Colorectal cancer stool DNA detection technology is launched in China!

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Colorectal cancer stool DNA detection technology is launched in China!

Colorectal cancer stool DNA detection technology is launched in China! What is the impact on critical illness insurance?

Foreword

Colorectal cancer accounts for about 10% to 13% of all cancers in the middle-aged and high-age insurance population. It is a relatively high-incidence cancer, and most of them evolves from potentially malignant adenomatous polyps. The occurrence of this cancer is closely related to the currently quite common unhealthy lifestyle and eating habits, such as long-term high red meat, high refined carbohydrates, low fiber diet, smoking, obesity, lack of exercise, etc. Therefore, many countries, including China, have issued screening policies for high-risk groups, to achieve the effect of early detection and early treatment. In November 2020, Nuohui Health’s product, multi-target colorectal cancer fecal occult blood, and DNA detection reagent “Chang Weiqing” was approved by the Food and Drug Administration, becoming the first officially approved early-stage cancer screening product in China.

According to historical data, in the Chinese population, colorectal cancer deteriorates at a rate of about 1% to 2.5% per year, and the deterioration of men is faster than that of women, which partly reflects the fact that men’s eating habits are generally worse than women’s. The trends among the insured population are largely in line with the general population.

Benefits of Colorectal Cancer Screening

The utility of cancer screening is related to the rate of disease progression for each cancer, as well as differences in cancer survival by stage. The five-year survival rate for early-stage (TNM stage 1) colorectal cancer is quite high, reaching 90 %, but only about 14% for advanced (TNM stage 4) colorectal cancer. In addition, the progress of this cancer is relatively slow. It may take about 10 years or even longer from the appearance of adenomatous polyps to the final development of cancer. Therefore, regular screening can effectively detect and treat early in the early stage of disease progression. , has obvious benefits to the health of the population.

The definition of the population recommended for screening varies from country to country. According to the latest “Guidelines for Colorectal Cancer Screening, Early Diagnosis and Treatment in China (2020, Beijing)” initiated by the National Cancer Center and released at the end of 2020, the recommended groups for screening are:

  • People aged 50-75 who are assessed as low to moderate risk
  • People aged 40-75 who are assessed as high risk

High risk was defined as a first-degree relative with a history of colorectal cancer (including a family history of non-hereditary colorectal cancer and family history of hereditary colorectal cancer), a history of colorectal cancer myself, and a history of intestinal adenomas, or other related diseases, etc.

Introduction to Colorectal Cancer Screening Technology

The main screening techniques and features are as follows:

screening technology

feature

“Immune Fecal Occult Blood Test” (FIT)

Detection of human hemoglobin in specimens is the current mainstream early screening technology.

Guaiac fecal occult blood test” (gFOBT)

Previous generation detection technology. Less sensitive, susceptible to diet and drug effects.

Multi-target Fecal DNA Detection Technology (mt-DNA)

It is not limited to hemoglobin, and simultaneously detects multiple targets such as DNA mutations.

Colonoscope

The gold standard for screening and diagnosis.

Sigmoidoscopy

Bowel screening is less extensive than colonoscopy.

Colon CT

Computed imaging, non-invasive. Higher cost.

A positive fecal occult blood test requires further colonoscopy to confirm the diagnosis. That said, the fecal occult blood test by itself does not constitute a definitive diagnostic criterion for colorectal cancer. In addition, the sensitivity of FIT for the detection of polyps is not high, and its diagnostic performance for precancerous lesions is limited.

Multi-target colorectal cancer stool DNA (mt-sDNA) detection: Chang Weiqing

FIT detects only one marker, hemoglobin, in the stool. However, in recent years, with the further understanding of the mechanism of gene mutation in the process of cancer progression, various other markers contained in human blood, urine, feces, etc., such as DNA mutation, DNA methylation, RNA, cancer cells, etc., have been found. Fragments that fall off are closely related to the process of carcinogenesis and can become the detection targets of the next generation, playing a role in the early screening and diagnosis of cancer. Simultaneous detection of multiple targets can also improve sensitivity, making cancer easier to screen for.

NovoHealth’s multi-target colorectal cancer fecal occult blood and DNA detection reagent “Changweiqing” has been approved by the Food and Drug Administration in November 2020, and is the first officially approved early-stage cancer screening product in China. In mid-March this year, AstraZeneca China and NovoHealth signed a memorandum of cooperation and a promotion agreement for Chang Weiqing. The agreement stipulates that the two parties will jointly promote Chang Weiqing in domestic public hospitals, pharmacies, and Internet hospitals. The cooperation period is three years. In addition, Nuohui Health has also signed strategic cooperation agreements with JD Health and Ping An Health respectively to jointly promote the integrated solution of medical health and early cancer screening services.

Its several characteristics are 8:

  • Multi-target: In addition to detecting gene mutations and gene methylation, it also detects fecal occult blood;
  • Screening for high-risk groups of colorectal cancer aged 40-74 ;
  • Like FIT, it is a non-invasive detection method and is equally convenient;
  • The price is higher, the official website price is 1996 yuan.

