Biocartis NV announced that its Idylla™ EGFR Mutation Test has received European Union Technical Documentation Assessment and Quality Management System certification under the European In Vitro Diagnostic Medical Device Regulation (IVDR), marking the first Idylla™ test to achieve Class C Companion Diagnostic (CDx) certification under the new regulatory framework.
Regulatory Milestone for Precision Oncology
The IVDR-certified test serves as a companion diagnostic for detecting EGFR exon 19 deletions and L858R mutations, critical biomarkers that guide targeted therapy selection for patients with non-small cell lung cancer (NSCLC). The certification confirms compliance with Europe's enhanced regulatory standards, ensuring improved patient safety, information transparency, and data traceability.
"Achieving IVDR certification for our Idylla™ EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence," said Roger Moody, Chief Executive Officer of Biocartis. "This is the first Idylla™ Test to be certified under the new IVDR framework, and we are currently pursuing certification of additional Tests in our portfolio."
Comprehensive Mutation Detection Platform
The test operates on the Idylla™ Platform and qualitatively detects 44 mutations across exons 18, 19, 20, and 21 of the EGFR gene within a single cartridge. While exon 19 deletions and L858R mutations are validated as CDx targets, the remaining mutations have undergone analytical validation. The system utilizes formalin-fixed, paraffin-embedded (FFPE) tissue samples and delivers fully automated sample-to-result processing.
The diagnostic platform demonstrates high analytical performance with 99.2% sensitivity (positive percent agreement) and 99.0% specificity (negative percent agreement) for the companion diagnostic targets. Results are available in under 3 hours, streamlining laboratory workflows and enabling rapid treatment decision-making for oncologists.
Market Availability and Strategic Partnerships
The IVDR-certified Idylla™ EGFR Mutation Test is now available to customers across Europe, with progressive availability expected in other non-US markets. Concurrently, Biocartis is developing the Idylla™ EGFR CDx Test for the US market in partnership with AstraZeneca. Upon regulatory approval, the test will identify NSCLC patients who may respond to treatment with Tagrisso® (Osimertinib), AstraZeneca's third-generation EGFR-TKI therapy.
Expanding Diagnostic Portfolio
The Idylla™ Platform represents a fully automated, real-time PCR-based system designed to provide in-house molecular biomarker testing capabilities. The platform's expanding menu of molecular diagnostic tests addresses clinical needs across multiple cancer types, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancers.
The IVDR framework establishes more stringent regulatory requirements compared to previous European diagnostic regulations, emphasizing enhanced clinical evidence and post-market surveillance. Biocartis' achievement of Class C certification under these elevated standards positions the company at the forefront of European diagnostic innovation while supporting the broader adoption of precision medicine approaches in oncology.
