PRESS RELEASE: 4 April 2023, 07:00 CEST
Biocartis and APIS Assay Technologies Sign Collaboration to Develop and Commercialise a Breast Cancer Subtyping Test on the Idylla platform
Mechelen, Belgium, 4 April 2023 - Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), and APIS Assay Technologies Ltd., a private UK based company specializing in molecular diagnostics, today announce that they have entered into a new partnership agreement which targets the development of APIS' Breast Cancer Subtyping assay on Biocartis' rapid and easy-to-use molecular diagnostics platform Idylla.
Under the terms of the partnership agreement, APIS will lead the development of the Breast Cancer Subtyping test on Idylla, while Biocartis will lead the commercialisation through its growing Idylla network.
Breast cancer is the most commonly diagnosed cancer among women, accounting for 11.7% of all cancer cases globally1. In 2020, it was estimated that there were over 2.2 million new cases of breast cancer worldwide1. Invasive breast cancer is classified into distinct categories with differing tumour behaviour and prognosis2. Based on the expression of hormone receptors that are present in breast cancer cells (HER2, ER, PR)3 and a proliferation marker (Ki67)4, the main molecular subtypes of invasive breast cancer can be distinguished.5 The presence or absence of these markers can guide the selection of appropriate treatment options. ER and PR are important indicators of how well a breast cancer tumour will respond to hormone therapy. HER2, on the other hand, is an important predictor of response to targeted therapy, such as trastuzumab6. The detection of these markers is routinely performed with IHC7.
APIS' current Breast Cancer Subtyping Kit is an RNA-based diagnostic assay for detecting mRNA expression of standard biomarkers (HER2, ER, PR, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumour tissue. The test aims to address a number of unmet needs in current practice, including improving reproducibility and accuracy in the Ki67 proliferation measurement and assessment of low HER2 expression status. The latter is especially important as recent studies have shown HER2-low patients to be responsive to a new category of HER2 targeting therapies.8,9
Currently, the APIS Breast Cancer Subtyping Kit is available as a manual kit for in vitro diagnostic use10, mainly addressing centralized expert laboratories. The kit is currently offered by APIS in the UK and will be broadly commercialised11 by Biocartis ahead of the Idylla version of the assay becoming available. While the manual kit already offers a reduced time for results interpretation (as compared to current IHC based workflows), the Idylla version of the Breast Cancer Subtyping assay will further benefit from the workflow and decentralization advantages of the Idylla platform. This is expected to allow for the fastest time to results and for improved access to the most accurate biomarker results for patients worldwide.
Herman Verrelst, Chief Executive Officer of Biocartis, commented: "We are excited about partnering with APIS Assay Technologies to improve molecular classification for breast cancer patients. The APIS team is highly experienced in IVD development and will lead the porting of the assay to our Idylla platform. Our sales team has become highly proficient in distribution of manual kits across its extensive laboratory network, while developing Idylla version of partner assays. The combination of the APIS Breast Cancer Subtyping test with the Idylla PIK3CA-AKT1 Mutation Assay that is under development will allow us to offer a complementary set of assays in the breast cancer domain."
Joachim Schorr, Chief Executive Officer of APIS Assay Technologies, added: "We are very much looking forward to our collaboration with the Biocartis team. The Idylla platform and its all-in-one cartridge-based tests provide an optimised, fully automated solution for fast and effective treatment selection for breast cancer patients. Furthermore, Biocartis' global presence will further allow our innovative solution to benefit breast cancer patients worldwide. The collaboration with Biocartis will provide the ability to perform Breast Cancer Subtyping analysis also directly in pathology labs utilising the Idylla platform's ease of use and integrated FFPE sample-to-result performance."
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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: . Follow us on Twitter: @Biocartis_,Facebook or LinkedIn
About APIS
APIS is leveraging systems biology, interrogating multi-OMICs biodata, and deploying innovative 'Clickmer' ligand binding technology, for the validation and translation of biomarker and therapeutic assets into clinical utility. APIS has deep expertise and capabilities in IVD development of molecular & immune assays for ultimate product realization as diagnostic tests. In addition, APIS' expertise in bioinformatics and software development is offered as an agile service to our clients, to develop bespoke, end-to-end multi-OMICs solutions and platform development. The new APIS Breast Cancer Subtyping Kit is a highly reproducible, RT-qPCR based IVD product (in certain territories10) and RUO product for detecting standard (HER2, ER, PR, Ki67) and novel proliferative biomarkers. The results of this assay can help direct clinicians to the right treatment, more quickly, with higher accuracy. For more information, visit or follow APIS on Twitter @ApisAssay or LinkedIn.
