The first home gene detector in the United States is approved to go on the market

Source: Science and technology daily April 11, 2017, the US Food and Drug Administration (FDA) recently announced that 23 & me, a start-up company, is allowed to sell its gene detector directly to consumers, which can detect the genetic risk of 10 diseases including Alzheimer's disease and Parkinson's syndrome at the same time This long-awaited decision marks the first domestic gene detection device officially approved for market, and will create a new trend of DIY disease detection 23 & me said it would provide the new service as soon as possible in the next few months "It's a watershed for both our company and the FDA," said Keith Hibbs, the company's chief regulatory officer Since 2006, consumers have sent e-mails to the company asking for analysis services of genetic characteristics such as hair color The company has also provided a DNA detection device that can detect 240 kinds of health conditions at one time, but it was stopped by FDA in 2013 Due to the uncertainty of the accuracy of the test results, FDA is concerned that consumers can decide the drug use plan at home by relying on the company's test information alone, which may cause serious consequences In 2015, the FDA relaxed restrictions to allow the company to provide testing services for parents to be with genetic defects, but only to detect whether their children carry one of 36 serious genetic genes, not to detect the risk of their parents to be This time, the FDA has fully opened the green light to the company, allowing it to directly provide consumers with testing equipment, which can detect the highly related gene variation of 10 diseases including Parkinson's syndrome, Alzheimer's disease, diarrhea and thrombosis at one time Industry insiders welcome this "This shows a big step forward for the cooperation between genetic testing company and FDA," said hank Greeley, a bioethicist at Stanford University Silicon Valley companies have long had a tense relationship with the FDA, believing that FDA's strict regulations are not conducive to the development of health industries that are vital to life " Greer believes that other companies will follow up and provide similar services, and 23 & me will gradually expand the diseases involved in genetic testing However, this kind of test is not the same as medical diagnosis In addition to genetic variation, lifestyle, family history and environment, etc., it will bring disease risk The consumer's cognition of the test results is limited, and the test results at home should be informed to the doctor in time for help (BIOON Com)