In September last year, a box of nucleic acid detection kits that identify both the new crown and the flu was officially put into production and distributed in Shanghai.
As China's first approved pcroscope-based PCR platform COVID-19 influenza joint test product, it can quickly detect two diseases, targeted treatment, and has now covered hundreds of domestic medical institutions.
What is somewhat surprising is that the product developer Shanghai Sidia Biomedical Technology Co., Ltd. focused on accurate diagnosis of tumors before the outbreak of the new crown pneumonia epidemic. Although there is a layout in the field of infection, there is no product landing. After more than two years of development, its "cross-border" in the field of pathogen detection has achieved vigorous development from scratch to today.
How is this achieved?
R&D landing "accelerated"
Back in January 2020, the new crown pneumonia epidemic spread rapidly, how to quickly find scientific and effective testing and anti-epidemic "weapons" is not only needed by the country, but also expected by the people.
On January 26, members of the Research and Development Team of SidiDia Diagnostics, who rushed back to Shanghai from all over the country, received a message from the company: "Let every patient in the world get precision treatment at any time and any place." ”
At that time, the outbreak of the new crown pneumonia epidemic, the founder of the company, Xiong Lei, realized that he could use the technical reserves accumulated in the field of accurate diagnosis of tumors in the past to quickly carry out the research and development of nucleic acid detection products. "It seems to start from scratch, but we have accumulated for many years." So, on the spur of the moment, R&D personnel rushed to this new field.
During the Spring Festival, the core team of more than 40 people did not have a day off, from 8:00 a.m. to 10:00 p.m., completed the first generation of product research and development within a week, and sent a total of 7 employees to aid the severely affected areas in Hubei for three times, supporting nucleic acid testing to reach 4,000 cases per day, accounting for 25% of the testing volume in Wuhan in February. In November of the same year, one of the company's "new coronavirus nucleic acid detection kits" was officially included in the emergency use list by the World Health Organization.
"We can reach the target with sprint speed, which is inseparable from the strong support of the government." Chen Caifu, chief technology officer of Thought Di Diagnostics, told reporters that the relevant departments in Shanghai have opened a "green channel" for enterprises to resume work and production, and the Pujiang Hi-Tech Park of Lingang Group has given a preferential policy of rent reduction for 2 months during the epidemic period. Unreserved support and clean and rapid response allowed team members to return to Shanghai in time to put into production before the national epidemic prevention policy was tightened. At the same time, the Shanghai municipal government at all levels carries out "companion service", often concerned about asking about the difficulties and obstacles encountered by enterprises, and finding ways to help enterprises solve them.
For more than two years, In the process of promoting the upgrading and iteration of new crown pneumonia detection products, Weedy Diagnostics has also received help from regulatory authorities. Taking the first domestic covid-19 influenza joint inspection product developed by the team as an example, in the approval process, the Shanghai Municipal Food and Drug Administration guided how to fill in the materials and simplify the process, and gave priority review recommendations after a detailed understanding of the product performance, which greatly shortened the approval time and helped the product to come out as soon as possible.
"This detection product breaks through multiple difficulties such as multi-target accurate detection and high sensitivity, which can save time and economic costs, and also reduce stress for medical staff, and has now covered hundreds of medical institutions." Wu Yiming, a microbial researcher at Mind Di Diagnostics, introduced that in order to give more regions the opportunity to obtain medical services, companies are actively developing related complete sets of equipment according to the mobile application scenarios of new crown pneumonia detection. In August last year, Sidia Diagnostics provided P2+ mobile nucleic acid detection vehicles for the Kashgar region of Xinjiang to better meet the needs of rapid mobile detection in border areas.
Let precision medicine benefit universal benefits
As one of the early enterprises engaged in precision medicine in China, Sidi Diagnostics has experienced a period of "no one understands, no one supports, and no one interests" in the capital market.
The so-called precision medicine, in short, is to accurately detect the genes or other markers of normal people and individual cases, compare and analyze the disease situation, and accurately use targeted drugs, cell therapy and other therapeutic means to accurately combat the virus or gene, so as to safely and efficiently cure the disease.
More than a decade ago, the industry was blank. "It was all too common at the time for me to hand over a business plan to a well-known angel investor who picked it up at the venue and threw it on the ground." Xiong Lei recalled the ups and downs in the early days of entrepreneurship.
Nowadays, with the rising prevalence of cancer and other diseases in China and the gradual improvement of biomedical technology, precision medicine has become an important part of the national strategic emerging industry and a "new track" for Shanghai to actively exert efforts. Industry insiders pointed out that at present, precision medicine is in a state of "hot and cold coexisting". In the three major businesses of screening, diagnosis and drug development, any one of these individual areas may exert a long-tail effect and form a market of 100 billion. However, at present, the independent research and development of equipment and instruments, the production capacity is insufficient, and the use of technology needs to be further standardized.
"As the focus of the national biomedical industry, Shanghai has unique advantages in terms of talent resources, industrial chain and business environment, which provides an excellent stage for biomedical enterprises including ZhidiDia." The "14th Five-Year Plan for the Development of Advanced Manufacturing in Shanghai" proposes to accelerate the construction of a "3+6" new industrial system, including biomedicine. According to the statistics of the Municipal Commission of Economy and Information Technology, 18 of the top 20 pharmaceutical companies in the world and 17 of the top 20 medical devices have settled in Shanghai.
"In Shanghai, the highland of the biomedical industry, we are accelerating the layout, creating a whole industrial chain covering the upper, middle and lower reaches, and adhering to the development of precision diagnostic reagents, automated diagnostic equipment and intelligent analysis software." Chen Caifu said.
At present, some innovative research results of enterprises are at the forefront of related fields. For example, in the field of early diagnosis of tumors, an early auxiliary diagnosis product of ovarian cancer has completed clinical trials; in the research and development of fully automated equipment for molecular diagnosis, the fully enclosed automated library builder independently developed by the company has obtained a medical device registration certificate; in the field of medical digitalization and intelligence, the self-developed gene mutation analysis software, PD-L1 immunotherapy drug accompanying diagnosis artificial intelligence auxiliary diagnosis software, have obtained medical device registration certificates...
"The core of precision medicine is universal medicine, and after forming a complete upstream and downstream industrial chain, more people will enjoy more in-depth and accurate medical services." Xiong Lei talked about the vision of the industry, "I hope that in the future, China's county-level hospitals will have similar levels of medical diagnosis as large hospitals in Shanghai, because they use the same diagnostic products." ”