PRESS RELEASE: REGULATED INFORMATION
Based on non-audited numbers,
- Installed base –
Biocartis placed 331 net new Idylla™ instruments in 2021, in line with the latest guidance of 300-350 new instrument placements. Biocartis’ installed base as per31 December 2021 increased to 1,912 Idylla™ instruments. - Cartridge volume – In 2021,
Biocartis sold 323k commercial cartridges, 40% more than in 2020 and in line with the latest guidance. Continued strong growth in oncology, was complemented by a consistent contribution of the Idylla™ SARS-CoV-2 tests1 and initial sales of SeptiCyte® RAPID on Idylla™. - Cash position – As per
31 December 2021 , Biocartis’ cash2 position amounted toEUR 53.5m (non-audited number) versus the latest guidance ofEUR 50m . The cash position includedEUR 6.0m drawn on short-term credit facilities. The cash burn for the year was in line with expectations, except for the insurance claim for fire damages that is not fully collected yet.
Herman Verrelst, Chief Executive Officer of
In 2021,
- Oncology:
- In March 2021,
Biocartis launched the Idylla™ GeneFusion Assay (RUO3) as a rapid lab workflow solution for gene fusion testing of ALK, ROS1, RET, NTRK 1/2/3, as well as MET exon 14 skipping which is increasingly used in research related to multiple cancer types including lung cancer, thyroid cancer and others; - In
April 2021 ,Biocartis announced its firstUS FDA submission of an oncology assay with the 510(k) submission4 of its Idylla™ MSI Test 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; - Also in
April 2021 ,Biocartis announced the signing of a partnership agreement with SkylineDx which targets the development of their novel proprietary test, the Merlin Assay, on the Idylla™ platform, which is aimed at predicting a patient’s risk of nodal metastasis in melanoma; - In
May 2021 ,Biocartis announced its expanded partnership with AstraZeneca to improve access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in European and global distributor markets5; - Also in
May 2021 ,Biocartis announced theEUR 1.4 million grant it received from VLAIO, the Flanders organization for Innovation & Entrepreneurship, for the ongoing development of a highly innovative technology to be deployed on the Idylla™ platform aimed at enabling the off-line customization of the Idylla™ cartridge.
- In March 2021,
- Infectious diseases:
- In
September 2021 ,Biocartis announced the launch of its Idylla™SARS-CoV2/Flu/RSV Panel (CE-IVD) which detects, in one single cartridge, SARS-CoV-2, Flu A/B and RSV6 nucleic acids, with results in approximately 90 minutes; - In
November 2021 ,Biocartis announced theUS FDA granted 510(k) clearance for SeptiCyte® RAPID7 (CE-IVD,US FDA 510(k)) which runs on the Idylla™ platform8 and was developed under the partnership withImmunexpress 9. The SeptiCyte® RAPID is a fully automated, rapid host-response test10 that distinguishes sepsis from infection negative systemic inflammation in patients suspected of sepsis, providing actionable results in approximately 1 hour, enabling physicians to optimize patient management decisions; - In
December 2021 ,Biocartis announced the successful performance of an in-silico analysis concluding that the Idylla™ SARS-CoV-2 Test (CE-IVD) and Idylla™SARS-CoV-2/Flu/RSV Panel (CE-IVD) are both able to detect the B.1.1.529/Omicron sequences, the latest variant of concern causing COVID-19 disease.
- In
- Idylla™ publications – In 2021, Idylla™’s excellence along with the performance of Idylla™’s EGFR11 testing solutions was emphasized through several studies and abstracts:
- In
February 2021 ,Biocartis announced the publication of two studies12 byMemorial Sloan Kettering Cancer Center (‘MSKCC’,New York , US) on the use of Biocartis’ Idylla™ EGFR Mutation Assay (RUO) as a rapid first-line testing method before using next-generation sequencing (NGS). Both studies concluded that Idylla™ EGFR testing enables rapid assessment of the most common EGFR mutations with low sample input, even on different sample types, without compromising subsequent more comprehensive NGS testing13; - In
November 2021 ,Biocartis announced the publication of a study14 which concluded that the Idylla™ platform contributes to improving patient management decisions for patients with non-small cell lung cancer (NSCLC) through the faster screening of EGFR mutations.
- In
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More information:
Head of
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
About
Idylla™ GeneFusion Assay, Idylla™ SARS-CoV-2 Test, Idylla™ SARS-CoV-2/Flu/RSV Panel and SeptiCyte® RAPID on Idylla™: 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 under license from
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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 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),
2 Consisting of cash and cash equivalents
3 Research Use Only, not for use in diagnostic procedures
4 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
5 Defined as the world excluding European direct markets, US,
6 Respiratory Syncytial Virus
7 SeptiCyte® RAPID is developed by
8 The Idylla™ Instrument and Idylla™ Console have been exempted by the
9
10 Host-response based tests focus on measuring biomarkers that are indicative of the response of a patient’s immune system to an infection rather than measuring pathogens that are the cause of the infection
11 EGFR or ‘Epidermal growth factor receptor’ mutations are the second most common oncogenic driver in non-small cell lung cancer (NSCLC)
12 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation Screening Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Clinical and Research Reports (2020), doi: https://doi.org/10.1016/j.jtocrr.2020.100077., available online
13 Which can be useful in cases where EGFR mutation results were negative and further testing is needed
14 Petiteau, C.; Robinet-Zimmermann, G.; Riot, A.; Dorbeau,M.; Richard, N.; Blanc-Fournier, C.; Bibeau, F.; Deshayes, S.; Bergot, E.; Gervais, R.; et al. Contribution of the Idylla™ System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations. Curr. Oncol. 2021, 28, 4432–4445. https://doi.org/10.3390/curroncol28060376, published
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