Hwa gene released a clarification notice for Hua Da cancer report

Hwa gene released a clarification notice for Hua Da cancer report

Sina Technology News July 13th news, today, the media published the title of "China big cancer" report, the report on non - invasive prenatal gene detection technology and Chinese major gene related business questions, China big gene announcement to respond.

The following is the original announcement

1. Media coverage

Recently, Shenzhen Hua Da gene Limited by Share Ltd (hereinafter referred to as "Hua Da gene" or "company") concerned some websites, WeChat public number in July 13, 2018 issued the title of "China big cancer" report (hereinafter referred to as "the report"). The report has questioned the technology of non-invasive prenatal genetic testing and related business of the company.

Two. Clarification

In order to avoid the misleading of the report, the company has carefully checked the content of the media reports and clarifies the following:

(1) introduction of noninvasive prenatal gene detection technology

Compared with traditional Down's screening technology, noninvasive prenatal gene detection is highly accurate. Several large-scale clinical trials have proved that non-invasive is highly sensitive and highly specific. The 2015 international authoritative journal "The New England Journal of Medicine" published a prospective, multi center and double blind trial analysis of 15841 samples. The study showed that non invasive prenatal gene detection was significantly better than traditional serological screening, with higher detection rate and lower false positive rate (Norton et.al.2015).

In the same period, New England Journal of Medicine published an article "Accurate description of DNA-based noninvasive prenatal screening". A, Leung T Y, 2015).

From 2011 to date, several industry associations, including the American Society of Obstetricians and obstetricians (ACOG), the American maternal Medical Association (SMFM), the American Association for genetic counseling (NSGC) and the American Medical Genetics Society (ACMG), have issued guidelines for the clinical application of noninvasive prenatal gene detection and committee guidance. "Noninvasive gene detection can replace traditional trisomy syndrome screening techniques at different ages, and suggest that all pregnant women should be informed of the 21, 18, and 13 triad syndrome. Noninvasive genetic testing is the most sensitive testing technique at present," ACMG declared. ACOG and SMFM issued a consensus that "noninvasive prenatal screening of maternal plasma free DNA provides great potential for fetal aneuploidy screening." In China's eighth edition obstetrics and Gynecology textbooks, noninvasive prenatal genetic testing is included in the screening of 21- trisomy syndrome.

At present, some countries and regions in the world have used non-invasive prenatal genetic screening as a first-line screening tool. In July 15, 2015, Switzerland provided mandatory medical insurance for high-risk pregnant women to reimburse the cost associated with noninvasive genetic testing. This is the first time in the world to incorporate non-invasive prenatal genetic testing into the national health insurance system. In January 2016, the British National Screening Committee (NSC) said that noninvasive genetic testing was expected to be incorporated into the British national medical service system in 2018 or 2019.

At the national level, relevant policies and regulations have been promulgated to support and standardize the clinical application of noninvasive genetic testing. In 2016, the State Health Planning Commission issued the notifications of the State Health Planning Commission's office of the National Health Planning Commission on the standardized and orderly conduct of prenatal screening and diagnosis of fetal free DNA in maternal peripheral blood. In China, non-invasive prenatal genetic testing is also used as a first-line screening paradigm. Shenzhen has incorporated non-invasive prenatal genetic testing into public health projects. The application of non-invasive gene detection has made great progress in the prevention and control of Down's syndrome in Shenzhen. According to the data from the maternal and child health care hospital of Shenzhen, with the opening of the two - child policy and the increase of the older women, the total incidence of the Shenzhen Down's syndrome has risen obviously in 2011-2017 years, from 4.70/ million in 2011 to 11.64/ million in 2017, but under the joint efforts of the medical departments at all levels in the city, 2011-20 of them have been effectively intervened, 2011-20 In the 17 year, the production rate of Tang's descending is very obvious, from 2.36/ million in 2011 to 0.84/ million in 2017, which has achieved remarkable social benefits.

(two) whether the company has exaggerated publicity about the effect of noninvasive prenatal gene testing.

Noninvasive prenatal gene detection has been defined as a prenatal screening technique for fetal chromosomes. The population is suitable for people who are suitable for down screening. If the results are high risk, or the results are low, the prenatal diagnosis is required after the detection. Chorionic villus, amniocentesis (amniocentesis), percutaneous umbilical vascular puncture combined with karyotype analysis are prenatal diagnosis techniques, which are invasive testing for people with prenatal diagnosis, and prenatal diagnosis is still the basis for abnormal diagnosis of chromosomes. In 2016, the State Health Planning Commission issued "the notice of the Health Planning Commission on the standardized and orderly conduct of prenatal screening and diagnosis of fetal free DNA in maternal peripheral blood". The following requirements are made as follows: "inform the detection rate, false positive and false negative rates of this technology, and emphasize that the results are not." It is the result of prenatal diagnosis. High risk results must be diagnosed by interventional prenatal diagnosis, as well as the cost and process of detection. "

Noninvasive prenatal gene detection may be false positive and false negative as a screening method for abnormal aneuploidy on chromosome 21, chromosome 18 and chromosome 13. In 2016, the State Health Planning Commission issued "the notice of the Health Planning Commission on the standardized and orderly conduct of prenatal screening and diagnosis of fetal free DNA in pregnant women." the detection rate of conventional chromosomal aneuploidy has been required: 21 trisomy, 18 trisomy, and 13 trisomy detection rates are not less than 95%, 85% and 70%, not 100%. The Huada gene also strictly adheres to the national regulatory requirements, and is clearly informed of the scope and technical limitations of noninvasive genetic testing in the relevant noninvasive informed consent. As noninvasive gene testing is a risk of false negative screening as a screening technique, in order to protect the subject, Hua Da Ji buys medical insurance for every subject.

(three) on the specific business matters of the company

Hua Daji has provided basic research services for the China National Tobacco Corp and its subsidiaries, which mainly undertake genome sequencing and biological information analysis, and the cooperation of both sides belongs to the scientific research category. Through the study of tobacco genome and smoking population, the tobacco breeding is improved, and the gene loci of the high-risk population of smoking are screened, the risk of smoking is reduced better, and the early warning to young people or smokers is made in advance, so as to achieve the effect of accurate prevention and positive social guidance.

Three. Special hints

The company has solemnly reminded the investors that the information disclosure media designated by the company are "China Securities newspaper", "Securities Times", "Shanghai Securities Daily", "Securities Daily" and "http://www.cninfo.com.cn". All the information disclosure of the company is based on the announcement published in the designated media. We invite investors to invest rationally and pay attention to investment risks.

This is hereby announced.

Shenzhen Huada gene Limited by Share Ltd board of directors

July 13, 2018

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