For a long time, the tumor NGS track has been hot, there are many layout enterprises, and there has been a red sea competitive situation in some products and market segments.
Compared with tumor NGS, cardiovascular disease gene testing is a blue ocean market that has yet to be tapped. The number of cardiovascular disease patients in China is huge, far exceeding tumors. According to the "China Cardiovascular Health and Disease Report 2019", the number of patients with cardiovascular diseases in China has reached 330 million, and the mortality rate ranks first in the total mortality rate of diseases in China, far higher than other diseases such as tumors. As the "number one killer" of human health, cardiovascular disease has become a major public health problem in China.
In March 2019, the "Guidelines for the Genetic Diagnosis of Single-gene Hereditary Cardiovascular Diseases" released by the Chinese Journal of Cardiovascular Diseases pointed out that the number of single-gene hereditary cardiovascular disease patients in China reached 40 million. The incidence of hereditary cardiovascular disease is high, the genetic probability is high, and the intervention measures after diagnosis are clear, such as hypertrophic cardiomyopathy, familial hypercholesterolemia and other diseases are autosomal dominant, and the genetic probability is 50%-70%.
Cardiovascular disease genetic testing has a clear significance, is a rigid demand, through genetic testing can effectively judge the risk of cardiovascular disease, to achieve early prevention, screening and treatment of diseases, reduce cardiovascular disease incidence and mortality, to reduce medical costs, saving medical insurance costs have important value.
In recent years, many leading NGS companies have also begun to pay attention to and lay out the cardiovascular field. The cardiovascular disease genetic testing track is on the rise, and at this time, Azhiyin, which has a complete solution and a bright commercial performance, has more confidence on this track.
Take the lead in promoting IVD detection of cardiovascular diseases
Zhou Yang, the founder of AZ, was first exposed to molecular diagnostic products at ABI in the early years, and also witnessed the rapid iterative process of genetic testing technology.
In 2003, the Human Genome Project was completed, one of the greatest projects in human history. "At the time, we wanted the cost of sequencing the whole human genome to go from billions of dollars to less than $1,000. Genetic testing is growing much faster than we expected. Zhou Yang said.
Time to 2014, the NGS field has just experienced a wave of non-invasive prenatal testing boom, while a number of NGS companies completed financing, the rapid rise in capital heat. "Since the beginning of this year, NGS has really gone from the scientific research market to the clinic, allowing me to see opportunities and germinate entrepreneurial ideas."
Unexpectedly, in the choice of subdivision fields, Zhou Yang chose the "niche" track in the eyes of the public - cardiovascular disease genetic testing.
Zhou Yang said: "The potential of this track is no less than that of tumors, but it is seriously underestimated. Cardiovascular diseases are seriously harmful, morbidity and mortality are high, and the treatment costs rank first in the treatment costs of various diseases, which brings a heavy economic burden to society and patients' families. The key to solving the high incidence and mortality of cardiovascular disease lies in correct diagnosis, reasonable prescription, and accurate medication. Genetic testing technology can complement traditional methods such as scale diagnosis and imaging diagnosis, effectively identify the risk of disease, and achieve accurate diagnosis and treatment, so that there are fewer and fewer patients with cardiovascular diseases in China. ”
Az is committed to the application of NGS technology to provide overall solutions in the field of cardiovascular precision medicine to achieve accurate diagnosis and treatment of cardiovascular diseases. In 2016, the "Precision Medicine Joint Training Center" jointly established by the company and Fuwai Hospital of the Chinese Academy of Medical Sciences and Thermo Fisher Scientific was officially listed, announcing for the first time the frequency and significance of mutations in the largest hereditary cardiovascular database in China in the population; in 2018, the company successfully completed nearly 100 million yuan of A round of financing.
"After the completion of the A round of financing, we realized that although the LLT model occupies an important position in China, in the long run, IVD is the mainstream of in-hospital testing and will quickly cover the existing business model, so AZ took the lead in starting the transformation from service to product." In 2019, Azien GMP plant was put into use and started the IVD product layout.
In 2020, Azilla completed more than 100 million yuan of B round financing. Since then, the company has focused on the accurate diagnosis of cardiovascular diseases and drug detection business, relying on NGS, immunity, POCT, nucleic acid mass spectrometry and other technical platforms to further deepen the layout of IVD products.
At present, Ahn Has achieved the full landing of IVD in cardiovascular disease genetic testing, and the progress of IVD is leading the industry, and has reached long-term in-depth cooperation with a number of top three and cardiovascular specialist hospitals.
Just in 2021, An Zhiyin, together with Professor Liu Lisheng and the Hypertension Alliance, jointly built the China Major Chronic Disease Research Institute to carry out genetic testing and artificial intelligence technology in the clinical application of hypertension, myocardial infarction and stroke. During the same period, Ahn Chi initiated the establishment of China's FH 10,000 people screening program, established a Chinese FH genetic disease database, wrote an expert consensus on genetic diagnosis, and realized the transformation of FH detection kits.
