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Biocartis Nabs CE Mark for Lung Cancer Test

NEW YORK – Belgian diagnostic firm Biocartis announced on Monday that its Idylla GeneFusion Panel for lung cancer has received CE-IVD marking. 

The test simultaneously detects ALK, ROS1, RET, and MET exon 14 skipping, actionable targets relevant in non-small cell lung cancer, in three hours. The automated panel is designed for use in clinical labs and can be used to guide therapy choices, the company said in a statement. 

The test also requires a limited amount of sample, "thereby saving valuable tissue specimens," the firm said. 

In 2020, Biocartis received a €1.2 million ($1.3 million) grant from Belgium's Agency for Innovation and Entrepreneurship to develop the test, and it launched the panel as a research-use-only assay in 2021. 

"Turnaround time and time to treatment remains an important barrier to molecular testing," Biocartis CEO Herman Verrelst said in a statement. "It has been demonstrated that 10 percent to 20 percent of advanced lung cancer patients do not receive the appropriate targeted therapy because biomarker results are not provided in a timely fashion." With the new Biocartis panel, "laboratories will have a rapid, actionable, and in-house solution at their disposal which can be seamlessly integrated into virtually any laboratory workflow."