Anzhiyin Biotech's Zhou Yang: Cardiovascular Genetic Testing Emerges as the Next Blue Ocean in a Trillion-Yuan Diagnostic Market

For a long time, the tumor NGS sector has been highly competitive, with numerous companies entering the field. In certain products and niche markets, it has already entered a red ocean competition phase.

Compared with tumor NGS, genetic testing for cardiovascular diseases is a blue ocean market yet to be fully explored. The number of patients with cardiovascular diseases in China is huge, far exceeding that of tumors. According to the "Report on Cardiovascular Health and Diseases in China 2019,"The number of prevalent cardiovascular disease cases in China has reached 330 million, with its mortality rate ranking first among all causes of death in the country.far exceeding cancer and other diseases. As the "number one killer" of human health, cardiovascular disease has become a major public health issue in China.

The “Guidelines for Genetic Diagnosis of Monogenic Hereditary Cardiovascular Diseases” published in the Chinese Journal of Cardiology in March 2019 stated that,China has 40 million patients with monogenic hereditary cardiovascular diseases.Hereditary cardiovascular diseases are characterized by high incidence rates and a high probability of inheritance. Post-diagnosis interventions are well-defined. For instance, conditions such as hypertrophic cardiomyopathy and familial hypercholesterolemia follow an autosomal dominant inheritance pattern, with a transmission risk of 50%–70%.

Genetic testing for cardiovascular diseases has clear clinical significance and represents an essential need. It enables effective assessment of cardiovascular disease risk, facilitating early prevention, screening, and treatment, thereby reducing the incidence and mortality of cardiovascular diseases. This approach holds significant value in lowering healthcare costs and conserving medical insurance expenditures.

In recent years, many leading NGS companies have also begun to focus on and expand into the cardiovascular field.The cardiovascular disease genetic testing sector is rising strongly. At this juncture, ANNGEEN, with its comprehensive solutions and impressive commercial performance, is better positioned to lead in this field.

Zhou Yang, founder of ANNGEEN, was first exposed to molecular diagnostic products at ABI in his early years and personally witnessed the rapid iteration of gene testing technology.

In 2003, the Human Genome Project was completed, marking one of the greatest engineering feats in human history. “At that time, we hoped that the cost of whole-genome sequencing would drop from billions of dollars to under $1,000. The growth of genetic testing has far exceeded our expectations,” said Zhou Yang.

By 2014, the NGS sector had just experienced a surge in non-invasive prenatal testing (NIPT), while multiple NGS companies secured financing, driving a rapid rise in capital interest. “Starting from that year, NGS truly transitioned from the research market to clinical applications, allowing me to see the opportunity and sparking my idea to start a business.”

Surprisingly, in selecting a niche sector, Zhou Yang opted for what the general public considers a “niche” track—genetic testing for cardiovascular diseases.

Zhou Yang stated, “The potential of this sector is no less than that of oncology, yet it remains severely undervalued. Cardiovascular diseases pose serious health threats, with high incidence and mortality rates, and incur the highest treatment costs among all disease categories, imposing a heavy economic burden on society and patients’ families. The key to addressing the high incidence and mortality rates of cardiovascular diseases lies in accurate diagnosis, rational prescribing, and precise medication use.”Genetic testing can complement traditional diagnostic methods, such as scale-based assessments and imaging, to effectively identify disease risk and enable precision diagnosis and treatment, thereby reducing the number of cardiovascular disease patients in China.”

ANNGEEN is dedicated to applying NGS technology to provide comprehensive solutions in the field of precision medicine for cardiovascular diseases, thereby enabling precise diagnosis and treatment of these conditions. In 2016, the “Joint Training Center for Precision Medicine,” jointly established by the company, Fuwai Hospital of the Chinese Academy of Medical Sciences, and Thermo Fisher Scientific, was officially unveiled.First Publication of Mutation Frequencies and Their Significance in the General Population from China’s Largest Hereditary Cardiovascular Database; in 2018, the company successfully completed a Series A financing round of nearly RMB 100 million.

“After the completion of our Series A financing, we realized that although the LDT model holds a significant position in China, in the long run,”IVD integration is the mainstream of in-hospital testing and will rapidly supplant existing business models,Therefore, ANNGEENPioneering the Transition from Services to Products.” In 2019, ANNGEEN put its GMP-compliant manufacturing facility into operation and initiated its strategic layout for IVD products.

In 2020, ANNGEEN completed a Series B financing round exceeding RMB 100 million. Since then, the company has focused on precision diagnosis of cardiovascular diseases and medication testing, leveraging technological platforms such as NGS, immunoassay, POCT, and nucleic acid mass spectrometry to further strengthen its portfolio of IVD products.

Now,ANNGEEN has achieved full implementation of in vitro diagnostic (IVD) commercialization for cardiovascular genetic testing, with its IVD progress leading the industry.and has established long-term, in-depth collaborations with multiple leading Grade A tertiary hospitals and specialized cardiovascular hospitals.

