Press Release Biocartis Group NV: Four Abstracts Showing Excellent Data for Idylla Presented at European Society of Molecular Oncology Congress (ESMO)
Press Release Biocartis Group NV: Four Abstracts Showing Excellent Data for Idylla Presented at European Society of Molecular Oncology Congress (ESMO)
PRESS RELEASE 20 October 2023, 07:00 CEST
新聞稿 2023 年 10 月 20 日，美國中部標準時間 07:00
Four Abstracts Showing Excellent Data for Idylla Presented at European Society of Molecular Oncology Congress (ESMO)
四份摘要展示了 Idylla 的精彩數據 在歐洲分子腫瘤學會大會（ESMO）上發表
Mechelen, Belgium, 20 October 2023 – Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company, announces that four study abstracts on Idylla have been selected for poster presentations at the international ESMO (European Society of Molecular Oncology) congress, taking place between 20-24 October 2023 in Madrid (Spain). The studies show excellent data for the Idylla GeneFusion Assay and Idylla EGFR Mutation Assay.
比利時梅赫倫， 2023 年 10 月 20 日 — 創新分子診斷公司Biocartis Group NV（“公司” 或 “Biocartis”）宣佈，在2023年10月20日至24日於西班牙馬德里舉行的國際ESMO（歐洲分子腫瘤學會）大會上，四份關於艾迪拉的研究摘要已入選海報展示。研究顯示，Idylla GeneFusion測定和Idylla EGFR突變測定的數據非常好。
Three studies demonstrate that the Idylla GeneFusion and EGFR Mutation Assays offer a rapid, sensitive and specific method for lung sample profiling in routine practice.
三項研究表明，Idylla GeneFusion和EGFR突變測定爲常規實踐中的肺部樣本分析提供了一種快速、靈敏和特異的方法。
- The first study1 prospectively tested lung cancer samples on the Idylla Platform as part of routine2 lung profiling locally and from over 60 UK hospitals. The investigators tested over 5,000 cases and demonstrated that the Idylla GeneFusion Assay had the expected rate of positivity and a low failure rate. Moreover, the Assay allowed testing to be successfully completed in samples unsuitable for NGS due to low tumor burden.
- The second abstract3 presents the results of a multicenter study that was conducted in a routine clinical2 setting involving 12 clinical centers across Europe. Providing high sensitivity and specificity values for all biomarkers, together with a low failure rate and rapid turnaround time (within 3 hours), the investigators concluded that the Idylla GeneFusion Assay technology has emerged as a highly relevant, time efficient and upfront screening tool on FFPE samples.
- The third abstract4 presents the results of the ORIGEN study, a multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain (in collaboration with AstraZeneca Spain). The investigators demonstrated a 15% frequency of EGFR mutations, with the most frequent being exon 19 deletions and the presence of the L858R mutation, which is in line with other data reported in Spain in advanced NSCLC. These results reinforce the importance of performing EGFR testing in early-stage NSCLC to predict the most appropriate treatment options.
- 第一項研究1 作爲常規活動的一部分，在 Idylla 平台上對肺癌樣本進行了前瞻性測試2 本地和英國60多家醫院的肺部分析。研究人員測試了5,000多例病例，並證明Idylla GeneFusion測定具有預期的陽性率和較低的失敗率。此外，由於腫瘤負擔較低，該測定允許成功完成對不適合NGS的樣本的檢測。
- 第二份摘要3 介紹了一項在常規臨床中進行的多中心研究的結果2 該項目涉及歐洲各地的12個臨床中心。研究人員得出的結論是，Idylla GeneFusion Assay技術爲所有生物標誌物提供了很高的靈敏度和特異性值，同時故障率低，週轉時間短（3小時內），他們得出的結論是，Idylla GeneFusion Assay技術已成爲一種高度相關、省時且預先篩選FFPE樣本的工具。
- 第三份摘要4 介紹了ORIGEN研究的結果，這是一項關於患病率的多中心研究 EGFR 西班牙早期可切除非小細胞肺癌患者的基因突變（與西班牙阿斯利康合作）。研究人員證明，表皮生長因子突變的頻率爲15％，最常見的是19外顯子缺失和存在 L858R 突變，這與西班牙在晚期非小細胞肺癌中報告的其他數據一致。這些結果凸顯了在早期非小細胞肺癌中進行表皮生長因子生長因子檢測以預測最合適的治療方案的重要性。
The fourth abstract5 describes a research project that aims to identify the feasibility of the Idylla GeneFusion Assay in detecting RET fusions in Papillary Thyroid Cancer (PTC).
