The US Food and Drug Administration (FDA) recently announced that it will allow 23,Me, a startup, to sell its genetic testers directly to consumers, which can simultaneously detect the genetic risks of 10 diseases including Alzheimer's disease and Parkinson's syndrome. This long-awaited decision marks the official approval of the first home genetic testing equipment, which will create a new trend in DIY disease detection.
23andMe said it will provide this new service as soon as possible in the coming months. The company's chief statute officer, Keith Hibbs, said: "This is a watershed significance for both our company and the FDA." Since 2006, consumers have sent emails to the company to provide genetic features such as hair color. The analysis service, the company also provided a DNA detection device that can detect 240 kinds of health conditions at one time, but was urgently stopped by the FDA in 2013. Because the test results are not accurate, the FDA is concerned that consumers rely on the company's test information to determine the drug use plan at home, which may have serious consequences.
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In 2015, the FDA relaxed restrictions, allowing the company to provide testing services to prospective parents with genetic defects, but only to detect whether their children carry one of the 36 serious genetic genes, can not detect the risk of the prospective parents themselves.
This time, the FDA fully opened the green light to the company, allowing it to directly provide consumers with testing equipment, and can detect strong related genes including 10 diseases including Parkinson's syndrome, Alzheimer's disease, celiac disease and thrombosis. variation. Industry insiders welcome this. Stanford University bioethicist Hank Greeley said, "This shows that the cooperation between the genetic testing company and the FDA has taken a big step forward. Silicon Valley has long been in tension with the FDA, and believes that FDA's strict regulations are not conducive to life. Shaoguan's health industry development."
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