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FDA: plans to overhaul the diagnostic service market
2014-08-04
来源：转载自第三方
The US Food and Drug Administration (FDA) announced today that it plans to standardize thousands of diagnostic tests, including many heavy studies from the field of genetic testing. For a long time, the US Food and Drug Administration (FDA) turn a blind eye to them. Now the FDA will take action to regulate this market.
In the United States, more than 2,000 independent laboratories carry out more than 11,000 tests, they will soon enter the FDA's standardized documents, FDA will upload the document to Congress, so that it is legally binding. "This is just as safe and effective as medicine and medical devices," said Commissioner Margaret Hamburg at a meeting.
The new policy stipulates that the relevant diagnostic testing services require a large number of samples to be tested, and if it is involved in the use of medical devices, they should also be FDA certified.
And some diagnostic testing services will be excluded from the new requirements, for example, in the treatment of rare diseases, they are often due to the lack of a large number of sample tests, and was the new request "pardon". In fact, the new policy will likely have a significant impact on the use of genetic testing to treat patients.
The use of DNA sequencing to treat rare diseases, FDA still gives a green channel, from the impact of these policies, but for cancer genetic testing, will become the object of FDA rectification. Perhaps the world's leading manufacturer of DNA sequencers Illumina should pay close attention to it because most of the sequencers produced by the company are used to detect cancer in the patient. In 2013 Illimina ranked first with 53% market share, followed by LifeTech 38% and Roche 8%. If this bill is true, then there will be greatest impact on Illimina.
TAG: Chemical Reagents, Biomedicine
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