The spring of IVD self testing is coming!

Mondo Social Updated on 2024-01-29

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For a period of time at the end of 2022, I would receive dozens of ** inquiries every day, asking if there was a way to buy a new crown antigen kit. This kit can be used to determine if an infection is present, which in turn can help the patient take the next step**. At that time, I had hundreds of antigen reagents sent by various IVD manufacturers on hand, and I gave them to my friends.

This is the first time that the IVD test kit has entered the homes of ordinary people on a large scale.

Prior to this, the widely recognized home self-test products were mainly blood glucose tests and early pregnancy tests.

China's public demand for these two types of products has created a testing market of nearly 4 billion yuan and nearly 1 billion yuan respectively every year.

In addition, due to the need for convenience and privacy, the demand for home self-testing such as HIV, Helicobacter pylori, HPV and other infectious diseases and early tumor screening has been further released, and self-testing products have also begun to be available.

With the high incidence of respiratory diseases in autumn and winter, antigens and antibodies used for influenza, mycoplasma and other detections, and nucleic acid testing for home sampling are also opening the door to self-testing. Looking at the popularity of JD.com and Meituan's orders, the public is obviously willing to accept such services.

Easy to buy, easy to operate, fast screening**, reduce hospital queues, so that more and more people are willing to pay for self-testing.

The spring of IVD self-testing is coming.

The home is expected to be the second most important disease detection and prevention scenario in the future after hospitals.

Among the many home testing projects, the market for early screening and early detection of tumors is ushering in rapid development.

In the past three years, many excellent companies and abundant testing products have emerged in the field of early tumor screening and early detection.

As the country with the largest number of new cancer cases and deaths, China has an increasing medical burden of malignant tumors.

The value of early screening and early detection has been recognized and has been included in various cancer diagnosis and treatment guidelines.

Early diagnosis and early ** make the survival rate of patients higher.

Early cancer screening is a health behavior with high certainty, low investment and great benefits.

Among the many early screening and early detection companies, many of them first focus on bowel cancer.

Colorectal cancer has the characteristics of high morbidity and mortality, long time (10-15 years) required for malignant transformation, early symptoms are not obvious, screening is easy to find, and the early 5-year survival rate is high, which is one of the most suitable cancers for early screening.

Wang Xishan, chairman of the colorectal cancer committee of the Chinese Anti-Cancer Association and director of the colorectal surgery department of the Cancer Hospital of the Chinese Academy of Medical Sciences, believes that the most important way to prevent cancer is to find "symptoms" in early screening and nip the signs of cancer in the bud before it worsens.

According to the Chinese Guidelines for Colorectal Cancer Screening, Early Diagnosis and Early Treatment and the Chinese Technical Guidelines for Integrated Diagnosis and Treatment of Tumors - Liquid Biopsy, there are currently a variety of methods that can be used for colorectal cancer screening, mainly including colonoscopy, immunoassay fecal occult blood detection (FIT), blood SEPTIN9 gene methylation detection, colon CT imaging technology, multi-target fecal FIT-DNA detection, etc.

Among the most recommended screening techniques, only FIT and colonoscopy are recommended.

Colonoscopy is the gold standard for colorectal cancer screening, with a detection rate of more than 90% for polyps and cancers, allowing for simultaneous diagnosis and **.

However, colonoscopy is an invasive test and is recommended every 5-10 years. Moreover, China's colonoscopy resources are tight, there are less than 30,000 digestive endoscopy doctors in the country, and less than 30 million cases of colonoscopy can be completed a year. The "Guidelines for Colorectal Cancer Screening, Early Diagnosis and Early Treatment in China" recommends regular colorectal cancer screening for the general population aged 40-74, and it is calculated that 600 million people in China need to be screened every year. Colonoscopy resources are so tight, and colonoscopy alone for colorectal cancer screening cannot be met at all, and FIT, DNA and other means are needed to supplement the screening.

The main technical principle of FIT is to detect human hemoglobin in stool specimens through specific antibodies, and then indicate possible intestinal lesions, which is more sensitive and specific than chemical detection, and is not affected by diet and animal hemoglobin. Patients with positive FIT are recommended to follow the doctor's instructions and carry out clinical examinations such as blood septin9 gene methylation test and colonoscopy as soon as possible to further rule out the risk of bowel cancer.

FIT is easy to use, low cost, and can be used as an effective supplement to high-precision testing, and current domestic and foreign guidelines recommend FIT screening once a year.

On the whole, FIT is one of the most suitable early screening methods for bowel cancer for home application.

Tracing back to the first domestic colon cancer approved by the NMPA, early screening and early detection products, I have to mention Boer Cheng.

