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Biocartis Group N.V.. (4/4/23). "Press Release: Biocartis and APIS Assay Technologies Sign Collaboration to Develop and Commercialise a Breast Cancer Subtyping Test on the Idylla Platform". Mechelen.

Organisations Organisation Biocartis Group N.V. (Euronext Brussels: BCART)
  Group Biocartis (Group)
  Organisation 2 APIS Assay Technologies Ltd.
  Group APIS Assay Technologies (Group)
Products Product APIS Breast Cancer Subtyping Kit
  Product 2 Idylla™ molecular diagnostics system
Index term Index term Biocartis–APIS Assay Technologies: molecular diagnostics, 202304– collab developm + commerc APIS Breast Cancer Subtyping assay on Idylla platform
Persons Person Verrelst, Herman (Biocartis 202304– Board Chair before CEO before Agilent + Cartagenia + Medicim + Data4s)
  Person 2 Schorr, Joachim (APIS Assay Technologies 202304 CEO before Caris Life Sciences + Qiagen + Hoechst)

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
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

Record changed: 2024-01-20


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