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February 20, 2014

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New rules on genome sequencing designed to ensure best practice

HEALTH authorities are set to introduce new rules governing the clinical practice of genome sequencing, and use of associated products and technologies.

According to a notice issued by the State Food and Drug Administration, all genome sequencing machines, reagents and medical-use software and appliances must be registered with the FDA, while all clinical practices must be approved by the National Health and Family Planning Commission.

The new rules are designed to better regulate the industry, especially in relation to prenatal genome sequencing, the notice said. Any clinical work that is under way but not approved must be halted immediately, it said.

Genome sequencing is a valuable diagnostic tool that has helped doctors to identify rare diseases. But concerns remain about its use.

“The key is to regulate the practice to prevent abuse,” Dr Jiang Zhongyi, president of the Shanghai Children’s Medical Center, said.

“Some facilities are using the costly procedure for routine health checks or to help predict children’s potential abilities,” he said.

Genetic diagnosis and treatment is a big step forward for medicine, and an alternative to evidence-based medicine, Jiang said.

“In the past, doctors had to base their treatments of complicated diseases on symptoms. But now we can witness the exact cause on genes and intervene,” he said.

“In developed countries like Japan, experts have already begun using gene therapy to cure diseases.”

A laboratory at the children’s center that has already been approved for genome sequencing has been widely used for clinical diagnosis, he said.

Officials from the Obstetrics and Gynecology Hospital of Fudan University said they were satisfied with the strict access standards. The hospital is considering introducing genome sequencing for prenatal checks, especially to aid the detection of Down’s syndrome, it said.

Similarly, the Shanghai Landseed Hospital said that since reading the SFDA notice it  has suspended all procedures relating to genome sequencing.

The hospital does not carry out the sequencing, but collects samples from patients, which are then passed on to a company that does, it said.



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