Genetic testing has grown to be a organization huge adequate in China to warrant the government’s intervention. Early in February, the government quietly put the brakes on the provision of genetic tests to buyers by domestic hospitals and a variety of medical and health institutions.
If the ban persists it could blunt the ambitions of Shenzhen-based mostly BGI, which has the world’s greatest gene-sequencing capability, and its various competitors, such as Beijing-based Berry Genomics, Hunan-based 2nd Xiangya Hospital of Central South University, and Shenzhen-listed DAAN Gene. (For much more on BGI’s history and businesses, see this Forbes Asia magazine story). BGI itself is in the approach of getting ready for an IPO to list element of its business.
BGI declined to comment on how the ban would have an effect on its organization. It is understood the organization is in the process of searching for government approval for the commercial use of its items, such as its proprietary sequencing application and the Comprehensive Genomics-branded products created by the American organization it acquired a 12 months ago. An approval would permit it to sell its noninvasive DNA test, invented in 2010, which screens a fetus for Down syndrome by testing the mother’s blood.
The ban has created the country’s regulation of genetic testing – which existed till now in a legal grey location – between the most stringent, going beyond the U.S. Meals and Drug Administration’s latest action in stopping a U.S. company, 23andMe, from giving health-connected genetic exams right to shoppers.
The authorities seem to be most concerned about DNA-based mostly prenatal testing. Even although the government is comforting its notorious population controls to cope with an aging population, many Chinese dad and mom still have only one youngster, and want to make sure its overall health if not its intercourse and other traits. Now providers of genetic exams, with some exceptions, will have to apply for particular permission from government companies to perform such tests.
BGI President Wang Jian
Prenatal testing is the most common in the nascent company of genetic testing in China. A Chinese securities analyst estimates its market to be well worth 50 billion yuan ($ eight billion) a year, primarily based on the quantity of expected births and a testing charge of 3000 yuan ($ 480) every single. A much more sensible figure may be about 480 million yuan (US$ 77 million), the amount invested by the 160,000 girls who have taken the exams given that they were created offered in China. In the United States, the comparable marketplace is estimated to be well worth upward of $ one.3 billion a 12 months.
The official ban was produced by means of a cross-company announcement posted on the web site of the China Food and Drug Administration. The vague wording of the announcement can make it unclear how extensively it would apply to distinct types of genetic testing, but it names prenatal DNA exams as an illustration of those subject to the ban. It applies to all existing tasks except people accredited by the government, and requires all connected medical units to be licensed by the government before they can be produced, imported, offered or employed, possibly covering the world’s most popular gene-sequencing equipment, made by Boston-primarily based Illumina, Inc.
From now on, clinical applications of gene-sequencing technologies can be supplied only at locations accredited as pilot trial points by the National Wellness and Arranging Commission, the Chinese population handle authority. And they have to be accomplished according to rules, with “proper certifications and evaluations.”
Other than that, a blanket ban is enforced. “Before related certification and rules are promulgated, health-related institutions cannot carry out clinical applications of gene sequencing. These ongoing projects have to stop right away,” the announcement states.
In the announcement the government raises its concerns about the rapidly improvement of genetic testing as it has moved from labs to clinical applications. “Many genetic testing products and technologies, these for prenatal testing integrated, belong to the fields of pioneering study studies. They pose troubles in issues this kind of as ethics, privacy, the safety of human heredity assets, biological security, as properly as the management of diagnosis skills of relevant healthcare institutions, their pricing policy and quality controls,” it states in a extended run-on sentence.
Before the ban, Chinese overall health clinics had supplied consumers a proliferation of genetic tests for the diagnosis of different diseases, from tumors and diabetes to immunity system deficiency and hearing impairment. In Shenzhen, in which BGI has its headquarters, a key newspaper estimated the ban on prenatal testing would result in the birth of some eleven,000 infants with congenital problems, based on a total of 210,000 infants born final 12 months in the city and a nationwide birth defect fee of 5.six%.
Earlier, Chinese newspapers reported that BGI’s DNA-based prenatal testing for Down syndrome was getting censured by the government soon after an anonymous letter accused it of employing testing gear that was not certified by the government. The products in query, ironically, is the industry’s most sophisticated model, Hiseq2000, made by Illumina.
China Cracks Down on DNA Testing
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