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Biocartis Group NV (BCART.BR)

Brussels - Brussels Delayed Price. Currency in EUR
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4.4600+0.2100 (+4.94%)
At close: 5:35PM CEST
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Previous Close4.2500
Open4.3100
Bid0.0000 x 0
Ask0.0000 x 0
Day's Range4.2600 - 4.4800
52 Week Range3.1200 - 5.1900
Volume148,207
Avg. Volume100,351
Market Cap256.654M
Beta (5Y Monthly)1.64
PE Ratio (TTM)N/A
EPS (TTM)-1.1120
Earnings DateFeb. 25, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est17.02
  • GlobeNewswire

    Press news Biocartis Group NV: Biocartis Announces New Collaboration with AstraZeneca to Expand Availability of Idylla™ EGFR Biomarker Testing Among Patients with Lung Cancer

    PRESS RELEASE: 4 May 2021, 07:00 CEST Biocartis Announces New Collaboration with AstraZeneca to Expand Availability of Idylla™ EGFR Biomarker Testing Among Patients with Lung Cancer Approximately half of the patients with non-small cell lung cancer have tumor mutations that could inform a more targeted treatment approach, but many are not tested Mechelen, Belgium, 4 May 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART) today announces to have signed a new agreement with AstraZeneca, a global science-led biopharmaceutical company (LSE/STO/Nasdaq: AZN), aimed at providing access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in Biocartis’ European and global distributor markets1 to support the identification of patients with EGFR mutations. The new project expands the existing master collaboration agreement2 between Biocartis and AstraZeneca, which was established to promote and bolster access to faster molecular diagnostic biomarker results. The project further builds on the conclusion of the large prospective lung cancer FACILITATE study3, co-sponsored by AstraZeneca and presented in September last year at the renowned ESMO Virtual Congress4. This study concluded that Idylla™ EGFR testing may add value in a clinical setting to generate actionable EGFR mutation results for non-small cell lung cancer (NSCLC) patients faster than routinely used methods5. EGFR mutations are important biomarkers in NSCLC, occurring in 10-15% of all NSCLC patients in the US and the EU, and in 30-40% of all NSCLC patients in Asia6. The fully automated Idylla™ EGFR Mutation Test (CE-IVD) covers 51 mutations in a single cartridge using only 1 FFPE7 tissue section from metastatic NSCLC and showing a high concordance of >95% compared with reference methods8. Commenting on the new agreement, Herman Verrelst, Chief Executive Officer of Biocartis, said: “AstraZeneca has become a trusted business partner to Biocartis and I’m very excited to see our partnership with them mature and grow. With this agreement, AstraZeneca will facilitate the onboarding of new Idylla™ users while improving access to the Idylla™ EGFR Mutation Test (CE-IVD). As such, we offer the possibility to improve biomarker identification in patients with non-small cell lung cancer and, in turn, inform tumor management boards to allow precise patient management decisions. This is important, since approximately half of the patients with non-small cell lung cancer have tumor mutations that could inform a more targeted treatment approach9, but many are not tested. Lowering barriers to testing by offering a fully automated diagnostic workflow can make a true difference in the area of lung cancer biomarker testing, which is one of our key strategic pillars in oncology.” --- END --- More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-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 SARS-CoV-2 and sepsis. More information: www.biocartis.com. 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. 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 statementsCertain 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 Excluding US, China and Japan2 Announced on 22 January 20203 Hummel M. et al, “FACILITATE: a real-world multicentre prospective study investigating the utility of a rapid, fully automated RT-PCR assay vs reference methods (RM) for detecting epidermal growth factor receptor mutations (EGFRm) in NSCLC”, ESMO Virtual Congress 2020 (19-21 September 2020), first published online on 14 September 20204 ESMO = European Society for Medical Oncology. The Virtual ESMO Congress took place in September 20205 Poster was presented at ESMO 2020, poster reference 1205P6 Source: https://www.astrazeneca.com/our-focus-areas/oncology/at-the-forefront-of-lung-cancer-treatment.html, last consulted on 27 April 20217 FFPE = formalin fixed, paraffin embedded8 De Luca et al. Journal of Clinical Pathology 2018;71:745-7509 Tuma, Rabiya S. PHD More Than Half of NSCLC Patients Have Actionable Mutations, Lung Cancer Consortium Reports, Oncology Times: October 25, 2011 - Volume 33 - Issue 20 - p 31-32 doi: 10.1097/01.COT.0000407712.33021.9d

