On January 20, 2015, former US President Barack Obama proposed to conduct research on precision medicine, which marked the beginning of precision medical research in developed countries represented by the United States. Later, with the encouragement of the national leaders and the support of relevant favorable policies, China's precision medical research was launched immediately, and major special projects for precision medicine have been established. As an important part of precision medicine, gene detection has also developed rapidly in recent years.

Yesterday, sponsored by Gene Hui, the “2018 Guangdong-Hong Kong-Macao Dawan District Life Health Innovation Forum and Gene Industry Mid-year Conference” was held in Shenzhen Qianhai Bay. At the conference, 30 industry experts from policy, research, clinical, industry and capital brought 14 dry goods sharing and 4 special discussions. Among them, six guests including Gu Weifu, the founder of Gu Dafu Studio, discussed the topic “How can genetic testing go to the routine medical test?”

Differences and boundaries between genetic testing in medical and health consulting applications

The effects of various diseases on individuals vary from birth defects to middle-aged diseases, covering the entire life cycle. Genes are the link between medical and health, which highlights the importance of genetic testing.

Genetic testing can be used in the medical field to diagnose and screen diseases, but it can also be used for health counseling to help people predict disease risk. At the current stage, genetic testing of patients (genetic diseases and tumors) and direct-to-consumer (DTC) genetic testing have a clear boundary.

So where are the differences and boundaries between genetic testing and medical and health consulting applications? In the view of Xingbo bio-CEO, Chai Yingshuang, to distinguish the boundaries of genetic testing in medical and health counseling applications, it is first necessary to distinguish who is the recipient of genetic testing. If the recipient of the genetic test is a clinician, then for the doctor, he will pay more attention to the validity and practicability of the genetic test, because the doctor uses genetic testing as a diagnostic tool. If the recipient is an ordinary citizen, then the people may need more than just the results of the genetic test report, but the problem of follow-up examination and treatment after the results are obtained.

But in the future, such boundaries may become blurred with the development of technology and industry, and will merge in some parts. At the meeting, Gu Weihong said that in the future, genetic testing agencies for disease diagnosis can try to enter the health field to ablate the border. At the same time, these institutions will use the awe of the original medical care to promote the development of the entire genetic testing industry.

Clinical grade genetic testing should be hospital-led? Or a third-party testing agency?

With the significant reduction in sequencing costs and the significant increase in bioinformatics analysis capabilities, the development and commercialization of sequencing instruments, the establishment of supporting bioinformatics computing platforms, and the advancement of scientific research and clinical transformation in the field of genomes , in recent years, the scale of the gene sequencing market improve dramatically.

It is in this context that in recent years, third-party medical testing institutes have developed rapidly, and there are many testing projects in the hospital's laboratories and third-party medical testing institutes, and they have scale advantages. Traditional medical laboratories only provide medical tests and pathological diagnosis. However, with the maturity of genetic testing technology, some testing centers with medical institution resources have begun to provide special genetic testing services, such as Golden Field Testing and Dean Diagnostics.

Is the future clinical grade genetic test a hospital-led or third-party testing agency? Zhou Wenhao, deputy dean of the Pediatric Hospital of Fudan University, believes that from a long-term perspective, if the genetic testing is to become a "machine-oriented production", it must not be a hospital thing, and it is definitely necessary for third-party testing institutions to enter. And promote their development together. However, genetic testing is finally going back to the hospital to solve the problem, so the hospital and the third-party testing agencies should be more cooperative, each doing their job, and building the entire map of genetic testing.

The former FDA review leader Sun Liying believes that clinical grade genetic testing must be done by private testing agencies, because only by using the strengths of all parties can the entire industry be stronger and bigger, and if the genetic testing is still in the hospital Leading, hospitals and third-party testing institutions still have interest disputes and competitive relations, then China's genetic testing industry will certainly not develop.

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