第四份摘要5 描述了一個研究項目，該項目旨在確定Idylla GeneFusion測定在甲狀腺乳頭狀癌（PTC）中檢測RET融合的可行性。
Roger Moody, Chief Executive Officer of Biocartis, commented: "I am proud that independent researchers confirm the excellent performance of our products, especially the studies on the Idylla GeneFusion Assay, which demonstrates that this assay can be valuable for various cancer indications. The confirmation of the low invalid rates of our products in combination with their fast time to result, are a confirmation of the benefits of our Idylla Platform compared to other technologies such as NGS."
Biocartis首席執行官羅傑·穆迪評論說： “令我感到自豪的是，獨立研究人員證實了我們產品的卓越性能，尤其是Idylla GeneFusion Assay的研究，這表明這種測定對於各種癌症適應症可能很有價值。與NGS等其他技術相比，我們的Idylla Platform的優勢得到證實，其無效率很低，再加上它們快速得出結果。”
The four study abstracts on Idylla which have been selected for ESMO, can be downloaded here:
入選ESMO的四份關於Idylla的研究摘要可以在這裏下載：
--- END ---
---結束---
More information:
更多信息：
Investor Relations Biocartis
e-mail ir@biocartis.com
投資者關係 Biocartis
電子郵件 ir@biocartis.com
About Biocartis
關於 Biocartis
With its revolutionary and proprietary Idylla Platform, Biocartis (Euronext Brussels: BCART) aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, convenient, fast and suitable for any lab. The Idylla Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house access to accurate molecular information in a minimum amount of time for faster, informed treatment decisions. Idylla's continuously expanding menu of molecular diagnostic tests address key unmet clinical needs, with a focus in oncology. This is the fastest growing segment of the molecular diagnostics market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast and liver cancer, as well as for sepsis. More information: . Follow us on X (Twitter): @Biocartis_.
Biocartis（布魯塞爾泛歐交易所：BCART）憑藉其革命性的專有Idylla平台，渴望通過分子檢測的普及，使分子檢測具有可操作性、方便、快速且適用於任何實驗室，從而爲世界各地的患者提供個性化醫療。Idylla Platform 是一個基於全自動樣本到結果、實時 PCR（聚合酶鏈反應）的系統，旨在讓內部在最短的時間內訪問準確的分子信息，從而更快、更明智地做出治療決策。Idylla不斷擴大的分子診斷測試菜單可滿足尚未滿足的關鍵臨床需求，重點是腫瘤學。這是全球分子診斷市場中增長最快的細分市場。如今，Biocartis提供支持黑色素瘤、結直腸癌、肺癌、乳腺癌和肝癌以及敗血症的檢測。更多信息： 。 繼續關注我們 X (Twitter): @Biocartis_。
Idylla Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, cleared for sales in the US and registered in many others countries. 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.
Idylla Platform在歐洲獲得CE認證，符合歐盟體外診斷法規2017/746號，已獲准在美國銷售，並在許多其他國家註冊。Biocartis和Idylla是歐洲、美國和其他國家的註冊商標。Biocartis和Idylla的商標和徽標是Biocartis擁有的二手商標。請參閱產品標籤，了解每款 Biocartis 產品的適用預期用途。
本新聞稿不得在任何非法的司法管轄區直接或間接發佈。任何閱讀本新聞稿的人都應了解並遵守任何此類限制。Biocartis對任何人違反任何此類限制不承擔任何責任。本新聞稿不構成在任何司法管轄區出售或購買證券的要約或邀請。除非在美國證券交易委員會註冊或根據經修訂的1933年美國證券法獲得註冊豁免，否則不得在美國發行或出售Biocartis的證券。
Forward-looking statements
前瞻性陳述
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.