  • Press release Biocartis Group NV: BIOCARTIS Q1 2021 BUSINESS UPDATE
    GlobeNewswire

    Press release Biocartis Group NV: BIOCARTIS Q1 2021 BUSINESS UPDATE

    PRESS RELEASE: REGULATED INFORMATION22 April 2021, 07:01 CEST BIOCARTIS Q1 2021 BUSINESS UPDATE70% Cartridge Volume Growth in Q1 2021; New Partnership with SkylineDx on Melanoma Testing Mechelen, Belgium, 22 April 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today provides a business update for the first quarter of 2021 and the outlook for the full year 2021. Commenting on the Q1 2021 Business Update, Herman Verrelst, Chief Executive Officer of Biocartis, said: “Building on investments made last year, we started the year off strong with 70% year-over-year growth of our commercial cartridge volume in Q1 2021. Similar to 2020, growing volumes in oncology were supplemented by continued demand for our Idylla™ SARS-CoV-2 Test1. Oncology volumes were ahead of expectations in European and distributor markets2 while the US cartridge volume growth was still strongly driven by our Idylla™ SARS-CoV-2 Test. We made good progress on menu expansion, both in oncology as well as in infectious diseases, and we remain poised for strong growth in 2021. End of March, we launched the highly innovative Idylla™ GeneFusion Assay (RUO3), which makes fully automated gene fusion testing possible as from now on, even for smaller labs. We also continued to work on our regulatory program: just a few days ago, we achieved a major milestone with our very first US FDA oncology assay submission to the US FDA, with the 510(k) submission of our Idylla™ MSI Test. Once obtained, both large and small US labs will be able to benefit from our fast and easy to use Idylla™ MSI testing. Finally, we strengthened existing pharma collaborations and welcomed a new content partner, SkylineDx, Our first project with SkylineDx will focus on the development of an Idylla™ version of their Merlin Assay to help predict a patient’s risk of nodal metastasis in melanoma, which matches well with our existing Idylla™ BRAF Mutation Test (CE-IVD)4 for metastatic melanoma therapy guidance. Despite lingering uncertainties due to the pandemic, we continue to make progress on all fronts. We are well on track with our menu expansion plans, which will fuel further volume and revenue growth.” Q1 2021 HIGHLIGHTS Commercial cartridge volume: Year-over-year growth of 70%Better than expected performance in Europe, both in oncology and in infectious diseasesStrong growth in the US, driven by continued demand for the Idylla™ SARS-CoV-2 TestOncology volumes in distributor markets back on track and growing beyond expectations Idylla™ installed base: Continued expansion of Idylla™ installed base in line with expectations, led by European marketsUS laboratory operations not yet normalized, causing a slower than expected start of 2021 Idylla™ test menu: Encouraging reception and initial demand for the new Idylla™ GeneFusion Assay (RUO) which was launched end of March 2021First oncology assay US FDA submission with the 510(k) notification for the Idylla™ MSI Test to aid in the differentiation between sporadic colorectal cancer (CRC) and potential Lynch syndrome Partnerships: New partnership with SkylineDx for the development of SkylineDx’ novel proprietary Merlin Assay on Idylla™, aimed at predicting a patient’s risk of nodal metastasis in melanomaPartnership with Amgen reoriented towards the evaluation of the suitability of Biocartis technology as a potential companion diagnostic5 for an undisclosed research program. Due to the market need and opportunities in this area, both parties decided to discontinue their ongoing project in the colorectal cancer area aimed at PMA submission of the Idylla™ RAS tests with the US FDA and to resource the new high-priority feasibility assessment program Financial: End of Q1 2021, Biocartis’ cash position amounted to EUR 108.1m (unaudited figure). Commercial highlights Commercial cartridge volume – Strong start of the year in Q1 2021 with overall commercial