Agena Bioscience, a San Diego-based clinical diagnostics and life sciences company, recently announced the release of a new assay called LungFUSION Panel that can efficiently identify specific oncogenic gene fusions (ALK, RET, and ROS1) in non-small cell lung cancer (NSCLC).

The LungFUSION Panel uses only 10 ng of cDNA and is able to identify clinically relevant expressed translocations in formalin-fixed paraffin-embedded (FFPE) and also in new frozen samples of lung tissue. The MassARRAY-based test is a highly sensitive, quantitative method for nucleic acid detection, providing an alternative to the traditional methods including FISH and IHC stains, as both these methods need time-consuming procedures and also high quality tissue samples.

Last February, a team of researchers from the Wayne State University School of Medicine published a similar panel for NSCLC  in the Journal of Thoracic Oncology. The researchers evaluated RET and ROSI translocations using their own MassARRAY-based method, which had a different assay design than Agena Bioscience’s innovative panel, and was able to “detect an event in test specimens containing 0.5% positive tumors” and has an “exceptionally low sample input, high cost efficiency, flexibility, and rapid turnover.”

“Rare events in NSCLC tumor samples can be difficult or laborious to determine through optical genetic analysis techniques. The LungFUSION panel is an inexpensive, single-well assay amenable to formalin-fixed tissue and fine needle aspirates which may be of varying quality, allowing NSCLC studies to expand in sample size and confidence level within existing research budgets,” said Marisa Pearce, Agena Bioscience’s Sr. Director of Marketing in a press release.

Thanks to built-in controls, the new panel is able to examine RNA quality, to identify DNA contamination and also to evaluate the quantity of lung tissue in the sample. This technology then reports the translocation status for each of the tissue samples while determining an overall confidence score.

The MassARRAY platform is able to directly detect genetic variations using an end-point PCR and also mass spectrometry. Due to the accurate level that mass spectrometry offers, the data derived from the platform can be used to confirm genome sequencing variants. The flexibility of the technology and its simple bioinformatics allow laboratories to develop specific panels for specialized or routine tests for a much affordable price.

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