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The company is all hot air. They have a board full of retired military figure heads that have no experience in medical devices or retail services. Additionally, they do not have any products to show. Look at their patents. They are all very general and broad. There has been NO FDA CLEARANCE for anything they are doing, which raises legal questions. Speaking of legal, search for lawsuits they are involved in. Their core technology is not even theirs. They stole it from someone else.



While I have no idea if any of the other claims are true, it's important to note that they do claim to be regulatory-cleared (not FDA, not relevant in this case): they claim to be running a CLIA-certified lab.

CLIA (Clinical Laboratory Improvement Amendments)[1] defines the regulatory standards for clinical labs which take in samples and perform medical tests on them. It works very differently from FDA drug or device approval. Most often the certification is done by an organization such as the College of American Pathologists (CAP), which scrutinizes a lab's protocols and output[2].

In any case, if they are CLIA-certified they are open for business, legally speaking.

[1]: http://wwwn.cdc.gov/clia/ [2]: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_act...


The only lawsuit information I've found so far shows Theranos as the plaintiff, represented by Boies Schiller & Flexner LLP. That would be David Boies, fwiw.

Are there others?

Edit: Here's some background: http://www.leagle.com/decision/In%20FDCO%2020121203541


I would tend to agree. Nanomix (nano.com) has been trying to accomplish this for the past ~6 years or so. Combining a complex biological assay + micofluidics + high precision sensing technology is not a trivial task. I want to see some hard data verified from a third party.


I agree. Building a medical device and/or diagnostics company is not a joke.




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