本新聞稿中的某些陳述、信念和觀點具有前瞻性，反映了公司或酌情反映了公司董事或管理層對未來事件的當前預期和預測，例如公司的經營業績、財務狀況、流動性、業績、前景、增長、戰略和公司運營所在行業。就其性質而言，前瞻性陳述涉及許多風險、不確定性、假設和其他因素，這些因素可能導致實際結果或事件與前瞻性陳述所表達或暗示的結果或事件存在重大差異。這些風險、不確定性、假設和因素可能會對本文所述計劃和事件的結果和財務影響產生不利影響。多種因素，包括但不限於需求、競爭和技術的變化，都可能導致實際事件、業績或結果與任何預期的發展有顯著差異。本新聞稿中包含的有關過去趨勢或活動的前瞻性陳述不能保證未來的業績，也不應視爲此類趨勢或活動將在未來持續下去。此外，即使實際業績或事態發展與本新聞稿中包含的前瞻性陳述一致，這些業績或事態發展可能並不代表未來時期的業績或發展。對此類前瞻性陳述的準確性或公平性不作任何陳述和保證。因此，除非法律或法規特別要求，否則公司明確表示沒有義務或承諾因預期的任何變化或這些前瞻性陳述所依據的事件、條件、假設或情況的任何變化而發佈對本新聞稿中任何前瞻性陳述的任何更新或修訂。公司及其顧問或代表、其任何子公司或任何此類人員的高級管理人員或僱員均不保證此類前瞻性陳述所依據的假設沒有錯誤，也不對本新聞稿中包含的前瞻性陳述的未來準確性或預測事態發展的實際發生承擔任何責任。您不應過分依賴前瞻性陳述，前瞻性陳述僅代表截至本新聞稿發佈之日。
1 First study. 1307P - The Biocartis Idylla GeneFusion Assay (RUO) for lung cancer testing: The experience of testing over 5000 tumours in routine practice. Presentation Number: 1307P. Speakers: Lee Robertson (Birmingham, United Kingdom). Onsite Poster display date: Saturday, 21 October 2023.
2 Biocartis NV can supply A0120/6 Idylla GeneFusion Panel, which is a CE-marked product according to the IVD directive 98/79/CE.
3 Second study. 1430P - Excellent performance of a fast and fully-automated RNA based genefusion assay conducted on a large fusion positive non-small cell lung cancer cohort within a multicenter study. Presentation Number: 1430P. Speakers: Arndt Hartmann (Erlangen, Germany). Onsite Poster display date: Monday, 23 October 2023.
4 Third study. 1278P - ORIGEN: Multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain. Presentation Number: 1278P. Speakers: Ernest Nadal (L'Hospitalet de Llobregat, Spain). Onsite Poster display date: Saturday, 21 October 2023.
5 Fourth study. 2223P - Next-generation sequencing enables identification of RET rearrangements in papillary thyroid cancer. Presentation Number: 2223P. Speakers: Sergi Clavé (Barcelona, Spain). Onsite Poster display date: Sunday, 22 October 2023.
1 第一項研究。1307P——用於肺癌檢測的Biocartis Idylla GeneFusion測定（RUO）：在常規實踐中測試5000多種腫瘤的經驗。演示文稿編號：1307P。演講者：李·羅伯遜（英國伯明翰）。現場海報展示日期：2023 年 10 月 21 日（星期六）。
2 Biocartis NV可以提供A0120/6 Idylla GeneFusion Panel，根據體外診斷指令98/79/CE，這是一款經過CE認證的產品。
3 第二項研究。1430P——在一項多中心研究中，對大型融合陽性非小細胞肺癌隊列進行的基於RNA的快速全自動基因融合測定表現出色。演示文稿編號：1430P。演講者：阿恩特·哈特曼（德國埃爾蘭根）。現場海報展示日期：2023年10月23日星期一。
4 第三項研究。1278P——ORIGEN：關於西班牙早期可切除非小細胞肺癌患者表皮生長因子基因突變患病率的多中心研究。演示文稿編號：1278P。演講者：歐內斯特·納達爾（西班牙略佈雷加特河畔奧斯皮塔萊特）。現場海報展示日期：2023 年 10 月 21 日（星期六）。
5 第四項研究。2223P——下一代測序可以識別甲狀腺乳頭狀癌中的RET重排。演示文稿編號：2223P。演講者：塞爾吉·克拉夫（西班牙巴塞羅那）。現場海報展示日期：2023年10月22日（星期日）。
譯文內容由第三人軟體翻譯。