Partnership aimed at the development of molecular diagnostic assays on Biocartis’ fully automated Idylla™ platform
London (UK) / Mechelen (Belgium), 7 June 2017 – MRC Technology (‘MRCT’), a medical research charity, and Biocartis Group NV (‘Biocartis’ or the ‘Company’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced a partnership to develop selected molecular diagnostic tests for use on Biocartis’ fully automated Idylla™ platform. MRCT aims to move promising medical research forward into patient treatments and diagnostics and has been involved in helping deliver a number of therapies including Keytruda® (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers.
Under the terms of the agreement, Biocartis and MRCT will jointly develop selected molecular diagnostic tests for use on the fully automated Idylla™platform. For each selected test, MRCT will act as a development contractor, whereas Biocartis will be responsible for the commercialization of the tests under its own label. Financial details of the partnership are not disclosed.
The first test to be developed under the partnership is a liquid biopsy test aimed at monitoring of metastatic breast cancer patients for resistance to hormone therapy. This is an important first step in the breast cancer menu that Biocartis is developing, and has a clear strategic fit within the Company’s focus on liquid biopsy testing.
One in eight women is diagnosed with breast cancer in her lifetime, according to the World Health Organization. This makes it the most common cancer among women worldwide but early diagnosis can improve the survival rate . Consequently, breast cancer is currently the largest cancer diagnostics market in the world , expected to account for USD 13.1bn by 2020. As such, it represents an important segment for Biocartis to enter, next to its current focus on melanoma, lung and colorectal cancer.
Erwin Sablon, Head of R&D and Alliance Management at Biocartis, commented: “Building partnerships with third parties to accelerate the expansion of our menu of molecular diagnostic tests is a key element in our strategy. We are very pleased to be partnering with MRCT, an organization that has clearly shown the ability to convert promising medical research into solutions for patients. MRCThas an experienced team in place and we are confident that together we can successfully develop a range of high quality tests for the Idylla™ platform, beginning with this first test for breast cancer.”
Michael A. Dalrymple, PhD, MBA, Director, Diagnostics & Science Foresight MRCT, reacted: “We are excited to partner with Biocartis on test development for the Idylla™ platform, which we believe can impact the way molecular diagnostics for oncology is done today. This resonates well with our focus of translating medical innovation into viable and accessible treatments and diagnostics that patients can benefit from. Breast cancer has an enormous impact on many lives every day and we see this assay as an important project to start our partnership with.”
Within its melanoma and colorectal cancer menu, Biocartis already launched three liquid biopsy assays (available for research use only), detecting a large set of actionable mutations directly from 1 ml of blood plasma each. The fourth liquid biopsy assay, the Idylla™ ctEGFR Mutation Assay, adding to Biocartis’ lung cancer test menu, is expected to be launched in H2 2017.
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MRC Technology is an independent life science medical research charitycommitted to improving positive patient outcomes everywhere. As a champion for human health, MRC Technology partners with academic, biotechnology, pharmaceutical and charity organisations to move promising medical research forward into viable and accessible patient treatments. As a self-funded charity, income is reinvested to support translating research from the bench to patient. MRC Technology offers commercialization and IP management skills and diagnostic and drug discovery expertise, specializing in small molecules and therapeutic antibodies. www.mrctechnology.org. MRC Technology’s work has helped to develop four drugs (Keytruda®, Actemra®,Tysabri® and Entyvio®) and a test for antimicrobial resistance.
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™ 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™ 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 offers nine oncology tests and two infectious disease tests. 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.
 Source: World Cancer Research Fund International, http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/breast-cancer-statistics, last consulted on 17 May 2017.
 Source: http://www.nationalbreastcancer.org/breast-cancer-facts, last consulted on 15 May 2017.
 Source: GrandView Research, “Cancer Diagnostics Market Analysis By Type (Laboratory Tests, Genetic Tests, Imaging,Endoscopy), By Application (Breast, Lung, Liver, Cervical, Colorectal, Skin),By Region, And Segment Forecasts, 2014 – 2025”, http://www.grandviewresearch.com/industry-analysis/cancer-diagnostics-market, lastconsulted on 15 May 2017.
 Source: Marketsand Markets, “Cancer Diagnostics Market by Technology (ELISA, ELFA, PCR, NGS, Immunohistochemistry, Microarray, Imaging (MRI, CT, PET, Ultrasound, Mammography), Biopsy), by Application (Breast Cancer, Lung Cancer, Colorectal Cancer, Melanoma) -Forecast to 2020”, 2015.
 TheIdylla™ ctBRAF Mutation Assay, the Idylla™ ctKRAS Mutation Assay and the Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay are Research Use Only (RUO) and not for use in diagnostic procedures.