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Press news Biocartis Group NV: Biocartis and GeneproDx To Collaborate on Fully Automated ThyroidPrint® test on Idylla™

Biocartis NV
·9-min read

PRESS RELEASE: 3 November 2020, 07:00 CET

Biocartis and GeneproDx To Collaborate on Fully Automated ThyroidPrint® test on Idylla™

Mechelen, Belgium, 3 November 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces it has signed a license, development and commercialization agreement with GeneproDx, a molecular diagnostics company based in Santiago, Chile, for the development of GeneproDx’s novel genomic test ThyroidPrint® on Biocartis’ rapid and easy to use molecular diagnostics platform Idylla™.

Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla™ ThyroidPrint® test, whereas Biocartis will be responsible for the distribution of the ThyroidPrint® on Idylla™ through its growing commercial infrastructure of Idylla™ instruments across the globe.

Thyroid nodules are very common and are often detected during routine medical exam or by patient self-assessment. Only some 10% of fine needle aspirate (FNA) biopsy procedures1 reveal the presence of malignant cells, while approximately 70% confirm a benign (non-cancerous) diagnosis. The remaining 20% are reported as indeterminate, meaning that no certain diagnosis can be provided to physician and patients2. Annually, over 1.2 million thyroid cytology evaluations are reported as indeterminate3. In patients with such result, diagnostic surgery of the thyroid gland is frequently recommended4. The risk of malignancy in these indeterminate cases is estimated to be between 15-35%, meaning that surgical intervention is unnecessary in up to 65-85% of these cases4.

ThyroidPrint® is a qRT-PCR5 based mRNA-expression classifier6 test that helps to determine whether a thyroid nodule with an indeterminate cytology result is benign or malignant7. A benign test result8 allows physicians to recommend watchful waiting as an alternative to diagnostic surgery. This prevents exposing patients to surgical risks and permanent thyroid hormone supplementation. Moreover, it significantly reduces health costs associated with unnecessary surgery3.

GeneproDx’s ThyroidPrint® was initially clinically validated in a multicenter trial in Chile, after which it was launched in Latin America3 in September 2018. Furthermore, the test was clinically validated in a second independent multicenter, prospective trial in the US in December 2019, demonstrating that ThyroidPrint® performs in the same manner in populations with different ethnicities and genetic backgrounds9. Currently, a new international validation study is ongoing, including an estimated 200 individuals with indeterminate cytology results10, in leading academic sites in Europe, the US and Latin-America.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very pleased to enter into a new collaboration where a high value gene signature test is ported on Idylla™. By developing an Idylla™ version of ThyroidPrint®, GeneproDx and Biocartis may enable broad availability of this test to laboratories and hospitals around the world, to help address this high clinical unmet need in thyroid patients. For Biocartis, this also means further expansion of the oncology menu into thyroid cancer.”

Hernán González MD, PhD, Professor of Surgery at the Pontifical Catholic University of Chile and Founder of GeneproDx, reacted: “As clinicians, an important challenge today is to determine whether a thyroid nodule is malignant and a patient really needs to undergo surgical resection of the thyroid gland. In our first real world clinical utility experience, ThyroidPrint® revealed a meaningful impact on the physician decision by reducing diagnostic surgery by more than 70% in patients with indeterminate cytology11. We are excited to use the rapid and easy-to-use Idylla™ technology to develop a ThyroidPrint® test that physicians can request to be performed in their local laboratories. As such, patients across the world can have the first of its kind, fast and easy-access diagnostic solution for indeterminate thyroid cytology results.”

Development of the ThyroidPrint® on Idylla™ will be initiated in Q4 2020.

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More information:
Biocartis
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


GeneproDx
Francisca Mena
Head of Corporate Communications GeneproDx
email fmena@geneprodx.com
tel +569 5608 654

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 tests for SARS-CoV-2 and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

About GeneproDx

GeneproDx’s mission is to offer patients with indeterminate thyroid nodules the highest quality of precision medicine through ThyroidPrint®. GeneproDx’s vision is to be pioneers and leaders in the diagnosis of patients with indeterminate thyroid nodules in Latin America, through permanent innovation and the highest quality standards. GeneproDx’s ThyroidPrint® is the first molecular test for indeterminate thyroid nodules clinically validated in Latin America and the US. More info on www.thyroidprint.com.


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. 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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. 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 In FNA biopsy procedures, approximately 350,000 of which are performed annually in the US alone (Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012;96(2):329-349. doi:10.1016/j.mcna.2012.02.002), cells are collected from the thyroid nodule for microscopic examination

2 Faquin WC, Bongiovanni M, Sadow PM 2011 Update in thyroid fine needle aspiration. Endocrine pathology 22:178‐183.

3 S. Vargas-Salas et al., Genetic testing for indeterminate thyroid cytology: review and meta-analysis, 2018, Endocrine-Related Cancer, https://erc.bioscientifica.com/

4 To determine the true nature of the nodule as standard practice. Haugen BRM, Alexander EK, Bible KC, Doherty G, Mandel SJ, Nikiforov YE, Pacini F, Randolph G, Sawka A, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward D, Tuttle RMM, Wartofsky L 2015 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid: official journal of the American Thyroid Association

5 Quantitative Reverse Transcription PCR. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: www.genome.gov, last consulted on 22 October 2020

6 Based on RTqPCR analysis, combined with an advanced machine learning algorithm

7 This means that the probability of the nodule being malignant drops from 25% to less than 5%, allowing follow-up to be recommended as an alternative to surgery. Info and source: https://thyroidprint.com/en/home-us/, last consulted on 22 October 2020

8 NPV (Negative Predictive Value) > 95%

9 M. Zafereo et al., A Thyroid Genetic Classifier Correctly predicts benign nodules with indeterminate cytology: two independent multicenter, prospective validation trials

10 Results are expected end of October 2021

11 Dominguez et al., ThyroidPrint: Preliminary Clinical Utility Experience. Archives of Endocrinol & Metab Vol 63, Suppl 02, pp 81 – 2019