Gene sequencing rules to tighten

China is strengthening the regulation of gene sequencing in clinical applications, which has long thrived in a gray area with no official approval.

No medical institute can practice gene sequencing in clinical applications before official standards and regulations are issued.

Those that have started must cease the practice, according to a circular issued by the China Food and Drug Administration (CFDA) on February 9.

Medical instruments, reagents and other products involved in the technology can only be used after approval from the CFDA, following the regulations for each kind of product. Those already in use but without any approval should be immediately stopped, said the circular.

It claimed that to ensure the safety of gene sequencing products, authorities will organize experts to research the issue while strengthening the management of the technology.

More than 200,000 pregnant women used the technology to detect whether their unborn babies have birth defects, the Legal Weekly reported in August, 2013.

The report said that genetic testing services are mostly provided by two major genetic technology companies, BIG Tech and BerryGenomics, with heads of the companies once claiming publicly that their service was in a legal limbo.

Gene sequencing technology is commonly seen in high-end medical check-ups in China, The Beijing News quoted a CFDA official as saying. The technology is not listed in the catalog of approved medical projects in Beijing.

CFDA authorities said that many products used in genetic testing are not approved based on regulations and the technology is not certified to be clinically applied, reported The Beijing News Tuesday.

As of press time, BIG Tech, a major provider of the service, did not reply to a request as to how it will respond to the circular from the Global Times.

Wang Wei, a former manager from BIG Tech said that they could not find a way to register, without specifying the reason, according to the Legal Weekly.

American actress Angelina Jolie announced in May 2013 that she had undergone genetic testing and discovered that she was highly susceptible to breast cancer. This led to her decision to have a double mastectomy.

Steve Jobs, former CEO of Apple, spent $100,000 on whole gene sequencing to learn the DNA sequence of his genome and that of the tumors killing him.

Song Ruilin, executive president of China Pharmaceutical Industry Research and Development Association, said that the CFDA is not questioning the technology, but stresses governmental approval of the clinical practice, which is a must for any new technology.