The FDA should go out and buy one of those $150,000 machines...ASAP...as mentioned before Quest Labs is ready to rock and roll...and already has a series of tests that utilize DNA...the era of the DNA test has arrived...and the practice of medicine, in additional to digital documentation, is also in for another roller coaster...the rapid movement of personalized medicine...BD 

image It's happening again: A new technology and breakthrough discoveries are equipping entrepreneurs with the tools to rattle the status quo.

It occurred 10 years ago when the Internet introduced radical new ways to communicate, be subversive, and sell things. Now it's the turn of gene-techs — the fledgling industry that's setting out to mine the DNA inside us.

"The recent explosion of genetic testing has blown the door off the old model of researchers testing one gene at a time and then taking it to the clinic," says W. Gregory Feero, senior adviser to the director of genomic medicine at the National Human Genome Research Institute in Bethesda, Maryland.

The panel called for the Food and Drug Administration to require tough evaluation standards to prove the usefulness and validity of these tests, and for a mandatory registry of all laboratory tests.  "We welcome responsible regulation," said David Agus, an oncologist at Cedars-Sinai Medical Center in Los Angeles and the cofounder of Navigenics. "There needs to be medical standards and a system for validating this information."

Quest Diagnostics, for instance, earns $1 billion a year from molecular diagnostic testing, which includes dozens of DNA tests.

You 2.0: Closing the Genetic Gap

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