Introduction
The treatment of endometrial cancer has entered the era of molecular diagnostics, with treatment decisions and prognostic evaluations based on molecular classification criteria. Among the relevant biomarkers, alterations in p53 and MMR-related genes can be detected through immunohistochemical staining, while POLE gene mutation detection relies on next-generation sequencing technology. Due to the high cost and time-consuming nature of next-generation sequencing, it has not yet been widely adopted in clinical practice, resulting in most hospitals being unable to provide complete molecular classification testing for endometrial cancer patients. This invention has developed an innovative detection method utilizing quantitative polymerase chain reaction (qPCR) technology coupled with novel nucleic acid primer design to precisely detect mutation sites in the POLE gene exonuclease domain. The POLE exonuclease domain mutation detection kit developed based on this design achieves a mutation detection sensitivity as low as 1%. When compared and validated against next-generation sequencing results, the analysis showed high concordance across 11 pathogenic mutation sites. The advantages of this detection technology lie in its elimination of the need for additional synthesis of oligonucleotide blockers containing alternative nucleotides, as well as the requirement for expensive detection equipment. Therefore, it features low cost and rapid detection capabilities, enabling quick provision of clinically required test results with significant clinical application value and commercial potential.
Features / strengths
1.No need for additional synthesis of oligonucleotide blockers containing alternative nucleotides or nucleotide sequencing, resulting in low cost.
2.Uses equipment commonly available in molecular diagnostic laboratories, with no need for additional equipment purchases or personnel training.
3.Results are obtained quickly, with accuracy matching that of next-generation sequencing.
Specification in detail
Under development
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