Aggregated News
When the FDA shut down biotech company 23andMe’s direct-to-consumer Personal Genome Service, many in the biotech community worried that the FDA was risking the survival of a nascent industry that would revolutionize medical care with new genetic technologies. But lost in the story about 23andMe was the news that the FDA had just issued its very first approval for a next-generation DNA analysis machine, clearly signaling that the agency recognizes the growing significance of genetic testing in medicine.
The FDA approved a machine called the MiSeqDx, “the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome.” For a few hundred dollars, this little machine can analyze an amount of DNA in 24 hours that, 10 years ago, would have taken a dozen machines two weeks and cost nearly a million dollars. The rate of improvement in our technical capacity to read out DNA has been stunningly rapid, outpacing even the expectations of Moore’s Law, the gold standard for progress in the computer industry. Biomedical researchers can now consider ways to...
The FDA approved a machine called the MiSeqDx, “the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome.” For a few hundred dollars, this little machine can analyze an amount of DNA in 24 hours that, 10 years ago, would have taken a dozen machines two weeks and cost nearly a million dollars. The rate of improvement in our technical capacity to read out DNA has been stunningly rapid, outpacing even the expectations of Moore’s Law, the gold standard for progress in the computer industry. Biomedical researchers can now consider ways to...