cartridge volumes that grew 70% year-over-year. This was mainly driven by a higher than expected performance across European and distributor markets in oncology, supplemented by continued demand for the Idylla™ SARS-CoV-2 Test. In the US, after a strong finish of 2020, ordering volumes in oncology6 were pushed out towards the end of Q1 2021, but demand for the Idylla™ SARS-CoV-2 Test remained at attractive levels. While Idylla™ SARS-CoV-2 testing volumes fueled growth in Q1 2021, vaccination campaigns start to impact testing volumes, especially in the US where supply and demand start balancing out.Installed base – Overall, placements of new instruments tracked the expectations, in part driven by Idylla™ SARS-CoV-2 testing needs.Regulatory update distributor markets – During Q1 2021, the Idylla™ platform, the Idylla™ BRAF Mutation Test (CE-IVD) and the Idylla™ EGFR Mutation Test (CE-IVD) completed registration in Russia, and the Idylla™ MSI Test completed registration in Taiwan, as such expanding the distribution network for Biocartis’ IVD medical devices. Test menu and partnership highlightsDuring Q1 2021, Biocartis took important steps in the build-out of its oncology business. Idylla™ GeneFusion Assay – On 22 March 2021, Biocartis announced the long-awaited launch of its highly innovative Idylla™ GeneFusion Assay (RUO). The Assay detects, in one single cartridge, a wide range of biomarkers covering all gene fusions considered to be relevant in cancer research. The Idylla™ GeneFusion Assay (RUO) is therefore expected to provide a much faster testing solution for laboratories, compared to other testing methods including Next-Generation Sequencing (NGS) testing which often takes days or even weeks before results are available.US FDA submission Idylla™ MSI Test – On 20 April 2021, Biocartis announced its first oncology assay US FDA submission with the 510(k) submission7 of the Idylla™ MSI Test8 for use as an in vitro diagnostic device intended for the identification of microsatellite instability (MSI) status in colorectal (colon) cancer (CRC) to aid in the differentiation between sporadic CRC and potential Lynch syndrome. Partnership Amgen – After the reporting period, Biocartis and Amgen, a leading biotechnology company (NASDAQ: AMGN), agreed on initiating a feasibility assessment aimed at evaluating the suitability of Biocartis technology as a potential companion diagnostic for an undisclosed research program. Due to the market need and opportunities in this area, both parties decided to discontinue their ongoing project in the colorectal cancer area aimed at PMA submission of the Idylla™ RAS tests with the US FDA, and to resource the new high-priority feasibility assessment program.Partnership SkylineDx – After the reporting period, on 22 April 2021, Biocartis announced the signing of partnership agreement with SkylineDx, which targets the development of SkylineDx’ novel proprietary test, the Merlin Assay, on the Idylla™ platform and is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead commercialization in Europe through its growing Idylla™ network. As part of the agreement and based on SkylineDx' highly valuable portfolio of novel molecular tests in varying stages of development and expected attractive value-based pricing, Biocartis will invest up to EUR 10m in secured convertible notes to be issued by SkylineDx in different project-based instalments throughout the collaboration. Organizational and operational highlights Cartridge manufacturing – During Q1 2021, the transfer of the Idylla™ EGFR Mutation Test (CE-IVD) to the second cartridge manufacturing line (‘ML2’) was completed. This concluded the transfer of Biocartis’ main oncology assays on ML2, which is a key driver of cost optimizations within the Company’s cartridge manufacturing activities. Financial highlights Cash position – End of Q1 2021, Biocartis’ cash position amounted to EUR 108.1m (unaudited figure).Revised credit facility – During Q1 2021, Biocartis entered into a new credit facility with KBC Bank, replacing