In the same year, Anzhi was approved for the national "14th Five-Year Plan" National Key Research and Development Plan "Research on Common Multiple Diseases Prevention and Treatment" Key Special Project "Research on Screening and Intervention of Hypercholesterolemia in China" jointly submitted by Peking University (the lead unit), Suzhou Municipal Hospital, Beijing Anzhen Hospital affiliated to Capital Medical University, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, and the First Affiliated Hospital of Xinjiang Medical University.
Through in-depth cooperation with various centers, Anzhiyin has accelerated the standardized clinical practice of accurate diagnosis and treatment of cardiovascular diseases in China and the transformation of clinical medicine and the accurate diagnosis and treatment of diseases in China, so as to realize the early diagnosis and treatment of diseases, scientific prevention and treatment, and transform disease treatment to health management.
The solution covers 40 million
People with hereditary cardiovascular disease
In the cardiovascular disease genetic testing track, Ahn Has built a diversified sequencing platform and a powerful life information analysis platform. It is worth noting that the analysis of birth letters and genetic interpretation are the core links of cardiovascular disease genetic testing.
Zhou Yang said that the difficulty of genetic testing for cardiovascular diseases lies in the lack of biological information and genetic interpretation talents. "Cardiovascular disease gene detection is different from tumors, there is no clear pathogenic hotspot, and there are complex pathogenic variants, which require comprehensive judgment based on information such as genes and clinical manifestations and family history, and the requirements for biological information and genetic interpretation are extremely high."
In order to make up for the lack of biological information and genetic interpretation talents, Anzhi has realized the automation of the whole process from data mining to digital interpretation, independently developed a clinical application high-throughput sequencing data analysis platform, combined with the genotype-phenotype database, and developed data analysis systems including CardioLyses, HematoLyse, GenoLyses, iAorta, iBRCA and other data analysis systems for different diseases and different detection schemes, which can flexibly, accurately and conveniently analyze genetic mutation information , to better support clinicians in interpreting and treating patient outcomes.
Combining resource advantages, data-driven and technical support, Ahn Has formed a complete solution covering 40 million people with hereditary cardiovascular diseases, and has launched a number of genetic testing products such as hypertrophic cardiomyopathy, dilated cardiomyopathy, Marfan syndrome, familial hypercholesterolemia and other diseases for cardiomyopathy, arrhythmia rate, aortics, hyperlipidemia and other diseases.
"AZ's products that started registration have covered 13 million of the 40 million people with hereditary cardiovascular diseases, and the remaining population is not simply single-gene inheritance, we provide them with a full exon detection solution." In addition, in response to the full-cycle drug demand of 330 million people with cardiovascular diseases, we provide medication testing services to accurately judge the metabolism of each drug in patients, help patients determine the dosage, improve efficacy, reduce adverse reactions, and avoid 'ineffective medical treatment'. ”
The main battlefield of genetic testing is being taken from
Tumors expand into major chronic disease areas such as cardiovascular diseases
Zhou Yang believes: "The genetic testing industry has shown a trend of expansion from tumors to major chronic diseases such as cardiovascular diseases, and the cardiovascular disease genetic testing market is promising and is expected to become another hit after tumors." ”
Accelerating the launch of cardiovascular disease targeted drugs has accelerated the outbreak of this market. Rebbett, a PCSK9 inhibitor developed by Amgen, was approved in China in 2018 for the treatment of homozygous familial hypercholesterolemia in adults or adolescents over 12 years of age, and in 2019, Rebbett was approved for adult patients with atherosclerotic cardiovascular disease to reduce the risk of cardiovascular events. In 2021, Bristol-Myers Squibb (BMS) innovative drug for hypertrophic cardiomyopathy was submitted to the NDA to support the treatment of HCM patients. The number of cardiovascular disease gene therapy drugs is gradually increasing, and cardiovascular disease gene testing will be more and more accepted and recognized in the future.
Zhou Yang said: "But in general, cardiovascular disease genetic testing is in a period of rapid development, which requires enterprises to have stronger promotion capabilities and clinical landing capabilities, especially at the grass-roots level. "The vast majority of cardiovascular disease patients' medical treatment and medication treatment occur in grass-roots hospitals, so it is crucial to promote the rapid sinking of cardiovascular disease gene testing."
"If you want to achieve the sinking of the patient population, you need the active cooperation of relevant companies in the industry to form an industry consensus by promoting the wide application of cardiovascular disease gene testing in the clinic, so that cardiovascular disease genetic testing products can truly enter the grass-roots market." Azien has reached strategic cooperation with BGI Intelligent Manufacturing and other leading enterprises to deepen and accelerate product development and application transformation, promote the widespread popularization of individualized diagnosis and treatment of cardiovascular diseases and genetic testing in China, and help the development of cardiovascular precision medicine.