In addition, in China’s first national cancer screening guideline “Guidelines for Colorectal Cancer Screening and Early Diagnosis and Treatment in China (2020, Beijing)” newly released in January this year, experts recommend multi-target fecal DNA as a colorectal cancer screening guideline. One of the methods of early cancer screening (“Recommendation 11.5”), can be seen that :

  • Recommendation 11.1: Colonoscopy is the gold standard for colorectal cancer screening (strong recommendation, GRADE: high)
  • Recommendation 11.2: FIT is suitable for colorectal cancer screening. It has high diagnostic sensitivity for colorectal cancer, but limited sensitivity for precancerous lesions (strong recommendation, GRADE: moderate)
  • Recommendation 11.5: Multi-target stool FIT – DNA assay can be used for colorectal cancer screening under certain conditions, and it has a certain screening ability for colorectal cancer and precancerous lesions ( weak recommendation, GRADE evidence ). According to rating: low )

Recommendations for screening cycles are:

  • Recommendation 12.1: We recommend high-quality colonoscopy every 5–10 years (strong recommendation, GRADE: high)
  • Recommendation 12.2: Annual FIT is recommended (strong recommendation, GRADE: moderate)
  • Recommendation 12.5: Multitarget fecal FIT-DNA testing every 3 years is recommended (weak recommendation, GRADE evidence: low)

Judging from foreign historical experience, in 2014, the US FDA approved Exact Sciences’ product “Cologuard”, which is also a multi-target fecal DNA test, for early screening of colorectal cancer, and included it in Medicare in the same year. Recommendations in screening guidelines are similar to those in China.

Impact on critical illness insurance and prospects

Compared with the mainstream FIT, how does Chang Weiqing perform? What impact does it have on critical illness insurance?

From the clinical test efficacy of the two:

 

FIT 9

Chang Weiqing 10

colorectal cancer

precancerous lesions

colorectal cancer

advanced adenoma

Sensitivity

83%

36%

95.5%

63.5%

specificity

90%

92%

87.1%

87.1%

High sensitivity means that if a person does have cancer, the probability of being correctly diagnosed with the disease is higher; high specificity means that if a person does not have cancer, the probability of being correctly diagnosed without the disease is higher. The diagnostic sensitivity of Chang Weiqing for colorectal cancer and advanced adenoma is significantly higher than that of FIT, but the specificity is slightly lower, which is consistent with the comparison results of a FIT and multi-target fecal DNA detection abroad.

What do the above values ​​​​specifically mean?

Based on the above, we can deduce that the false-negative rate of Chang Weiqing is low, which means that fewer cancer cases are missed. But on the other hand, its false-positive rate is higher than FIT, so it cannot be said that multi-target fecal DNA is a better detection technology than FIT in all aspects of diagnostic performance. It has a specific scope of application and limitations and is complementary to, rather than a substitute for, the current mainstream FIT. This is why FIT is the only strongly recommended screening technology other than colonoscopy in the recommendations on screening techniques and cycles in the Guidelines for Colorectal Cancer Screening, Early Diagnosis and Treatment in China (2020, Beijing), with multiple targets. Fecal DNA testing is a ” weak recommendation “.

For the insurance population, it seems that it should not be a potential tool for adverse selection at present, because its effectiveness in assessing their cancer probability is comparable to that of mainstream FIT, but the price is very different: Chang Weiqing’s official website The price is nearly 2,000 yuan, but the FIT is only about 20 yuan. In the product review report, the Food and Drug Administration has clearly stated that Chang Weiqing “cannot replace colonoscopy and cannot be used for tumor screening in the general population, and the test results of this product should not be used as the sole basis for clinical diagnosis in the process of clinical diagnosis.

“If it is used in non-“40-74-year-old high-risk groups of colorectal cancer”, the false positive rate will be higher, which may cause unnecessary worry for screeners and waste of medical resources.

What is the impact of the promotion of screening programs on the future trend of colorectal cancer incidence? As mentioned above, the development time of the disease from adenomatous polyps to malignant tumors may take more than 10 years, which is one of the slower progressing cancers; The longer the disease progression period, the better the chance of early detection and early treatment. From 2015 to 2017, Guangdong carried out a large-scale screening project for colorectal cancer. The implementation of this project has increased the detection rate of early ( first and second stage) colorectal cancer by 68.1% and the first stage by 114.4%.

In addition to those found in the polyp stage, timely removal of polyps can prevent the occurrence of cancer. Being detected in the carcinoma-in-situ or precancerous stages can reduce the overall critical illness benefit burden. The incidence of colorectal cancer in the United States began to decline around 1985, in part because of improved risk factors, unlike in China, where it is still worsening. According to a study on the impact of risk factors and screening on the incidence trend in the United States, the promotion of colorectal cancer screening will increase the incidence in the short and medium-term, but in the long run (about ten years or more), it will reduce the incidence of cancer in the population. The effect is obvious, as shown in Figure 14 below. In addition, because of the cancer-preventive effect of polyp removal, the risk of over screening for this cancer should be below, and it is more likely to occur only in people over 70 years of age 15.

In conclusion

As shown above, Chang Weiqing, because of its relatively high price and comparable efficacy to mainstream FIT, should not cause an increase in adverse selection among the insurance population. Colorectal cancer disease progresses slowly. Although early screening can increase the incidence in the short and medium-term, it can effectively control the further deterioration of the incidence in the long run. From the perspective of risk factors, it is expected that the deterioration of national diet and living habits will continue to increase the incidence of colorectal cancer over some time.

In 2019, the state promulgated “Healthy China 2030”, which clarified the goal of improving the overall five-year cancer survival rate (in 2022 and 2030, no less than 43.3% and 46.6%, respectively), and screening is the main means to achieve the goal. one. From the approval of Chang Weiqing and the official inclusion of multi-target fecal DNA in the screening guidelines, it can be seen that the field of early cancer screening is gradually maturing and standardized, and it is expected that more early cancer screening detection technologies will be launched in China in the future. , the possible impact on cancer incidence and critical illness insurance deserves our attention

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