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PRESS RELEASE: Study demonstrating high performance of Idylla™ liquid biopsy RAS tests to be presented at ASCO Annual Meeting

Mechelen, Belgium, 18 May 2017 - Biocartis Group NV (‘Biocartis’ or the ‘Company’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of a study abstract1 demonstrating the high performance of Biocartis’ recently launched Idylla™ ctRAS liquid biopsy assays, which will be presented at the renowned ASCO Annual Meeting of the American Society of Clinical Oncology between June 2-6 in Chicago, US. The ASCO Annual Meeting is attended by more than 30,000 oncology professionals from all over the world.

Understanding the individual gene mutations that drive a cancer is essential for timely cancer treatment decision-making. In many hospitals and laboratory settings, RAS biomarker testing is not available due to the technical complexity of conventional test methods. Consequently, samples often have to be shipped to reference laboratories for analysis, which results in long turnaround times. Additionally, tumor tissue from metastatic patients is not always available or accessible in time.

 

In the study, conducted in collaboration with Prof. Pierre-Laurent Puig (Paris, France), plasma samples from 198 patients with metastatic colorectal cancer (mCRC) were used to compare the Idylla™ ctKRAS Mutation Assay (RUO2) and the Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO) to a deep Next-generation sequencing (NGS) reference method3. The Idylla™ assays used in the study require only 1 ml of plasma each, which was added directly into the Idylla™ cartridge, resulting in less than one minute hands-on time and a turnaround time of less than 130 minutes.

 

The comparison resulted in an overall concordance of 97%. As such, the study concluded that Biocartis’ Idylla™ ctRAS liquid biopsy assays enable rapid and highly reliable detection of mutations in the RAS genes, which occur in around 50%4 of mCRC patients.

 

The Idylla™ ctKRAS Mutation Assay (RUO) and the Idylla™ ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO) were developed under the partnership with Merck KGaA (Darmstadt, Germany), announced in January 2016. Under the same partnership, CE-marked IVD versions of the liquid biopsy RAS biomarker assays are expected to be launched in the second half of 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

Twitter: @Biocartis_

LinkedIn: www.linkedin.com/Biocartis

 

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™ 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 eight 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. 

 


1 Jacobs et al., “Evaluation of a fully automated extended RAS-BRAF test on prospectively collected plasma samples from patients with metastatic colorectal cancer”, to be presented at ASCO, June 2-6, 2017.
2 Research Use Only, not for use in diagnostic procedures.
3 As a comparator test, NGS analysis with a sensitivity of 0.2% was performed on extracted plasma ctDNA according to Pécuchet et al. (2016).
4 Jean-Yves Douillard, M.D., Ph.D., Kelly S. Oliner, Ph.D., Salvatore Siena, M.D., et al. Panitumumab–FOLFOX4 Treatment and RAS Mutations in Colorectal Cancer. N Engl J Med 2013;369:1023-34.

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