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 WHO Globocan;
2 13th St. Gallen International Breast Cancer Conference 2013, Expert panel consensus opinion
3 ER: estrogen receptor, PR: progesterone receptor, HER2: human epidermal growth factor receptor 2
4 Ki67: marker of proliferation Ki-67
5 Four main molecular subtypes: Luminal A, Luminal B, HER2, and Basal-like (triple negative)
6 Trastuzumab, sold among others under the brand name Herceptin, is a monoclonal antibody used to treat HER2-positive breast cancer
7 IHC or Immunohistochemistry is a laboratory method that uses antibodies to check for certain antigens (markers) in a sample of tissue. Source:
8 Trastuzumab:deruxtecan (Enhertu), an antibody-drug conjugate, is the first HER2-directed therapy approved for patients with HER2-low metastatic breast cancer
9 Nicolò et al. The HER2-low revolution in breast oncology: steps forward and emerging challenges Ther Adv Med Oncol (2023) 15: 17588359231152842
10 Registered as IVD in the UK, awaiting CE marking under EU IVD Regulation
11 In the European Union and selected export markets
新聞稿:2023年4月4日07:00 CEST
Biocartis和原料藥檢測技術簽署合作協定開發和開發商業%se一種乳腺癌亞型檢測方法在Idylla上站臺
比利時梅赫倫,4月4日2023--一家創新的分子診斷公司Biocartis Group NV(“公司”或“Biocartis”)和一家總部設在英國的私營分子診斷公司APIS Assay Technologies Ltd.今天宣佈,他們已經簽訂了一項新的合作協定,目標是在Biocartis的快速和易於使用的分子診斷平臺Idylla上開發APIS的乳腺癌亞型分析。
根據合作協定的條款,API將領導Idylla上乳腺癌亞型測試的開發,而Biocartis將通過其不斷增長的Idylla網路領導商業化。
乳腺癌是女性中最常見的癌症,佔全球癌症病例的11.7%1。據估計,2020年全球新增乳腺癌病例超過220萬例1。浸潤性乳腺癌被分為不同的類型,具有不同的腫瘤行為和預後。2.。根據乳腺癌細胞(HER2,ER,PR)中存在的激素受體的表達3和增殖標記物(Ki67)4,可以區分浸潤性乳腺癌的主要分子亞型。5這些標誌物的存在或不存在可以指導選擇適當的治療方案。ER和PR是衡量乳腺癌腫瘤對激素治療反應程度的重要指標。另一方面,HER2是靶向治療(如曲妥珠單抗)反應的重要預測指標6.。這些標誌物的檢測通常是用IHC進行的7。
APIS目前的乳腺癌分型試劑盒是一種基於RNA的診斷方法,用於檢測術前核心針活檢(CNB)或切除的福馬林固定石蠟包埋(FFPE)乳腺腫瘤組織中標準生物標記物(HER2、ER、PR、Ki67)和新的增殖生物標記物的mRNA表達。該測試旨在解決當前實踐中一些未得到滿足的需求,包括提高Ki67增殖測量的重複性和準確性,以及評估低HER2表達狀態。後者尤其重要,因為最近的研究表明,HER2低的患者對一種新的HER2靶向治療有反應。8,9
