Biocartis’ Idylla EGFR Mutation Test has secured the EU Technical Documentation Assessment and Quality Management System certificate, making it the first Idylla Test to achieve Class C companion diagnostic (CDx) in vitro medical device status.
This certification was granted under the In Vitro Diagnostic Medical Device Regulation (IVDR).
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According to the company, the Idylla EGFR Mutation Test is specifically tailored to identify mutations associated with non-small cell lung cancer (NSCLC), aiding in the selection of targeted therapies.
This certification is said to attest to the test’s adherence to the EU’s new IVDR standards, which aim to improve patient safety and data integrity.
Biocartis CEO Roger Moody said: “Achieving IVDR certification for our Idylla EGFR Mutation Test is a key milestone for Biocartis and reinforces our commitment to quality and regulatory excellence.
“The IVDR establishes more rigorous standards to improve patient safety and diagnostic accuracy, and we are proud to be at the forefront of this evolution in European diagnostics.”
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By GlobalDataIntended for use on the Idylla Platform, the test claims to identify 44 mutations across four exons of the epidermal growth factor receptor (EGFR) gene using one cartridge.
This includes exon 19 deletions and the L858R mutation, which are critical biomarkers for guiding NSCLC treatments. The remaining mutations have undergone analytical validation.
Leveraging formalin-fixed, paraffin-embedded tissue samples, the EGFR Mutation Test offers a fully automated process, from sample to outcome.
Results are said to be delivered in less than three hours, allowing for rapid treatment decisions. The test claims to have a 99.2% sensitivity and 99% specificity for the CDx targets.
Currently, it is available in Europe, with plans to expand to other non-US markets.
In the US, Biocartis is collaborating with AstraZeneca to develop the Idylla EGFR CDx Test, which, upon approval, will be used to identify NSCLC subjects who may benefit from AstraZeneca’s EGFR-tyrosine kinase inhibitor treatment, Tagrisso.
