Biocartis Group NV: Biocartis Q1 2017 Business Update
(Thomson Reuters ONE) -
PRESS RELEASE: REGULATED INFORMATION
Thursday, 27 April 2017, 07:00 CEST
BIOCARTIS Q1 2017 BUSINESS UPDATE
Mechelen, Belgium, 27 April 2017 - Biocartis Group NV (the 'Company' or
'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels:
BCART), today provides a business update for the first quarter of 2017, selected
post period events and an outlook for the remainder of the year.
Key messages
* Commercial: Commercial cartridge volume Q1 2017 over 4.5 times Q1 2016
volume. 2017 guidance reiterated: installed base to grow with 250-275
Idylla(TM) instruments and 2017 annual commercial cartridge volume to be at
least three times 2016 volume.
* Menu: Continued progress made in expansion oncology menu; CE-marking EGFR
solid biopsy test (lung cancer menu) expected in Q2 2017.
Commenting on the business update, Hilde Windels, interim Chief Executive
Officer of Biocartis, said: "During the first quarter of 2017, we advanced the
worldwide adoption of our Idylla(TM) platform. The strong ramp-up of commercial
cartridge volumes that we showed in 2016 was continued in Q1 2017, both in
Europe and in our distribution markets. Preparations are ongoing to start US
commercialization in the second half of this year and I am pleased about our
recent announcement of the appointment of Vishal Sikri as our General Manager
for the US."
Commercial and regulatory update
* Cartridge consumption - Driven by the ongoing installed base growth and menu
expansion, Biocartis' commercial Idylla(TM) cartridge consumption in Q1
2017 increased to over 4.5 times the Q1 2016 volume.
* Installed base - Idylla(TM) installed base expansion was further continued
in Q1 2017, on track to meet guidance of increasing the installed base to
over 640 instruments by year end.
* CDx business - In January 2017, Biocartis launched its companion diagnostics
(CDx) business with the signing of the first CDx partnership with an
undisclosed pharmaceutical company (ranked amongst the global top 10
pharmaceutical companies in terms of sales) for the joint development of an
Idylla(TM) CDx test for an undisclosed phase II oncology compound.
* Commercial footprint - During Q1 2017, Biocartis obtained new market
authorizations in Asia and the Middle East. Furthermore, Biocartis initiated
the training of the sales force of Fisher Healthcare (a division of Thermo
Fisher Scientific) on the Idylla(TM) platform as part of Biocartis'
execution plan to start US commercialization in H2 2017.
* Regulatory - On 14 March 2017, the US FDA published[1] a preliminary list of
devices it plans to exempt from 510(k) premarket notification requirements,
subject to certain limitations such as point of care testing. This
preliminary list includes real-time PCR devices such as the Idylla(TM)
Instrument and Console. Following a public comment period, a final list is
expected to be published and implemented by early July 2017 and could lower
the regulatory requirements for the Idylla(TM) platform[2] in the US.
Menu update
* Lung cancer menu - During Q1 2017, Biocartis completed the clinical
validation testing of the Idylla(TM) EGFR Mutation Assay (RUO[3]) and is on
track to CE-mark this assay in Q2 2017. Lung cancer is the most common
cancer worldwide, accounting for 13% of all cancer types[4]. Having a CE-
marked test for this type of cancer will be an important driver for the
further market adoption of the Idylla(TM) platform. Biocartis aims to launch
later in 2017 the ctEGFR Mutation Assay, a liquid biopsy RUO version of the
Idylla(TM) EGFR Mutation Assay.
* Colorectal cancer menu - On 2 March 2017, Biocartis further expanded its
colorectal cancer offering with the launch of the Idylla(TM) ctNRAS-BRAF-
EGFR S492R Mutation Assay (RUO). This assay launch also marked an important
milestone in the partnership with the leading science and technology company
Merck KGaA[5]. Biocartis' offering for colorectal cancer now consists of two
CE-marked solid biopsy tests (together detecting 44 mutations directly from
a slice of FFPE[6] tumor tissue each) and two liquid biopsy assays[7]
(available for research use only, together detecting 46 mutations directly
from 1 ml of blood plasma each). Furthermore, during Q1 2017 two additional
papers were published on the Idylla(TM) KRAS Mutation Test, reiterating that
this test enables fast and reliable analysis of KRAS mutations, without the
need for experienced laboratory infrastructure or expertise. One study
confirmed that KRAS testing by Idylla(TM) as such can be carried out in the
same center where the patient is diagnosed, which in return allows for a
rapid outcome, needed to adequately guide personalized treatment[8]. The
other study demonstrated successful testing of cytological samples[9] with
Idylla(TM) which is normally outsourced to a small number of specialized
referral molecular pathology laboratories.
* Melanoma menu - On 9 March 2017, Biocartis announced the publication in the
renowned clinical oncology journal 'The Lancet Oncology' of an important
study[10] by Prof. Dr. Bart Neyns from the University Hospital in Brussels
(Belgium). In this study, advanced metastatic melanoma patients that had
become resistant to their BRAF-targeted treatment were successfully given a
retreatment with that same therapy following a three months pause after
resistance confirmation. This is an important finding that could lead to
more routine use of retreatment, especially for patients where no effective
standard treatment is available. Biocartis' liquid biopsy test, the
Idylla(TM) ctBRAF Mutation Assay (RUO), was used in this study for the
monitoring of the mutational status.
Financial update
* MSI grant - In March 2017, Biocartis received a grant from VLAIO, the
Flanders organization for Innovation & Entrepreneurship, of approximately
EUR 750k. The grant supports Biocartis' ongoing microsatellite instability
(MSI) and mutational load research program in collaboration with Prof.
