For nearly a half-century, interrupted only by the Cultural Revolution, China promoted the growth of genetic testing to prevent and address birth defects through state-run hospitals, as well as charities and increasingly in recent years, private enterprises.
Then last month, China reversed course.
The China Food and Drug Administration posted a new regulation that immediately banned genetic testing—even previously approved services “including prenatal genetic testing, gene sequencing technology-related products, and cutting-edge products and technologies.” The far-ranging ban applies to “all medical technology applications requiring detection equipment, medical diagnostic reagents, and related software; and other products, such as for disease prevention, diagnosis, care, treatment, monitoring, health status evaluation, and prediction of genetic diseases,” according to a translation of the directive via Google Translate.
The regulation also requires government “registration” or licensing or all devices used in genetic testing before their “manufacture, import, sale, and use” is allowed in China.
While some tools long approved by the state, such as polymerase chain reaction (PCR) equipment, can still be used, the testing freeze has raised concerns that it may hinder cutting-edge genetic research at a time when its spread into medical practice has been encouraged in the West.
“There wasn’t any information released before the new regulation came out. Everybody got shocked,” Nanbert Zhong, M.D., an investigator with Peking University Center of Medical Genetics, Shanghai Children’s Hospital, and head of the Developmental Genetics Laboratory at the New York State Institute for Basic Research in Developmental Disabilities, told GEN. “Everything has stopped. Everything involved in sequencing using machines that have not been approved has been stopped. No one has an idea when it’s going to be reopened.
“This is really a pity to the field,” Dr. Zhong added.
He could not confirm unofficial speculation surfacing in research circles that China may continue at least some genetic testing on a pilot basis through the creation of three sites nationwide.
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