As someone who had read one of the many articles hyping Theranos and its CEO, I found this thread to be very informative. This SDN thread is the first result that Google returns when I type in "theranos skeptical."
I am interested in hearing your opinions on a section from the Fortune magazine article on Theranos. I've pasted the relevant paragraphs below:
What do incumbent players in the blood-diagnostic space think about all of this? The most frequent criticism is that Theranos is using purportedly breakthrough technology to perform tests that are relied on for life-and-death decisions without having first published any validation studies in peer-review journals. “I don’t know what they’re measuring, how they’re measuring it, and why they think they’re measuring it,” says Richard Bender, an oncologist who is also a medical affairs consultant for Quest Diagnostics, the largest independent diagnostic lab.
Holmes counters that because, as noted, her tests employ “the same fundamental chemical methods” as existing tests, peer-review publication of validation studies is both unnecessary and inappropriate.
The backdrop for this dispute is an unusual regulatory structure that does, in fact, confer upon some–though not all–conventional lab tests an extra layer of validation that Theranos’s do not yet have. Most labs, like Quest and Laboratory Corp. of America, perform many of their routine tests using analyzers they buy from medical-device manufacturers, like Siemens, Olympus, and Beckman Coulter. Before those manufacturers can sell such equipment, they must obtain U.S. Food and Drug Administration approval for the tests those analyzers perform–a process that is in addition to, and more searching than, the audits and proficiency tests required to win CMS certification for the lab itself.
At the same time, for other procedures conventional labs will devise their own lab-developed tests, or LDTs, which they do not have cleared by the FDA. While the FDA takes the position that it could require approval for LDTs, for many years it has said it would forgo that right in the exercise of its “enforcement discretion.”
Theranos, which does not buy any analyzers from third parties, is therefore in a unique position. While it would need FDA approval to sell its own analyzers to other labs, it doesn’t do that. It uses its analyzers only in its own CMS-certified lab. All its tests are therefore LDTs, effectively exempt from FDA oversight.
Holmes sees no basis for criticizing Theranos for acting within this framework, since no other labs seek FDA approval of their own LDTs. “Existing labs use thousands of assays that are neither FDA approved nor peer reviewed,” she says, referring to their LDTs. (In fact, the American Clinical Laboratory Association, the trade group for traditional diagnostic labs, adamantly opposes any effort by the FDA to start requiring approval of LDTs and even takes the position that the FDA lacks legal authority to do so.)
Do people here think that the traditional diagnostic labs will now want to have FDA approval for their LDTs? Thanks for any insight on this.