Diether Lambrechts (VIB - KU Leuven Center for Cancer Biology, Belgium), and
aims to support the development of a fully automated MSI test on the
Company's Idylla(TM) platform aimed at colorectal cancer and immunotherapies
for oncology.
* Cash position - Biocartis' cash position end of Q1 2017 amounted to
approximately EUR 70m (unaudited figure). The Company has EUR 25m of
multiple purpose credit lines at its disposal on which no drawdowns were
made as per end of March 2017. Biocartis targets a cash position by the end
of 2017 of around EUR 40m.
Post-period events
On 4 April 2017, Biocartis announced the establishment of its US subsidiary,
Biocartis US Inc., and the appointment of Vishal Sikri as its US General
Manager. Vishal is a highly experienced executive with a proven global
commercial and operational track-record in molecular diagnostics. Before joining
Biocartis, he was Managing Director and VP Commercial Operations responsible for
all global commercial operations of Sysmex Inostics, the molecular diagnostics'
division of Sysmex Corporation (TYO: 6869).
Menu outlook 2017
* CE-marking Idylla(TM) EGFR Mutation Test (Q2 2017).
* CE-marking Idylla(TM) NRAS Mutation Test (Q2 2017): this test will give more
flexibility to customers and will allow for price differentiation with the
Idylla(TM) NRAS-BRAF Mutation Test in geographies where BRAF testing for
mCRC patients is not reimbursed.
* CE-marking Idylla(TM) ctKRAS Mutation Test and Idylla(TM) ctNRAS-BRAF
Mutation Test as part of the partnership with Merck (H2 2017).
* Launch of a liquid biopsy version of the Idylla(TM) EGFR Mutation Assay
(RUO, H2 2017). Note: this product will be initially launched on the basis
of a manual DNA extraction protocol anticipating a fully automated ctEGFR
Mutation Assay (RUO) that is also under development.
* 510(k) approval from the US FDA is expected for the Idylla(TM) Instrument,
the Idylla(TM) Console and the Idylla(TM) Respiratory (IFV-RSV) Panel.
Financial calendar 2017
* Annual General Meeting Biocartis Group NV - 12 May 2017
* H1 2017 results - 7 September 2017
* Q3 2017 business update - 16 November 2017
--- END ---
More information:
Renate Degrave
Manager Corporate Communications & Investor Relations
e-mail rdegrave(at)biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
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 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 eight oncology tests and two infectious
disease tests in its product menu. More information: www.biocartis.com. Press
Photo Library available here. Follow us on Twitter: (at)Biocartis_.
Certain statements, beliefs and opinions in this press release are forward-
looking, which reflect the Company or, as appropriate, the Company directors'
current expectations and projections concerning future events such as the
Company's results of operations, financial condition, liquidity, performance,
prospects, growth, strategies and the industry in which the Company operates. By
their nature, forward-looking statements involve a number of risks,
uncertainties, assumptions and other factors that could cause actual results or
events to differ materially from those expressed or implied by the forward-
looking statements. These risks, uncertainties, assumptions and factors could
adversely affect the outcome and financial effects of the plans and events
described herein. A multitude of factors including, but not limited to, changes
in demand, competition and technology, can cause actual events, performance or
results to differ significantly from any anticipated development. Forward-
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
developments may not be indicative of results or developments in future periods.
As a result, the Company expressly disclaims any obligation or undertaking to
release any update or revisions to any forward-looking statements in this press
release as a result of any change in expectations or any change in events,
conditions, assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or representatives
nor any of its subsidiary undertakings or any such person's officers or
employees guarantees that the assumptions underlying such forward-looking
statements are free from errors nor does either accept any responsibility for
the future accuracy of the forward-looking statements contained in this press
release or the actual occurrence of the forecasted developments. You should not
place undue reliance on forward-looking statements, which speak only as of the
date of this press release.
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[1] Available on https://www.federalregister.gov/documents/2017/03/14/2017-
04938/medical-devices-exemptions-from-premarket-notification-class-ii-devices-
request-for-comments.
[2] Note: this exemption does not hold for assays that are run on the Idylla(TM)
platform.
[3] Research Use Only, not for use in diagnostic procedures.
[4] Navani et al. Lancet Respir Med (2015).
[5] Darmstadt, Germany.
[6] Formalin-fixed paraffin embedded.
[7] The Idylla(TM) KRAS Mutation Test and the Idylla(TM) NRAS-BRAF Mutation Test
are CE-marked IVD tests which can be used in diagnostic procedures. The
Idylla(TM) ctKRAS Mutation Assay and the Idylla(TM) ctNRAS-BRAF-EGFR S492R
Mutation Assay are Research Use Only (RUO) and not for use in diagnostic
procedures.
[8] Weyn et al., 'Clinical performance evaluation of a sensitive, rapid low-
throughput test for KRAS mutation analysis using formalin-fixed, paraffin-
embedded tissue samples', BMC Cancer, published online 16 February 2017.
[9] De Luca et al., 'KRAS detection on archival cytological smears by the novel
fully automated polymerase chain reaction based Idylla(TM) mutation test',
CytoJournal, published on 24 February 2017. Cytology or cytopathology means
diagnosing diseases by looking at single cells and small clusters of cells. It
is an important part of diagnosing some types of cancer. Source: www.cancer.org,
last consulted on 12 April 2017.
[10] Schreuer et al., 'Combination of dabrafenib plus trametinib for BRAF and
MEK inhibitor pretreated patients with advanced BRAFV600-mutant melanoma: an
open-label, single arm, dual-centre, phase 2 clinical trial', The Lancet
Oncology 2017, published online 3 March 2017.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 27.04.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 538637
Anzahl Zeichen: 15930
contact information:
Town:
Mechelen
Kategorie:
Business News
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