Another innovative technology companion diagnostic kit was approved, and Yan Linghua, founder of Tongshu Gene, talked about the future development direction of tumor molecular diagnosis
Recently, the full-site osimertinib diagnostic kit "Human EGFR Gene Mutation Detection Kit (Fluorescent PCR Method)" (trade name: Jianyiqing) independently developed by Tongshu Gene, a leading genetic diagnosis company in China, was successfully launched and obtained the registration certificate of Class III medical devices (National Machinery Approval 20243400588) of the State Drug Administration, filling the gap in the field of companion diagnostics in China.
The kit covers multiple key sites of EGFR gene mutations, including 19Del, L858R and T790M, and is currently the only accurate solution in China that provides comprehensive site coverage for the companion diagnosis of osimertinib.
We invited Yan Linghua, the founder of Tongshu Gene, to talk about this kit and the future development direction of tumor molecular diagnosis.
Mr. Yan, we have learned that Tongshu Gene has been approved for an EGFR companion diagnostic kit with independent innovation technology, congratulations, can you introduce it to us?
Yan Linghua: Thank you. After 6 years of research and development, Tongshu Gene's "MASS-PCR method" is the only type III detection kit in China that has been approved for 19Del, L8585R, and T790M for osimertinib companion diagnosis (all non-small cell lung cancer), marking another innovative breakthrough in Tongshu Gene's self-developed gene diagnosis platform technology!
PS: At present, there are 26 kits approved by the State Food and Drug Administration to detect EGFR mutations using PCR technology, but only 5 kits can be used as companion diagnostics!
We all know that there are many EGFR kits for the PCR platform that have been approved.
Yan Linghua: The launch of the "Diagnostic Easy to Clear" EGFR kit not only marks a breakthrough in the first domestic original innovative PCR technology diagnostic kit (most of the previously approved kits are ARMS-PCR). Moreover, in the following two application scenarios, it is of great significance to improve the compliance, accuracy and economy of genetic diagnosis of non-small cell lung cancer patients:
1. Genetic diagnosis of non-osimertinib resistance and re-biopsy in patients with advanced EGFR mutations (Tongshu Gene is the only tissue approved T70M osimertinib companion diagnosis)
2. After surgery for early-stage non-small cell lung cancer, there is an opportunity to use osimertinib as an adjuvant treatment for the genetic diagnosis of patients (providing the benefit of full-site osimertinib companion diagnosis)
Molecular diagnosis of oncology has always been a hot topic in the biopharmaceutical market, but it has been controversial recently, how do you see the future development direction of this industry?
Yan Linghua: This is a very good question, we all know that after nearly 20 years of development of anti-tumor therapy, most cancers have entered the era of precision diagnosis and treatment. Precision diagnosis and treatment of tumors can not only extend the survival time of patients with advanced tumors to more than 5 years, but also significantly improve the quality of life of patients and return to normal social life, so it also has high social value.
However, the first step of precision anti-tumor therapy is accurate diagnosis, and the most important part of accurate diagnosis is molecular typing diagnosis. Therefore, the accuracy, cost-effectiveness, and compliance of molecular diagnostics are very important.
As for the future of tumor molecular diagnostics, I have expressed countless times that this industry is still in the early stage of development, far from reaching the plateau period of this industry, and even the accelerated rise period may not have yet arrived. Why do you say that? I think there are three main points:
First, the aging of the population leads to an increase in the incidence of cancer: the elderly population has become a high-risk group for cancer due to the decline of physical function, weakened immunity, and long-term exposure to various environmental and lifestyle risk factors. In addition, with the advancement of medical technology and the improvement of people's living standards, people's life expectancy continues to increase, which also provides more time windows for the occurrence of tumors. Therefore, in response to the challenges brought about by the aging population, we must attach great importance to the prevention and treatment of cancer.
Second, the state attaches great importance to and supports precision anti-tumor drugs. According to the Guidelines for the Clinical Application of Novel Anti-tumor Drugs (2023 Edition) issued by the National Health Commission, 62 precision anti-tumor drugs have been approved in China, involving 18 cancers. Most of these drugs have been approved for marketing or included in medical insurance, and there are about 16 genes that require molecular diagnosis. Of these 16 genes, there are only about 5 genes that have been approved for companion diagnostics so far. So you see, there are still about 10 genes with companion diagnostics that have not yet been approved, and these are unmet market needs.
Third, the molecular diagnosis of tumors is developing profoundly from advanced companion diagnosis to early screening of early tumors and even high-risk groups of tumors. In the past, molecular diagnosis of tumors mainly focused on companion diagnostics in patients with advanced disease, providing guidance for targeted drug use, thereby reducing the risk of drug use and improving treatment efficiency. However, this diagnostic approach is often inadequate for the detection and treatment of early-stage tumors.
With the rapid development of molecular biology, genomics and other technologies, the accuracy and efficiency of tumor molecular diagnosis have been significantly improved. This allows us to carry out accurate screening and diagnosis in the early stages of tumorigenesis, even in high-risk groups. By detecting biomolecules associated with tumorigenesis, we can predict the risk of tumor occurrence and achieve early intervention and treatment, thereby significantly improving the survival rate and quality of life of patients.
Tongshu Gene is currently a leading tumor molecular diagnosis company in China, can you introduce us to the future product layout of Tongshu Gene?
Yan Linghua: Okay. We all know that domestic molecular diagnostics is a strong regulatory and compliance environment, so it is crucial for any good technology to truly benefit patients and obtain national access approval.
Tongshu Gene has always hoped to find a combination point in the three aspects of "good technology, good products, and unmet strong market demand", which will be used as the basis for the future product layout of Tongshu Gene.
First of all, with the continuous advancement of technology, tumor molecular diagnostic products will pay more attention to precision. By digging deep into genomics, transcriptomics, proteomics and other multi-omics data, we can more accurately identify tumor-related biomarkers, and provide a more accurate basis for early diagnosis, typing, prognosis assessment and treatment selection of tumors.
Secondly, high efficiency is also an important development direction for tumor molecular diagnostic products in the future. By optimizing the diagnostic process, increasing the speed of testing, and reducing the cost of testing, we can enable more patients to benefit from molecular diagnostic technology and realize rapid screening and early diagnosis of tumors.
In terms of specific product layout, Tongshu Gene will continue to expand around MSI and ctDNA (liquid biopsy) technology in the future, improve the technical moat (MSI detection from first-generation sequencing to NGS), improve detection accuracy (develop more detection products in MRD and early screening), popularize detection accessibility, and submit more products for intended use to better meet clinical needs, with the ultimate goal of improving the survival rate and quality of life of cancer patients.