PRESS RELEASE: REGULATED INFORMATION
BIOCARTIS MEETS 2020 KEY OBJECTIVES
Based on non-audited numbers,
- Installed base –
Biocartis placed 335 new Idylla™ instruments in 2020, exceeding the latest guidance of 300 new instrument placements. Biocartis’ installed base as per31 December 2020 increased to 1,581 Idylla™ instruments1. - Cartridge volume – In 2020,
Biocartis grew its commercial cartridge volume by 31%, slightly ahead of the latest guidance of 30%. In oncology, year-on-year growth both inEurope and in the US was largely offset by the distributor2 markets, but strong demand for the Idylla™ SARS-CoV-2 Test3 complemented overall volumes totaling 230k cartridges. - Cash position – As per
31 December 2020 , Biocartis’ cash4 position amounted toEUR 124m (non-audited number) versus the latest guidance ofEUR 120m .
Herman Verrelst, Chief Executive Officer of
In 2020,
- Expansion oncology partnerships – In 2020,
Biocartis launched several new partnerships to strengthen its oncology business:- In
January 2020 ,Biocartis signed a master collaboration agreement with lung cancer targeted therapy leader AstraZeneca aimed at rapid and easy testing and expanded its partnership to, amongst others, the area of liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay; - In
March 2020 ,Biocartis expanded its partnership with Bristol-Myers Squibb Company (NYSE: BMY), to now also pursue, after the US, the registration of the Idylla™ MSI test as a companion diagnostic (CDx) test5 in mCRC6 inChina ; - In
November 2020 ,Biocartis announced its entry in the thyroid cancer domain with the signing of a license, development and commercialization agreement with GeneproDx7 for the development of GeneproDx’ novel genomic test ThyroidPrint® on the Idylla™ platform.
- In
- Expansion infectious disease partnerships – Following amongst others the market shift due to the pandemic, in 2020,
Biocartis launched several new partnerships to gradually expand its infectious disease test menu:- In
March 2020 , the agreement withImmunexpress 8 was expanded with a co-commercialization agreement for the SeptiCyte® RAPID test for use on the Idylla™ platform; - In
September 2020 , the agreement withLifeArc 9 was expanded to now also develop highly innovative prototype assays in the field of infectious and immune related diseases on the Idylla™ platform; - In
October 2020 , the partnership with Bristol-Myers Squibb Company (NYSE: BMY) was expanded into the infectious disease domain with the announcement ofBiocartis joining theCOVID-19 Testing Industry Consortium , aimed at improving, innovating and accelerating all aspects of COVID-19 testing10; - In
November 2020 , a new partnership was signed withEndpoint Health 11 aimed at the development and commercialization of a novel CDx5 test on Idylla™ for critical illnesses.
- In
- Idylla™ test menu expansion –
Biocartis made further progress in its Idylla™ oncology test menu, with the development of its highly innovative Idylla™ GeneFusion Assay, expected to be launched as a RUO12 in Q1 2021, for which it announced to have received aEUR 1.2 million grant from VLAIO13 inSeptember 2020 . In the field of infectious disease,Biocartis announced inSeptember 2020 the market release of the SeptiCyte© RAPID test on Idylla™ (CE-IVD)14, followed by the CE-IVD launch of its Idylla™ SARS-CoV-2 Test3 inNovember 2020 . - Idylla™ publications – In 2020, several studies and abstracts once again demonstrated the excellent performance of Idylla™:
- In
September 2020 , the FACILITATE[15] study16, launched as part of the agreement betweenBiocartis and AstraZeneca (LON: AZN), was selected for presentation at the renownedEuropean Society for Medical Oncology (‘ESMO’)Virtual Congress 17; - In
November 2020 , at the annual meeting of the ‘Association for Molecular Pathology 18’ (AMP), ten Idylla™ studies were published which highlighted the strengths of the Idylla™ platform and assays19 in terms of performance, ease of use and turnaround time, as well as Idylla™’s capacity to overcome the obstacles of working with small amounts of sample20; - Also in
November 2020 , a global multi-centre real world study[21] with the Idylla™ MSI Assay was published and demonstrated excellent performance of the Idylla™ MSI Assay (RUO)12 with a very low failure rate. The study was the largest so far published forBiocartis .
- In
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More information:
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e-mail rdegrave@biocartis.com
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About
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 Excluding instruments returned by Exact Sciences in accordance with the termination agreement announced on
2 Defined as the world excluding European direct markets, US,
3 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),
4 Consisting of cash and cash equivalents
5 A companion diagnostic (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 not
6 Metastatic colorectal cancer
7 A molecular diagnostics company based in
8 A
9
10 Including research, regulatory oversight, clinical implications, reliability and access
11 A
12 RUO = Research Use Only, not for use in diagnostic procedures
13 The Flanders organization for Innovation & Entrepreneurship. The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and will be the first FFPE (formalin fixed, paraffin embedded) RNA based assay on the Idylla™ platform
14 Developed in collaboration with
15 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”,
16 A large, prospective, study across 16 European sites in
17 That took place between
18 A leading molecular diagnostics conference that took place virtually this year between
19 All studies were performed with Idylla™ RUO assays, research use only, not for use in diagnostic procedures. Three studies also discussed new
20 This represents a major challenge for many current molecular testing methods in a variety of different cancer types
21 A. Velasco et al., Multi-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer, Virchows Archiv, https://doi.org/10.1007/s00428-020-02962-x,
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