Rapid CE-Marked IVD Lung Cancer Test Delivers Results Within Three Hours

Lung cancer remains the leading cause of cancer deaths, with non-small cell lung cancer (NSCLC) being the most common type of lung cancer. Gene fusions represent an important class of gene rearrangements and have become important in NSCLC, as they are linked to responses to certain targeted therapies. Their accurate and fast detection is critical to guide therapy choices, which is the reason why testing for gene rearrangements such as gene fusions is included in international NSCLC testing guidelines. However, comprehensive testing of actionable gene rearrangements in NSCLC is often complex and can require different technologies. In order to test all needed biomarkers, laboratories usually have to use different instruments which are often not available within their own lab. Using different instruments also requires having enough biopsy samples of sufficient good quality, which can be difficult to obtain, especially in NSCLC patients. Now, a rapid CE-marked IVD lung cancer testing solution for laboratories provides comprehensive testing results within 180 minutes, significantly faster than currently available testing methods which often take days or even weeks before results are available.

The fully automated Idylla GeneFusion Panel (CE-IVD) from Biocartis Group NV (Mechelen, Belgium) detects in one single cartridge ALK, ROS1, RET and METex14 skipping, a wide range of actionable targets relevant in NSCLC. Designed for use in clinical laboratories, the panel consolidates traditional testing workflows into one streamlined, fully-automated process. One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. However, the panel only requires a limited amount of sample, thereby saving valuable tissue specimens.

The Idylla GeneFusion Panel detects ALK, ROS1 and RET fusions & MET exon 14 skipping in a single cartridge using only 1-3 FFPE tissue sections from patients with NSCLC. By offering results in a minimum amount of time, the panel shortens the time from sample to treatment initiation to one or two days. The panel demonstrated high concordance results in a clinical comparison study where ALK was compared with IHC, and ROS1, RET and METex14 skipping were compared with NGS.

“Turnaround time and time-to-treatment remains an important barrier to molecular testing. It has been demonstrated that 10% to 20% of advanced lung cancer patients do not receive the appropriate targeted therapy because biomarker results are not provided in a timely fashion,” said Herman Verrelst, Chief Executive Officer of Biocartis.

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