of which five in the field of oncology, and covering most of the known
and used oncology biomarkers on the market today.
Lung cancer and EGFR testing today: complex, lengthy and not accessible for
everyone
Lung cancer is the most common cancer worldwide, accounting for 13% of all
cancer types[3]. A total of 85% of lung cancers are non-small cell lung cancers
(NSCLC)[4]. In these cancers, EGFR mutations occur in 10-15% of Western patients
and in up to 50% of Asian patients[5]. The number of NSCLC cases where patients
benefit from standard, non-targeted treatments, is limited. The introduction of
targeted treatments that are aimed at the epidermal growth factor receptor
(EGFR) pathway in NSCLC has begun to improve outcomes in patients with advanced
NSCLC.
Molecular testing of lung cancer samples today is a very complex and often
lengthy process: it can take up to several weeks[6] before results are
generated. This is mainly related to the difficulty of obtaining high quality
tissue samples. These are often small in size, with a limited amount of
available lung tumour tissue, leading to failure of test results in 20-30% of
the cases[7]. Finally, many laboratories do not have the necessary complex
infrastructure, as different technologies are often needed to optimise EGFR
detection in small samples. Consequently, laboratories often send out their
samples to other testing facilities, resulting in long waiting times.
Fast and easy to use, based on a single tumour slice
With globally accessible molecular testing solutions as a key focus, Biocartis
has developed the Idylla(TM) EGFR Mutation Assay, set up to run on Biocartis'
Idylla(TM) platform and designed to improve current complex EGFR testing
workflows. The assay is performed with a single slice of tumour[8] tissue. In
addition, recent research studieswith the Idylla(TM) EGFR Mutation Assay
conducted by Prof. Troncone and Dr. Malapelle at the Institute Frederico II
(Naples, Italy), demonstrated that very small cytological samples could also be
used, and that the assay could rescue DNA leftovers inadequate for use with
standard testing methods such as next generation sequencing, while generating a
valid result in >97% of cases[9].
Simultaneous detection of over 50 different mutations
By integrating the latest selective amplification and multiplexing technologies,
the Idylla(TM) EGFR Mutation Assay allows simultaneous detection of more than
50 different mutations, with minimal tumour sample or DNA input requirements[10]
and without compromising on sensitivity[11]. The turnaround time of the assay is
approximately 2.5 hours, from sample to result, with less than two minutes
hands-on time. The Idylla(TM) technology has the potential to generate molecular
testing results within one day, which greatly exceeds the current ESMO and
international guidelines of seven days.
Geert Maertens, Chief Scientific Officer of Biocartis, commented: "Our seventh
Idylla(TM) assay, the EGFR Mutation Assay, truly is a unique test from various
perspectives. Being by far the easiest and fastest test for EGFR mutations
available, it detects a broader range of mutations compared to standard tests
and only requires a small amount of sample. We see great potential in Europe as
well as in Asia where EGFR mutations in NSCLC occur in up to 50% of
patients[12]. It is also a great solution both for large reference centres where
this new assay is able to complement current workflows in a versatile, fast and
cost-effective way, as well as for countries or regions where local
accessibility to high precision EGFR testing is limited, or even non-existing.
As such, we are convinced this assay will further boost the growth of our
installed base of Idylla(TM) instruments across the globe."
Prof. Giancarlo Troncone, Department of Public Health, Anatomic Pathology Unit,
University of Napoli Federico II School of Medicine (Napoli, Italy), stated:
"Today, EGFR testing is a cumbersome process and it often takes several weeks
before results are analysed. This may lead to the administration of anti-EGFR
therapy as second-line therapy, which is less efficient than their use in first-
line therapy. The Idylla(TM) EGFR Mutation Assay technology has the potential to
change that: it is a cost-effective solution, ensuring accurate and fast
detection of all relevant mutations."
A CE-marked IVD version of the Idylla(TM) EGFR Mutation Assay is planned for
2017. Biocartis also has a liquid biopsy version under development.
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For more information:
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 five oncology tests and two tests for
infectious disease on the market. More information: www.biocartis.com. Press
Photo Library available here. Follow us at (at)Biocartis_.
Cautions Concerning Forward-Looking Statements
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looking, which reflect the current intentions, beliefs, expectations and
projections of the Company and its directors and management concerning future
events such as the Company's results of operations, financial condition,
liquidity, performance, prospects, growth, strategies and the industry in which
Company operates. By their nature, forward-looking statements involve a number
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in demand, competition and technology, can cause actual events, performance or
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looking statements contained in this press release regarding past trends or
activities are not guarantees of future performance and should not be taken as a
representation that such trends or activities will continue in the future. In
addition, even if actual results or developments are consistent with the
forward-looking statements contained in this press release, those results or
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As a result, the Company expressly disclaims any obligation or undertaking to
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date of this press release.
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[1] Epidermal Growth Factor Receptor.
[2] The Idylla(TM) EGFR Mutation Assay is intended for Research Use Only, not
for diagnostic procedures. Not for sale in the USA and Canada.
[3] Navani et al. Lancet Respir Med (2015).
[4] American Cancer Society. Global cancer Facts & Figures 2nd Edition.
[5] Cooper et al. Molecular biology of lung cancer. J Thorac Dis (2013).
[6] Neal I. Lindeman et al. Molecular Testing Guideline for Selection of Lung
Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors, Guideline from the
College of American Pathologists, International Association for the Study of
Lung Cancer, and Association for Molecular Pathology (2014).
[7] Estimated by Biocartis management.
[8] The analysis is done based on a slice of FFPE (formalin fixed paraffin
embedded) tumour.
[9] De Luca et al. ASCO 2016.
[10] Minimum 1 x 5 µm FFPE tissue section with more than or equal to 10% tumour
cells.
[11] An average sensitivity of smaller than or equal to 1 to smaller than or
equal to 5% based on research data.
[12] Cooper et al. Molecular biology of lung cancer. J Thorac Dis (2013)
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Source: Biocartis Group NV via GlobeNewswire
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