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Press news Biocartis Group NV: Biocartis Announces Presentation of First Prospective Validation Study Data of Merlin Test by Partner SkylineDx at EADO 2022 Conference

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PRESS RELEASE: 21 April 2022, 07:01 CEST

Biocartis Announces Presentation of First Prospective Validation Study Data of Merlin Test by Partner SkylineDx at EADO 2022 Conference

Mechelen, Belgium, 21 April 2022 Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced that its partner SkylineDx will present new data showing that its Merlin Test was able to prospectively reduce more than 37% of surgeries in a non-interventional study for newly diagnosed melanoma patients1. The abstract publication receives a designated oral presentation during the 18th Congress of the European Association of Dermato-oncology (EADO) in Sevilla, Spain (21-23 April 2022).

The Merlin Test identifies melanoma patients that have a low risk for nodal metastasis and therefore can safely forgo a sentinel lymph node biopsy (SLNB) surgery. This is an invasive surgical procedure used to determine metastatic spread of the cancer for staging purposes. In approximately 80% of the surgeries, the biopsy comes back negative for metastasis and does not further impact the patient pathway. The Merlin Test provides a more personalized insight on the metastatic propensity of the tumor, and how patients with a low-risk tumor could avoid the surgery2.

Four melanoma medical centers from the Netherlands are leading this prospective multicenter study which is currently still ongoing. The study was initiated during the first wave of the COVID-19 pandemic to allow for surgical triage on SLNB and to evaluate the implementation of the Merlin Test in clinical practice. Results of this prospective trial confirm the performance of previously published European and US retrospective validation studies in real world practice.

On 22 April 2021, Biocartis and SkylineDx announced a partnership aimed at developing SkylineDx’ novel proprietary test, the Merlin Test, on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™. In the US, the Merlin Test is already available as an internal Laboratory Developed Test in SkylineDx’ CAP/CLIA laboratory in San Diego (California, US). Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Test on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network. Ahead of the launch of the Merlin Test on Idylla™, Biocartis will already commercialize the test kit version of the Merlin Test for in vitro diagnostic use in Europe.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: Presenting this new prospective data at the EADO conference is a great way to initiate our joint commercial activities with SkylineDx, addressing mainly centralized expert laboratories in Europe.”

EADO 2022 will be the first European conference that we attend together with our collaboration partner Biocartis”, comments Dharminder Chahal, CEO SkylineDx. “It is exciting that in our first collective outreach we are able to show new prospective data that further strengthens the scientific solidity and clinical relevance of our Merlin Test”.

The commercial launch of the test kit version of the Merlin Test for in vitro diagnostic use in Europe is planned in the second half of 2022.

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More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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™ 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, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for COVID-19, flu, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

About the Merlin Test
The Merlin Test uses the CP-GEP model, a powerful algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been independently validated in several cohorts. Further clinical research and validation studies on the predictive use of the CP-GEP model is the main focus of the Merlin Study Initiative, developed under the wings of the Falcon R&D Program. More information (including references) on www.falconprogram.com.

About SkylineDx
SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego (California). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. More information about SkylineDx on www.skylinedx.com.

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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product.
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. 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.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' 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. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates 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, except if specifically required to do so by law or regulation. 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 Stassen R.C. et al, ‘Use of CP-GEP to identify primary cutaneous melanoma patients with a low risk for SN metastasis in a prospective multicenter Dutch study during COVID-19’, first presented at EADO 2022, 21-23 April 2022 (Seville, Spain). Find the link here
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).


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