Zhu Yeqing: The total market value of China IVD listed companies is CNY 540 billion, and the cancer early screening industry cannot have only one registration certificate

Recently, during the first ZAODX World Cancer Early Screening Conference, Zhu Yeqing, CEO of New Horizon Health Ltd, said that according to CAIVD statistics, there are 58 listed enterprises with IVD business in China by the end of 2021, with a total revenue of 145.032 billion CNY, and the total market value of listed enterprises with IVD business in China as of June 30, 2022 is 547.644 billion CNY. The industry average PS is about 4, and the PE peak in 2021 is about 60, which is normally close to 45.

Covid-19 detection and early screening for cancer have become new tracks for traditional IVD companies to break the game. The COVID-19 epidemic has greatly promoted the process of cross-border consumption of cancer early screening, accelerated the transition from hospitals to home scenarios, and the target population has also shifted from hospital patients to asymptomatic high-risk "healthy people".

In the keynote report, Zhu Yeqing believes that the cancer early screening industry cannot take advantage of the sudden outbreak of opportunity like nucleic acid testing. The barriers to early cancer screening are scientifically based and clinically verifiable. Clinical data is the ultimate criterion for testing all products. He made it clear that the realization of cancer early screening should use a multi-omics platform, and it is difficult to achieve cancer screening with a simple technology and a target, especially related precancerous lesions, and the negative predictive value (anti-leakage detection ability) is the core index for evaluating cancer early screening products.

On March 5, 2021, the official public account of the State Food and Drug Administration, "China Instrument Review", issued a document clearly stating that "the previously approved related products (products approved for auxiliary diagnosis) have not been prospectively clinically tested in accordance with the requirements, and it is impossible to systematically evaluate the positive and negative predictive values of the products." “

According to the public information on the official website of the State Food and Drug Administration, at present, only Chang Weiqing has an IVD class III medical device cancer early screening license approved in China, which is clearly "suitable for screening people with high risk of colorectal cancer at the age of 40-74" in the intended use.

Zhu Yeqing believes that there is still a misunderstanding about the cognition of cancer early screening products. The clinical value of early cancer screening focuses not on finding more cancer patients, but on patients with precancerous lesions earlier. Early cancer screening must have: clear clinical guidance, simple diagnosis methods and feasible clinical interventions. If a patient who tests positive is not intervened or terminated, screening methods often bring more anxiety and pain to the patient, and lose the health economic value of screening.