Tuesday November 8th 2022



Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the recent publication of a new, large prospective study (1) demonstrating that the Idylla™ EGFR Mutation Test (CE-IVD (2)) leads to the significant reduction of the time-to-treatment by 48% or on average 16.8 days faster than NGS testing for EGFR positive patients. This shows Idylla™’s potential to improve strategic treatment decisions within a multidisciplinary team for patients with advanced non-small cell lung cancer (NSCLC).

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “Tailoring cancer treatments to individual patients is key, and require molecular diagnostic testing to help identify the specific biomarkers involved. Recent studies (3) among approximately 1,600 patients show that in many European countries, less than 50% of the patients undergo biomarker testing. This is due to, among other reasons, lack of diagnostic laboratory infrastructure which also hinders a broader uptake of more complex testing technologies such as NGS. Integrating decentralized, rapid and easy-to-use Idylla™ testing in routine use can help broaden access to biomarker testing and as such, improve patient treatment and outcomes. We are therefore very pleased with another study showing the significant impact of Idylla™ on time-to-treatment that is no less than 16.8 days faster than NGS for EGFR positive patients with advanced NSCLC.”

The study was performed on 238 samples which were tested both using an NGS panel (Oncopanel) and the Idylla™ EGFR Mutation Test (4). The study showed a concordance of 98.7% between the Idylla™ EGFR Mutation Test and the NGS panel. The lab turnaround time was faster for the Idylla™ EGFR Mutation Test by an average of 12.4 days. In the EGFR positive cohort, the Idylla™ EGFR Mutation Test led to a 48% reduction and on average 16.8 days faster turnaround time.

Furthermore, the study concludes that the Idylla™ EGFR Mutation Test could contribute to overall time and cost savings for patients if testing is implemented in a stepwise manner, where the Idylla™ EGFR Mutation Test and the PD-L1 IHC (Immunohistochemistry) test are performed first, and comprehensive yet more expensive NGS panel testing is only initiated in case of a negative Idylla™ EGFR Mutation Test. Such first-line use of Idylla™ EGFR Mutation Test is not only more cost-effective, but it also allows to obtain EGFR test results in the same time frame as the PD-L1 IHC test results, which is important as EGFR positivity may be a contra-indication for PD-1/PD-L1 therapy in NSCLC (5).

The impact of the rapid Idylla™ EGFR Mutation Test on turnaround times is in line with previous studies (6) published, concluding that Idylla™ testing early on may contribute to improving strategic treatment decisions in a multidisciplinary team for patients with NSCLC by the early screening of EGFR mutations.

(1) Banyi N, Alex D, Hughesman C, McNeil K, N Ionescu D, Ma C, Yip S, Melosky B. Improving Time-to-Treatment for Advanced Non-Small Cell Lung Cancer Patients through Faster Single Gene EGFR Testing Using the Idylla™ EGFR Testing Platform. Curr Oncol. 2022 Oct 18;29(10):7900-7911. doi: 10.3390/curroncol29100624. PMID: 36290901

(2) The Idylla™ platform is cleared in the US under K163628. Idylla™ EGFR assay is for Research Use Only in the United States, not for use in diagnostic procedures. For more information, go to https://www.biocartis.com/en-US

(3) Normanno N, Apostolidis K, Wolf A, Al Dieri R, Deans Z, Fairley J, Maas J, Martinez A, Moch H, Nielsen S, Pilz T, Rouleau E, Patton S, Williams V. Access and quality of biomarker testing for precision oncology in Europe. Eur J Cancer. 2022 Oct 1;176:70-77. doi: 10.1016/j.ejca.2022.09.005. Epub ahead of print. PMID: 36194905

(4) For each patient, the time that the lab received the sample, the time taken to report the NGS and Idylla™ testing results, the time of first treatment and the final treatment regimen were taken into account

(5) J. Mazieres et al. Immune checkpoint inhibitors for patients with advanced lung cancer and oncogenic driver alterations: results from the IMMUNOTARGET registry. Annals of Oncology 2019

(6) Including Petiteau C, Robinet-Zimmermann G, Riot A, Dorbeau M, Richard N, Blanc-Fournier C, Bibeau F, Deshayes S, Bergot E, Gervais R, Levallet G. Contribution of the IdyllaTM System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations. Curr Oncol. 2021 Nov 3;28(6):4432-4445. doi: 10.3390/curroncol28060376. PMID: 34898548; PMCID: PMC8628756; Finall A, Davies G, Jones T, et al. J Clin Pathol Epub ahead of print. doi:10.1136/ jclinpath-2021-207987