the facilities with KBC Bank and BNP Paribas Fortis that came to maturity in 2020. This facility consists of a EUR 7.5m straight loan and a EUR 7.5m rollover credit line. To date, the new credit facility remains undrawn. Outlook During Q1 2021, vaccination campaigns were initiated and the need for basic COVID-19 testing will most likely gradually reduce. Further normalization should favor oncology instrument installed base and cartridge growth, especially in the US. After summer, more typical seasonal viruses such as influenza and RSV may start spreading again as vaccination progresses and contact restrictions loosen. To address potential new testing needs and alleviate potential pressure on oncology testing volumes, Biocartis continues the development of the Idylla™ SARS-CoV-2/Flu/RSV Panel. Despite these continued uncertainties around the global development of the pandemic and its impact on molecular diagnostic testing both in oncology and in infectious diseases, Biocartis reconfirms its 2021 guidance: Commercial cartridge volume: Targeting a year-over-year growth of 40%-60% or commercial cartridge volumes in the range of 320k-370k. The high-end of the range will only be delivered in case of consistent strong demand for the Idylla™ SARS-CoV-2 Test or its successor the Idylla™ SARS-CoV-2 Panel at attractive average selling prices throughout 2021;Installed base: Targeting 300-350 new Idylla™ instrument placements; Cash position: Targeting at least EUR 50m cash position at year-end, including potential investments in upgrading and expanding the infectious diseases menu. Financial calendar 2021 14 May 2021 Annual and Extraordinary Shareholders’ Meetings Biocartis Group NV2 September 2021 H1 2021 results10 November 2021 Q3 2021 Business Update --- END --- More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-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 SARS-CoV-2 and sepsis. More information: www.biocartis.com. 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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. The Idylla™ SARS-CoV-2 Test, Idylla™ SARS-CoV-2/Flu/RSV Panel and SeptiCyte® RAPID contain SuperScript™ III Reverse Transcriptase and are provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation. The Idylla™ GeneFusion Assay contains SuperScript™ III Reverse Transcriptase and is provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation. Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents are under license from Cell Signaling Technology, Inc. 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 statementsCertain 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 In the US, distribution of the Idylla™ SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission. The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test2 Defined as the world excluding European direct markets, US, China and Japan3 RUO = Research Use Only, not for use in diagnostic procedures4 The Idylla™ BRAF Mutation Test, performed on the Idylla™ platform, is an in vitro diagnostic Test for the qualitative detection of V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene. The Idylla™ BRAF Mutation Test, from sample-to-result, starts with formalin-fixed paraffin-embedded (FFPE) human tissue from metastatic melanoma to liberate DNA for subsequent real-time PCR amplification and detection5 A CDx test is a test used as a companion to a therapeutic drug that helps predict if a patient is likely to respond to a treatment or not6 All Idylla™ assays sold in the US are for Research Use Only7 A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 24 March 20218 The Idylla™ MSI Test, for use on the Idylla™ system, is intended for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors and to aid in the differentiation between sporadic CRC and potential Lynch Syndrome. The clinical performance of this device to guide treatment of MSI-H patients has not been established. The Idylla™ MSI Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers and subsequent melt-curve analysis

  • GlobeNewswire

    Press release Biocartis Group NV: Biocartis and SkylineDx Sign Collaboration to Develop the Merlin Assay, a Test Predicting Risk for Nodal Metastasis in Melanoma, on Idylla™

    PRESS RELEASE: REGULATED-INSIDE INFORMATION22 April 2021, 07:00 CEST Biocartis and SkylineDx Sign Collaboration to Develop the Merlin Assay, a Test Predicting Risk for Nodal Metastasis in Melanoma, on Idylla™ Mechelen, Belgium, 22 April 2021 - Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), and SkylineDx, a Dutch (Rotterdam) and US (San Diego, California) based private biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases, today announce the signing of a new partnership agreement which targets the development of SkylineDx’ novel proprietary test, the Merlin Assay, on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™. This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network. Melanoma is the deadliest form of skin cancer1 and incidence rates are substantial in Europe with approx. 144k cases/year2, in the US with approx. 100k cases/year3 and in Australia with approx. 16,000 cases/year4. When diagnosed, prognosis and treatment decisions depend on disease staging5. Current staging methods include performing an SLN (sentinel lymph node) biopsy6, which is an invasive surgical intervention under general anesthesia, carrying a >10% risk of complications7. Moreover, 80-85% of SLN biopsies appear unnecessary as no nodal metastases are found8. The Merlin Assay aims to reduce the number of unnecessary SLN surgeries through the combination of gene expression (from the primary melanoma) with the patient’s age and tumor thickness, allowing the identification of patients at low risk of nodal metastasis8. As such, the Idylla™ Merlin Assay would provide a rapid and easy-to-use tool for physicians to identify patients who may safely forgo the SLN biopsy procedure. Today, the Merlin Assay is already available as a Laboratory Developed Test in SkylineDx’ CAP/CLIA laboratory in San Diego (California, US). For Europe, a molecular subtyping test kit for in vitro diagnostic use, mainly addressing centralized expert laboratories is under development and will be commercialized by Biocartis ahead of the Idylla™ version of the assay. Building on Idylla™’s decentralization capabilities, the Idylla™ version of the Merlin Assay will allow improved access for patients across Europe while reducing time to results. Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are excited about teaming up with SkylineDx to improve melanoma patient outcome and help clinicians, also in smaller, non-specialized lab settings, to rapidly and easily guide the true need for surgical removal of lymph nodes in melanoma patients. This Idylla™ Merlin Assay also connects well with our current oncology offering, where the Idylla™ BRAF Mutation Test (CE-IVD)9 can subsequently help to guide a patient’s treatment decisions in cases of metastatic melanoma.” Dharminder Chahal, Chief Executive Officer of SkylineDx, added: “Through this collaboration with Biocartis, we enable a broader availability of our test portfolio in melanoma. SkylineDx focuses on precision diagnostics for all cancer patients and with the addition of this new version of our Merlin Assay, more laboratories and care settings will be able to have access to this assay. Our teams are fully up to speed and we really look forward to start the development process together”. As part of the agreement and based on SkylineDx' highly valuable portfolio of novel molecular tests in varying stages of development and expected attractive value-based pricing, Biocartis will invest up to EUR 10m in secured convertible notes to be issued by SkylineDx in different project-based instalments throughout the collaboration. The initiation of the development of the Merlin Assay on Idylla™ is expected to start in 2021. ----- END ---- More information: BiocartisRenate Degrave, Head of Corporate Communications & Investor Relations Biocartise-mail rdegrave@biocartis.com tel +32 15 631 729 mobile +32 471 53 60 64 SkylineDx Marieke Spaan, Manager Corporate Affairs SkylineDxe-mail m.spaan@skylinedx.comtel +31 10 72 00 310mobile +31 6 42 66 51 73 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 SARS-CoV-2 and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_. About SkylineDxSkylineDx 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 US 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. To learn more on SkylineDx, please visit www.skylinedx.com. To learn more on the Merlin Assay and the overarching Falcon Melanoma R&D Program, please visit www.falconprogram.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 statementsCertain 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 Source: https://www.nccn.org/patients/guidelines/content/PDF/melanoma-patient.pdf, last consulted on 20 April 20212 Source: http://www.melanomapatientnetworkeu.org/melanoma.html, last consulted on 20 April 20213 National US Cancer Institute, https://seer.cancer.gov/statfacts/html/melan.html, last consulted on 20 April 20214 Source: Cancer Australia, https://www.canceraustralia.gov.au/affected-cancer/cancer-types/melanoma/melanoma-skin-statistics, last consulted on 20 April 20215 Crucial in determining disease stage is metastatic spread of cancerous cells to the sentinel lymph nodes (SLN)6 A sentinel lymph node biopsy (SLNB) is a surgical procedure used to determine whether cancer has spread beyond a primary tumor into the lymphatic system. Source: Mayo Clinic, https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/pac-20385264, last consulted on 20 April 20217 Ascha M, et al. Ann Plast Surg 79:509-515, 2017, https://journals.lww.com/annalsplasticsurgery/Abstract/2017/11000/Identification_of_Risk_Factors_in_Lymphatic.22.aspx8 Bellomo et al. JCO Precision Oncology, https://ascopubs.org/doi/10.1200/PO.19.002069 The Idylla™ BRAF Mutation Test, performed on the Idylla™ platform, is an in vitro diagnostic Test for the qualitative detection of V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene. The Idylla™ BRAF Mutation Test, from sample-to-result, starts with formalin-fixed paraffin-embedded (FFPE) human tissue from metastatic melanoma to liberate DNA for subsequent real-time PCR amplification and detection