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
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
Menu update
Financial update
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
Financial calendar 2017
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More information:
Renate Degrave
Manager Corporate Communications & Investor Relations
e-mail rdegrave@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: @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.
[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.
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