The RealQuant® Lung Fusion Genes kit allows to detect by 45 molecular probes, in a single multiplex reaction, known and unknown fusion variants of ALK, ROS1 and RET starting from RNA extracted from fresh, frozen or paraffin tissue, or from cytological samples. In the same multiplex are included further 27 assays and related probes: 21 for reference genes necessary for data normalization and 6 for genes differentially expressed in normal and tumor lung tissue, useful for the evaluation of RNA quality and quantity and for neoplastic cell content.
In less than two days it is possible to move from the biological sample to standardized results and readily usable for the report, thanks to a dedicated software for NanoString® (RealQuant® Data Analysis Software) data analysis, that, among the other functions, performs the quality control and the evaluation of the analytical and pre-analytical steps.
The RealQuant® Lung Fusion Genes performances have been evaluated during a multicenter clinical study (LEONID1) in comparison with FISH, IHC and Real Time PCR. The concordance with the others methodologies was greater than 97%. The NanoString® technology, based on the hybridization of molecular probes (fluorescents barcode), allow the detection and quantification of a very high number of different target sequences (up to 800 in the same multiplex reaction), with only 4 pipetting steps and 15 minutes of “hand on-time”, reaching exceptional performances even on samples with low quantity and quality.
The innovative 3D Biology™ version of NanoString® technology also provides a multi-functional approach for the analysis of RNA, DNA (SNP, indel, CNV) and proteins in the same reaction tube.
The validation was performed in a clinical study in collaboration with the Surgical, Medical, Molecular and Critical Areas department, University of Pisa – Pisana (Pisa) University Hospital, and with the Level III Biosciences, Molecular Diagnostic laboratory – Biomarkers and personalized medicine, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS (Meldola).