
A gene testing company focused on the research and development of tumor liquid biopsy technology has made a breakthrough in the development of "multi cancer early screening technology based on circulating tumor DNA (ctDNA)", but faces problems such as scattered patent layout and insufficient academic authority. This technology combines targeted capture with high-throughput sequencing to achieve early detection of 8 common cancers, with a sensitivity of 92% and specificity of 98%. However, the research and development team has only applied for 4 invention patents and has not formed systematic protection. The core methylation site screening method and sequencing data analysis algorithm are facing the risk of being borrowed; Simultaneously published papers have small sample sizes and insufficient data support, making it difficult to gain industry recognition.
We went deep into the R&D center and laboratory of the enterprise, conducted technical exploration, and identified 12 core innovative points, including ctDNA enrichment methods, methylation marker screening, and multidimensional data analysis models. In response to the issue of patent layout, a full chain patent strategy of "core markers+detection methods+data analysis" has been formulated to assist enterprises in completing 25 patent applications, including 18 invention patents forming a tight protection network, especially the patent of "a methylation marker combination for early screening of multiple cancers and its application", covering key detection targets and building core technological barriers.
In terms of improving academic papers, I guided the R&D team to expand the clinical sample size, collaborated with multiple hospitals to conduct multicenter research, and wrote 6 academic papers on topics such as "Clinical Validation of Early Screening Technology" and "Comparison of Detection Efficacy for Different Cancer Types". By standardizing experimental design and data presentation, the clinical application value of the technology is highlighted, with 4 papers included in the Chinese Journal of Oncology and 2 papers published in Clinical Oncology Research (Impact Factor 10.1). The papers cite authorized patents of the enterprise as the technical basis, enhancing the credibility and innovation of the research.
After one year of project implementation, the company's patent portfolio coverage reached 95%, successfully responding to one patent infringement dispute and safeguarding market rights. Academic papers have been cited 320 times, and companies have been invited to participate in the development of industry standards for tumor liquid biopsy technology. The technology has obtained a Class III medical device registration certificate from the National Medical Products Administration, and has established exclusive cooperation with 20 medical examination institutions. The annual inspection and measurement have exceeded 100000 people, and the annual sales revenue has exceeded 250 million yuan, becoming a technology leader in the field of early screening for tumors.