Biocartis Launches European Commercialization of SkylineDx’s Innovative Merlin™ (CE-IVD) Test for Melanoma Patients


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PRESS RELEASE: September 1, 2022, 07:01 CEST

Biocartis Launch the marketing in Europe of SkylineDx innovation Merlin Test (CE-IVD) for melanoma The patients
Merlin helps identify melanoma patients who can safely quit sentinel lymph node biopsy

  • The melanoma is deadliest form of skin cancer1
  • Biocartis initiatesyou marketing in Europe of SkylineDx innovation Merlin Test, before launching anot Idylla™ version of test

Mechelen, Belgium, September 1st 2022 Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the start of commercialization in Europe of SkylineDx’s innovative Merlin test as a CE-IVD marked manual kit. The test, developed by SkylineDx in collaboration with the Mayo Clinic (USA), aims to predict a patient’s risk of lymph node metastasis with melanoma and can help to safely forego invasive surgery, which is now often performed to determine the metastatic spread of cancer for staging purposes. In about 80% of surgeries, the biopsy comes back negative for metastases, where it does not further impact the patient’s journey. Merlin Assay Provides More Personalized Insight, Identifying Low-Risk Tumor Patients Who May Avoid Surgery2. The Merlin test will be marketed in Europe by Biocartis in the form of a CE-IVD marked manual kit, before the launch of an Idylla™ version of the test which is under development.

Biocartis and SkylineDx, a private biotechnology company based in the Netherlands (Rotterdam) and the United States (San Diego, CA), announced their partnership agreement on April 22, 2021. Under the terms of the partnership agreement, SkylineDx is leading development of the Merlin test on Idylla™, while Biocartis is leading commercialization in Europe through its growing Idylla™ network. As part of the marketing in Europe, Biocartis will now also market the CE-IVD marked manual kit, before the Idylla™ version of the Merlin test. In the United States, the test is already available as a lab-developed test from SkylineDx’s CAP/CLIA lab. SkylineDx received Medicare reimbursement for the test in May 2022.

Herman Verrelst, CEO of Biocartis, said: We are very excited to begin marketing SkylineDx’s CE-IVD marking in Europe. manual Merlin kit Test. This The manual kit is based on a well-established qPCR method that can easily be performed in molecular diagnostic laboratories. although Ithis is the first time that we market a partner test before a Idylla™ version of the test, this version of the Merlin test can offer our European customers of major molecular diagnostic laboratories already clear added value to help improve outcomes for melanoma patients. Once finished, the The Idylla™ version of the Merlin test should allow even wider access to melanoma patients across Europe, with a reduced time to results.

Dharminder VSHahal, CEO of SkylineDx, replied: Launch the Merlin Test as a The CE-IVD marked manual kit in Europe represents a major milestone in bringing our diagnostic solutions to patients around the world. We look forward to entering this new phase of our partnership with Biocartis. »

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More information:
Renate Degrave
Corporate Communication & Investor Relations Manager Biocartis
E-mail [email protected]
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™ platform is a fully automated real-time PCR (Polymerase Chain Reaction) system that delivers accurate and highly reliable molecular information from virtually any biological sample in virtually any environment. Biocartis develops and markets an ever-expanding menu of tests addressing key unmet clinical needs, with a focus on oncology, which represents the fastest growing segment of the MDx market globally. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as COVID-19, influenza, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

About SkylineDx
SkylineDx is a biotechnology company focused on the research and development of molecular diagnostics in oncology and inflammatory diseases. The company is based in Rotterdam (the Netherlands) and complemented by a commercial team, a field medical and scientific affairs team and a CAP/CLIA certified laboratory in San Diego (CA, USA). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with great clinical utility, helping healthcare professionals to accurately determine the type or condition of disease or to predict a patient’s response to treatment. Based on the test results, healthcare professionals can tailor the treatment approach to each patient. To learn more about SkylineDx, please visit www.skylinedx.com.

About Merlin Test
Merlin Assay uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes3. The model is able to calculate risk on an individual basis through a combined analysis of eight genes of the patient’s primary tumor, tumor thickness and patient age; and has been analytically and clinically validated. Further clinical research and validation studies on the predictive use of the CP-GEP model are the focus of the Merlin study initiative, developed under the Falcon R&D program. More information (including references) can be obtained at www.falconprogram.com. Its American counterpart Merlin Test is commercially available and Medicare reimbursed in the United States as a laboratory-developed test insured by SkylineDx’s CAP/CLIA laboratory in San Diego (CA).

Biocartis and Idylla™ are registered trademarks in Europe, USA and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks belonging to Biocartis. Please refer to the product labeling for the applicable intended uses for each individual Biocartis product.

This press release is not intended for distribution, directly or indirectly, in any jurisdiction where it would be illegal. Anyone reading this press release should inform themselves about and observe these restrictions. Biocartis assumes no responsibility for any violation of these restrictions by anyone. This press release does not constitute an offer or invitation to sell or buy 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 United States Securities Act of 1933, as amended.

Forward-looking statements
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, if applicable, of the directors or management of the Company regarding future events such as 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 statements. prospective. 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, may cause actual events, performance or results to differ materially 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. Furthermore, even if actual results or developments are consistent with the forward-looking statements contained in this press release, such results or developments may not be indicative of results or developments in future periods. No representation or warranty is made as to the accuracy or correctness of these forward-looking statements. Accordingly, the Company expressly disclaims any obligation or undertaking to issue updates or revisions to any forward-looking statements contained in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which such forward-looking statements are based, except as expressly required by law or regulation. Neither the Company, nor its advisers or representatives, nor any of its subsidiaries or the officers or employees of such persons warrant that the assumptions underlying these forward-looking statements are free from error and accept no responsibility for the future accuracy of forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


1 Source: https://www.nccn.org/patients/guidelines/content/PDF/melanoma-patient.pdf, last accessed August 24, 2022
2 Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206.
3 Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). https://doi.org/10.1200/PO.19.00206