By Cai Wenjun
BEIJING, July 5 (Xinhuanet) -- The first batch of qualified genome sequencing tools for prenatal checks was approved by the State Food and Drug Administration on Monday.
In a bid to regulate the industry, the agency in February called a halt to all genome sequencing in clinical practice and said that related appliances, reagents and medical-use software must be registered with the SFDA.
It said also that clinical practices must be approved by the National Health and Family Planning Commission.
Dr Duan Tao said yesterday he was delighted the new rules had been put in place and that the first batch of equipment had passed muster.
“Genome sequencing in prenatal checks can identify 99 percent of all Down’s syndrome cases,” the president of Shanghai First Maternity and Infant Hospital said.
“It also reduces the need for invasive practices such as amniocentesis,” he said.
Dr Li Ruzhi from the Obstetrics and Gynecology Hospital of Fudan University, however, said that while genome sequencing is an effective diagnostic tool for diseases due to chromosome variation it is not effective in identifying diseases caused by gene mutation.
“Genome sequencing is a useful tool and it is a trend for the medical development, but it shouldn’t be misused,” Li said.
Only people with positive results in primary screening or those with a risk of miscarriage as a result of undergoing amniocentesis should be put forward for genome sequencing, according to Li.
(Source: Shanghai Daily)