Tele: 561.316.3330
Breaking Medical Device News

Thursday, October 21, 2021


HomeBiocartis Group NV: Study Demonstrates Ability of Idylla(TM) EGFR Mutation Test to...

Biocartis Group NV: Study Demonstrates Ability of Idylla(TM) EGFR Mutation Test to Produce a Result in 80% of Failed Next Generation Sequencing Lung Cancer Tests

May 28, 2018

Biocartis Group NV ), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of a study[1] in the Journal of Clinical Pathology demonstrating that the Idylla(TM) EGFR Mutation Test (CE-IVD) was able to rescue 80% of the EGFR samples whose assessment was unsuccessful with Next Generation Sequencing (NGS).

Biocartis Group reports the study concluded that the Idylla(TM) EGFR Mutation Test is a viable alternative to NGS for rapid treatment decisions[2] in patients with acute deterioration, in particular when testing is performed on a less than optimal tumor tissue sample, which frequently yields insufficient amounts of DNA for proper NGS analysis.

The study, conducted by amongst others Prof. Giancarlo Troncone, Professor of Anatomic Pathology of the Department of Public Health, University of Naples Federico II (Naples, Italy) and Prof. Massimo Barberis, Director of Histopathology and Molecular Diagnostics Unit of the Division of Pathology and Laboratory Medicine, Istituto Europeo di Oncologia (Milan, Italy), included 68 archival DNA samples previously processed by NGS[3]. A total of 43 had a valid NGS result and 25 (37%) had an invalid NGS result. These samples were retested by directly pipetting[4] the DNA[5] into the Idylla(TM) EGFR Mutation Test cartridge.

There was a 100% concordance with NGS for the valid results, where Idylla(TM) confirmed the EGFR mutational status. For a large portion (20/25 or 80%) of the cases whose NGS assessment was invalid, Idylla(TM) was able to process the sample and adequately produced a result. In 4/25 (16%) of these cases, Idylla(TM) detected actionable EGFR mutations, which means a larger patient population that could potentially benefit from targeted treatments.

Lung cancer testing today is often complex because of the limited amount of lung cancer tissue available, which frequently leads to failure of test results. The Idylla(TM) EGFR Mutation Test is performed on Biocartis’ Idylla(TM) system and allows the detection of 51 EGFR mutations, which are included in international guidelines[6] for all patients with advanced NSCLC[7] of a non-squamous subtype, directly from only one slice of FFPE[8] tumor tissue. The test delivers results in approx. 2.5 hours with less than 2 minutes hands-on time.

Giancarlo Troncone, MD, PhD, Professor of Anatomic Pathology, University of Naples Federico II (Naples, Italy), commented: “Timely communication between oncologists and molecular pathologists is crucial, in particular for acute deteriorating patient clinical management. Our data showed that, when clinical decisions should be taken quickly to save time since days have been spent on waiting for an invalid NGS result, Idylla(TM) can provide a solution.”

Lung cancer is the cancer with the highest incidence worldwide[9]. The launch of Biocartis’ fully automated Idylla(TM) liquid biopsy ctEGFR Mutation Assay (RUO[10]) is planned for H2 2018.


[1] De Luca et al, University of Naples Federico II, “The Idylla(TM) Assay and Next Generation Sequencing: an integrated EGFR mutational testing algorithm”, Journal of Clinical Pathology, to consult online on, 24 May 2018.

[2] To be taken by a multidisciplinary team.

[3] Ion Torrent NGS Assay by Thermo Fisher Scientific Inc, USA.

[4] Cases with a valid NGS result were tested by pipetting 3 microliter of DNA (corresponding to 1/10th of the original DNA preparation from the sample) in the Idylla(TM) EGFR Mutation Test cartridge. Whenever possible, in NGS invalid cases the pipetted DNA volume was increased up to 10 microliter of extracted DNA. It was previously shown that archival extracted DNA can directly be pipetted inside an Idylla(TM) EGFR Mutation Test cartridge: Source: De Luca et al., “EGFR mutation on lung cancer cytological specimens by the novel fully automated PCR-based Idylla(TM) EGFR Mutation Assay”, J Clin Pathol. 2017; 70:295-300.

[5] Biocartis has not validated this sample type for clinical use with its Idylla(TM) EGFR Mutation Test (CE IVD).

[6] NCCN Clinical Practice Guidelines in Oncology – NSCLC – Version 3.2018, and Novello S. et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2016.

[7] Non-small cell lung cancer

[8] Formalin fixed, parrafin embedded.


[10] RUO = Research Use Only.


Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy