Study on Performance Data of Idylla™ NRAS-BRAF Mutation Assay at 71st AACC Annual Scientific Meeting in Anaheim, CA (US)


Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that a study1 poster on the performance of the Idylla™ NRAS-BRAF Mutation Assay (RUO2) will be presented by Dr. Gregory Tsongalis (Director, Laboratory for Clinical Genomics and Advanced Technology of the Dartmouth-Hitchcock Medical Center) at the 71st AACC (American Association for Clinical Chemistry) Annual Scientific Meeting taking place between 4-8 August in Anaheim, CA (US). 

The study concludes that the Idylla™ system offers rapid and accurate testing of NRAS and BRAF mutations in melanoma directly from FFPE3 tissue, and that its simplicity and ease of use compared to other available molecular techniques make it suitable for small centers that lack specifically trained staff and infrastructure. Furthermore, the study concludes that the Idylla™ system can also complement NGS (Next-Generation Sequencing) by providing much faster turnaround times.

In the study, twenty-two archived FFPE melanoma tissue specimens were tested on the Idylla™ system using the Idylla™ NRAS-BRAF Mutation Assay (RUO). Among these samples, eight had a mutation in BRAF, six had a mutation in NRAS, and eight had no mutations in BRAF or NRAS as determined by previous NGS testing4. The Idylla™ system successfully detected mutations in BRAF and NRAS and results were in full agreement with those previously obtained by NGS. Idylla™ produced results quickly with a turnaround time of approximately two hours.

Dr. Gregory Tsongalis, PhD, Director of the Laboratory for Clinical Genomics and Advanced Technology at Dartmouth-Hitchcock Medical Center, explains: “The Idylla™ system has the potential to play a significant role in rapid screening for actionable mutations prior to NGS analysis, also for small laboratory centers that lack staff with molecular diagnostics training and infrastructure.”

The poster will be presented on 7 August 2019 by Dr. Gregory Tsongalis, PhD, Director, Laboratory for Clinical Genomics and Advanced Technology at Dartmouth-Hitchcock Medical Center at the 71st AACC Annual Scientific Meeting in Anaheim, CA (US).




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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 is developing and marketing a continuously expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: Press Photo Library available here. Follow us on Twitter: @Biocartis_.
Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

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1 M. Rabie Al-Turkmani et al., ‘Evaluation of a Cartridge-Based System for Rapid Detection of BRAF and NRAS Mutations in Melanoma’, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, first published at the 71st AACC Annual scientific meeting & clinical lab expo, 4-8 August 2019, Anaheim (CA), US, available on!/6831/presentation/566.
2 Research Use Only, not for use in diagnostic procedures.
3 Formalin Fixed, Paraffin Embedded.
4 Using the Ion AmpliSeq 50-gene Cancer Hotspot Panel v2 (Thermo Fisher Scientific).



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