In 2021, ANNGEEN joined forces with Professor Liu Lisheng and the Hypertension League to jointly establishChina Institute for Major Chronic Diseases,Implementing the clinical application of genetic testing and artificial intelligence technologies in hypertension, myocardial infarction, and stroke. During the same period,ANNGEEN initiated the establishment of the China FH 10,000-Person Screening Program,Established the Chinese FH genetic disease database, authored expert consensus on genetic diagnosis, and achieved the translational application of FH testing kits. In the same year, ANNGEEN, in collaboration with Peking University (the lead institution), Suzhou Municipal Hospital, Beijing Anzhen Hospital affiliated with Capital Medical University, Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, the First Affiliated Hospital of Xinjiang Medical University, and other institutions, jointly submitted an application forNational Key R&D Program of China’s 14th Five-Year Plan: Key Special Project on “Research on the Prevention and Treatment of Common and Frequently Occurring Diseases”"Research on New Targets for Screening and Intervention of Hypercholesterolemia in China" Project Approved for Establishment.

By forging deep collaborations with various centers and applying precise strategies, ANNGEEN is accelerating the standardization of clinical practices for precision diagnosis and treatment of cardiovascular diseases in China, promoting the translation of clinical medicine, and advancing precision diagnosis and treatment of diseases. This initiative aims to achieve early diagnosis and treatment, scientific prevention and control, and facilitate the transition from disease treatment to health management.

In the field of cardiovascular disease genetic testing, ANNGEEN has built diverse sequencing platforms and a powerful bioinformatics analysis platform. Notably, bioinformatics analysis and genetic interpretation are core components of cardiovascular disease genetic testing.

Zhou Yang stated,The challenge in genetic testing for cardiovascular diseases lies in the scarcity of professionals skilled in bioinformatics and genetic interpretation.“Unlike oncology, cardiovascular disease genetic testing lacks well-defined pathogenic hotspots and involves complex pathogenic variants.“A comprehensive assessment integrating genetic data, clinical manifestations, and family history is required, placing exceptionally high demands on professionals in bioinformatics and genetic interpretation.”

To address the shortage of talent in bioinformatics and genetic interpretation, ANNGEENAchieved full-process automation from data mining to digital interpretation, and independently developed a clinical-grade high-throughput sequencing data analysis platform.By integrating genotype-phenotype databases, we have developed data analysis systems tailored to different diseases and testing protocols, including CardioLyses, HematoLyse, GenoLyses, iAorta, and iBRCA. These systems enable flexible, accurate, and convenient analysis of genetic mutation information, thereby better supporting clinicians in interpreting patient results and guiding diagnosis and treatment.

ANNGEEN, leveraging resource advantages, data-driven insights, and technological supportA comprehensive solution has been established for a population of 40 million individuals with hereditary cardiovascular diseases., targeting conditions such as cardiomyopathies, arrhythmias, aortic disorders, and hyperlipidemia, it has launched multiple genetic testing products for hypertrophic cardiomyopathy, dilated cardiomyopathy, Marfan syndrome, and familial hypercholesterolemia.

“ANNGEEN’s launched and registered products have already covered 13 million of the 40 million individuals with hereditary cardiovascular diseases; the remaining population does not involve simple monogenic inheritance, and we are providing themProvides whole-exome sequencing solutions.Furthermore, to address the full-cycle medication needs of the 330 million cardiovascular disease patients in China, we provide therapeutic drug monitoring services. These services accurately assess each patient’s metabolic response to individual drugs, helping to determine optimal dosages, enhance therapeutic efficacy, reduce adverse reactions, and avoid “ineffective medical care.”

Zhou Yang believes: “The genetic testing industry has shown a trend of expanding from oncology to major chronic diseases such as cardiovascular diseases,"The market for genetic testing in cardiovascular diseases holds great promise and is poised to become the next blockbuster, following oncology."

The accelerated market launch of targeted cardiovascular drugs has further fueled the explosive growth of this sector. Amgen’s PCSK9 inhibitor, Repatha, was approved in China in 2018 for the treatment of homozygous familial hypercholesterolemia in adults and adolescents aged 12 years and older. In 2019, Repatha received additional approval for reducing the risk of cardiovascular events in adult patients with atherosclerotic cardiovascular disease. In 2021, Bristol-Myers Squibb (BMS) submitted a New Drug Application (NDA) for its innovative therapy targeting hypertrophic cardiomyopathy, aiming to support the treatment of patients with HCM.The number of gene therapy drugs for cardiovascular diseases is gradually increasing, and genetic testing for cardiovascular diseases will gain greater acceptance and recognition in the future.

Zhou Yang stated, “But overall,Cardiovascular disease genetic testing is in a period of rapid development,Enterprises need to possess stronger promotional capabilities and clinical implementation capabilities, particularly in primary care settings.“The vast majority of cardiovascular disease patients receive medical consultations and obtain prescriptions at primary care hospitals; therefore, it is crucial to rapidly extend the availability of genetic testing for cardiovascular diseases to these grassroots healthcare settings.”

“To drive the expansion of patient populations into grassroots markets, industry stakeholders must actively collaborate to promote the widespread clinical adoption of cardiovascular genetic testing, build industry consensus, and ensure that cardiovascular genetic testing products truly penetrate the primary care market.”ANNGEEN has established strategic partnerships with leading enterprises such as MGI Tech,Deepen and accelerate product development and translational applications, promote the widespread adoption of personalized diagnosis and treatment as well as genetic testing for cardiovascular diseases in China, and facilitate the advancement of precision cardiology.