目前,API乳腺癌分型試劑盒以手動試劑盒的形式提供,用於體外診斷10,主要針對集中式專家實驗室。該試劑盒目前由英國的原料藥提供,並將廣泛商業化11.由Biocartis在Idylla版本的化驗方法面世之前進行。雖然手動試劑盒已經減少了結果解釋的時間(與當前基於IHC的工作流程相比),但Idylla版本的乳腺癌亞型分析將進一步受益於Idylla平臺的工作流程和權力下放優勢。預計這將允許最快的時間達到結果,並改善世界各地患者獲得最準確的生物標誌物結果的機會。
Herman Verrelst,Biocartis首席執行官,評論說:我們很高興能與APIS分析技術公司合作,改善乳腺癌患者的分子分類。APIS團隊在IVD開發方面經驗豐富,將領導將檢測移植到我們的Idylla平臺。我們的銷售團隊已經非常熟練地在其廣泛的實驗室網路中分發手動試劑盒,同時開發Idylla版本的合作夥伴分析。API乳腺癌分型測試與正在開發中的Idylla PIK3CA-AKT1突變檢測相結合,將使我們能夠在乳腺癌領域提供一套互補的檢測方法。“
原料藥檢測技術公司首席執行官Joachim Schorr,並補充說:“我們非常期待與Biocartis團隊的合作。Idylla平臺及其一體式墨盒-基於測試的測試提供了已優化,全自動解決方案,為乳腺癌患者快速有效地選擇治療方案。此外,Biocartis的全球業務將進一步使我們的創新解決方案受益於乳腺癌患者全世界。與Biocartis的合作將提供直接在病理實驗室進行乳腺癌亞型分析的能力利用Idylla平臺的易用性和集成的FFPE樣本到結果性能。
-完
更多資訊:
雷納特·德格雷夫
Biocartis公司公關和投資者關係主管
電子郵件:rdedeve@biocartis.com
電話:+32 15 631 729
行動電話:+32 471 53 60 64
關於Biocartis
Biocartis(泛歐交易所布魯塞爾股票代碼:BCART)是一家創新的分子診斷(MDX)公司,提供下一代診斷解決方案,旨在改善臨床實踐,造福患者、臨床醫生、付款人和行業。Biocartis專有的MDX Idylla平臺是一個完全自動化的從樣品到結果的實時聚合酵素鏈式反應(Polymerase Chain Reaction)系統,可以在幾乎任何環境下從幾乎任何生物樣本提供準確、高度可靠的分子資訊。Biocartis正在開發和營銷一種不斷擴大的測試菜單,以滿足關鍵的未得到滿足的臨床需求,重點放在腫瘤學上,這是全球MDX市場增長最快的部分。今天,Biocartis提供黑色素瘤、結直腸癌和肺癌以及新冠肺炎、流感、呼吸道合胞病毒和膿毒症的檢測。詳細資訊:。在Twitter上關注我們:@Biocartis_,Facebook或LinkedIn
關於API接口
API正在利用系統生物學,詢問多組學生物數據,並部署創新的“Clickmer”配基結合技術,以驗證生物標記物和治療資產,並將其轉化為臨床用途。APIS在IVD分子和免疫分析的開發方面擁有深厚的專業知識和能力,最終將產品實現為診斷測試。此外,API在生物資訊學和軟體開發方面的專業知識作為一種靈活的服務提供給我們的客戶,以開發定製的端到端多組學解決方案和平臺開發。新的API乳腺癌分型試劑盒是一種高度可重複性的、基於RT-qPCR的IVD產品(在某些地區10)和用於檢測標準(HER2、ER、PR、Ki67)和新的增殖生物標記物的RUO產品。這種檢測結果可以幫助臨床醫生更快、更準確地指導正確的治療。欲瞭解更多資訊,請訪問或關注Twitter@ApisAssay或LinkedIn上的API。
Biocartis和Idylla是在歐洲、美國和歐洲的註冊商標州政府和其他國家。Biocartis和Idylla商標和徽標是Biocartis擁有的商標。請參考產品標籤,瞭解每種生物卡特斯產品的適用目標用途。
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1誰是地球人;
2.2013年第13屆聖加倫國際乳腺癌會議,專家小組共識意見
3ER:雌激素受體,PR:孕激素受體,HER2:人表皮生長因數受體2
4Ki67:增殖標記物Ki-67
5四種主要的分子亞型:流明A、流明B、HER2和鹼基樣(三重陰性)
6.曲妥珠單抗以Herceptin的品牌出售,是一種用於治療HER2陽性乳腺癌的單抗
7IHC或免疫組織化學是一種使用抗體來檢查組織樣本中特定抗原(標記物)的實驗室方法。資料來源:
8曲妥珠單抗:Deuxtecan(Enhertu),一種抗體-藥物結合物,是第一個被批准用於HER2低轉移乳腺癌患者的HER2導向療法
9Nicolò等人的研究。乳腺腫瘤學的HER2-LOW革命:前進的步伐和新出現的挑戰--《內科雜誌》(2023年)15:17588359231152842
10在英國註冊為IVD,根據歐盟IVD法規等待CE標誌
11.在歐盟和選定的出口市場