Founded in 2006, Bolcheng's colorectal cancer early detection product Septin9 gene methylation detection kit was approved by the National Medical Products Administration (NMPA) in 2015, and this product is also the first registered product for liquid biopsy and gene methylation in China, which was evaluated by experts as "the first in China and has significant clinical application value". At the same time, the SEPTIN9 gene methylation test has been included in the colorectal cancer screening guidelines in China and the United States, and it is also the only colorectal cancer early blood detection program that has obtained CE, FDA, NMPA certification at the same time.

While deeply cultivating innovative detection technologies such as gene methylation, Bor Cheng is also continuing to develop projects that can be used for public self-testing, such as FIT, and is committed to further moving the threshold of early cancer detection.

Recently, Beijing Hyundai Gundam, a wholly-owned subsidiary of Bor Cheng, has launched a new test kit for the detection of occult blood (colloidal gold immunochromatography) independently developed by Beijing Hyundai Gundam.

This product is suitable for fecal occult blood testing by medical professionals in medical units, and can also be used by non-professionals outside medical institutions. This means that Good Morning can be widely used in early screening for digestive tract diseases and bowel cancer, and consumers can self-test their intestinal health at home.

This also means:

Nearly 600 million people in China who are screened for bowel cancer can buy this FIT reagent through the Internet and pharmacies, and complete the test at home to understand the health risks of digestive tract diseases and bowel cancer in a timely manner.

This test is quite simple, similar to the antigen test reagent during the new crown period, except that the sample used for the new crown test is a nasopharyngeal swab, and the fit uses a small number of stool samples.

After sampling, you can get positive and negative results 5 minutes, which is much simpler than going to the hospital** to queue up and order a colonoscopy.

Of course, this test is not a substitute for colonoscopy, if the FIT results are positive, it is recommended to go to the hospital to follow the doctor's instructions for blood septin9 gene methylation test, colonoscopy and other further examinations.

On November 14, 2023, the National Health Commission issued a notice on the "Healthy China Action - Implementation Plan for Cancer Prevention and Control Action (2023-2030)".

The notice clearly stated that it is necessary to promote early diagnosis and early treatment of cancer, strengthen the long-term mechanism of screening, and improve and promote the guidelines for early diagnosis and early treatment of key cancers. For key cancers such as gastric cancer, esophageal cancer, colorectal cancer, cervical cancer, breast cancer, and lung cancer, which have a high incidence rate and relatively mature screening methods and technical solutions, organize and improve a series of technical guidelines for screening, early diagnosis and early treatment, and promote and apply them nationwide.

Early cancer screening has ushered in policy encouragement and support.

The earlier the tumor is detected, the higher the rate. With the innovation of the first method, surgery, radiotherapy and chemotherapy, targeting, biological cells, etc. have also made great progress in solving the problem of cancer, and the "terminal disease" in the public perception is becoming a chronic disease.

We believe that in the future early screening market, the combination of self-testing and medical professional institutions will become more and more common.

Home self-testing requires low-cost, highly accessible, and easy-to-operate tests to screen out high-risk groups and further enter professional institutions for diagnosis and**.

During the epidemic, people's Xi of home testing has been cultivated, and with the rise of public health awareness, the health testing products on e-commerce platforms are showing a trend of volume, and the cancer home testing market will eventually usher in rapid development.

According to relevant research reports, the domestic early cancer screening market will grow from US$18.4 billion in 2019 to US$28.9 billion in 2030. By 2025, the market size is expected to exceed 23.6 billion US dollars (about 150 billion yuan).

In 2022, Wang Jianming, chairman of Borcheng, said in an interview, "Our ideal is to keep more people away from cancer and major diseases, and strive to reduce China's cancer mortality rate (compared with now) by 50% in the next 20 years. ”

This is a long-term goal, but it is not an impossible task.

As a pioneer and pioneer in the field of early detection, early diagnosis and early intervention of major diseases, Borcheng is deeply engaged in the field of early detection, early diagnosis and early intervention of major diseases such as cancer and cardiovascular and cerebrovascular diseases. The four core industrialization platforms of medical equipment have been approved by the State Drug Administration for dozens of products, among which colorectal cancer and gastric cancer blood methylation detection products are the first approved in China, which have been applied to hundreds of tertiary hospitals and included in medical insurance in many places. The company has a rich product pipeline, including POCM series products, esophageal cancer early diagnosis products, liver cancer early diagnosis products, lung cancer early diagnosis products, NGS multi-cancer screening projects, stroke and other cardiovascular and cerebrovascular diseases early diagnosis and treatment projects.

At present, more and more companies are participating in early cancer screening and early detection, and the testing methods that can be provided are becoming more and more abundant, and this is the power of business for good.

Perhaps we can see in a shorter period of time that these IVD companies have popularized the awareness of early screening and early testing to every Chinese person.

Cancer won't go away, but we won't have to be afraid.

This is the ultimate value of early screening and early testing.

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