EGFR T790M RealFast™ Assay
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EGFR T790M RealFast™ Assay - 1

EGFR T790M RealFast™ AssayA reliable tool to personalize therapy of lung cancer patients with acquired TKI-resistance mutation T790M in the EGFR gene Liquid profiling of NSCLC patients The EGFR T790M RealFast™ Assay detects the most common resistance mutation in plasma-derived, circulating cell-free DNA (cfDNA) from non-small-cell lung cancer (NSCLC) patients. As the epidermal growth factor receptor (EGFR) plays a crucial role in cell proliferation and growth, NSCLC patients with activating EGFR mutations in exons 18 and 21 may benefit from EGFR tyrosine kinase inhibitor (TKI) therapy. However, acquired resistance to these TKIs is frequent, with the T790M (c.2369C>T) mutation accounting for 50%-60% of the underlying mechanisms. Treatment with Osimertinib (Tagrisso®) has been established as an alternative therapy in patients who are positive for EGFR T790M. The ViennaLab Plasma cfDNA Extraction Kit is a column-based sample preparation kit allowing the extraction of high-purity cell-free DNA from up to 4 mL plasma. It has been developed and validated for use with the EGFR T790M RealFast™ Assay. ViennaLab EGFR T790M RealFast™ Assay r • For use with cell-free DNA samples obtained from plasma ^ • Highly sensitive (Limit of Detection: 8 mutant copies in 2.5 ng cfDNA) • Compatible with a wide range of real-time PCR instruments • Positive control included v • RealFast™ Assay for in vitro diagnostic useC€ 11 VP I y REF: • EGFR T790M RealFast™ Assay: 8-110/8-113 (100/32 reactions) • Plasma cfDNA Extraction Kit [RUO]: 2-040 (50 extractions) Manufacturer: ViennaLab Diagnostics GmbH Gaudenzdorfer Guertel 43-45 A-1120 Vienna, Austria www.viennalab.com

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