EML4-ALK Fusion Detection Using Specific Primers and Probes
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Solution Overview
Problem
Current methods lack effective detection and therapeutic strategies for cancers involving the EML4-ALK fusion gene, which is present in approximately 5-10% of lung cancer patients and contributes to tumorigenicity through kinase activity.
Innovation Solution
Isolation and detection of the EML4-ALK fusion polynucleotide and polypeptide, along with the development of a method for screening inhibitors, enabling the identification of therapeutic agents that target this oncogene in cancer cells.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current detection methods are used, then general cancer detection is possible, but detection of EML4-ALK fusion gene specifically is not achieved
Solution Approach 1:
The patent introduces specific primers and probes as intermediary tools that specifically recognize and bind to the EML4-ALK fusion gene sequence. These intermediaries enable selective detection of the fusion gene among other genetic material in the sample, resolving the contradiction between general detection capability and specific detection precision.
Solution Approach 2:
The detection method employs primers and probes with locally optimized sequences that specifically target the fusion region between EML4 and ALK genes. This local specificity allows the system to distinguish the fusion gene from normal gene sequences, achieving high measurement precision for this specific target while maintaining ease of operation through standardized PCR procedures.
2Reliability
If conventional cancer treatment approaches are used, then general treatment is provided, but targeted therapy for EML4-ALK positive cancers is not achieved
Solution Approach 1:
The patent implements preliminary detection of EML4-ALK fusion gene status before initiating treatment. This preliminary action allows clinicians to identify patients who will benefit from ALK inhibitor therapy, enabling tailored treatment approaches that improve reliability of treatment outcomes while avoiding unnecessary complexity for patients who do not harbor the fusion gene.
3Productivity
If no specific detection method is developed, then research progress is limited, but development of specific detection and screening methods enables identification of therapeutic targets
Solution Approach 1:
The patent segments the detection process into distinct components: specific primers for amplification, probes for detection, and standardized screening protocols. This segmentation enables the method to be easily manufactured and implemented in clinical settings, improving research productivity by providing a reliable tool for identifying EML4-ALK positive cases while maintaining ease of manufacture through modular design.
Data Source
AI summary
The present inventors found that a fusion gene present in some cancer patients is an oncogene. The present invention relates to a polypeptide as a novel fusion protein, a polynucleotide encoding the polypeptide, a vector comprising the polynucleotide, a transformed cell comprising the vector, a method for detecting the fusion protein or polynucleotide, a method for screening a therapeutic agent for cancer, and a method for treating cancer that is shown to be positive for the fusion gene. Further, the present invention relates kit, primer set, and probe useful in the detection of cancer that is shown to be positive for the fusion gene.