Comment by crassus
13 years ago
They'd be dead within the year without some hefty political backing. The FDA does not play nice with novelty, ask any biomedical startup founder.
13 years ago
They'd be dead within the year without some hefty political backing. The FDA does not play nice with novelty, ask any biomedical startup founder.
My experience in the space is that this is a mischaracterization of the FDA, but also misses an important point:
Theranos does not fall under the FDA's mandate in its current form. It is a CLIA-certified laboratory operation, regulated under CDC rules and scrutinized most likely by the College of American Pathologists(CAP). The CLIA/CAP scrutiny is very different from the FDA device/drug process, focusing on protocol and output. Even if they have novel technology, it is often classified as a laboratory developed test(LDT) and falls outside of the FDA's mandate (for now).
Many startups have achieved CLIA-certification without too much difficulty, from Foundation Medicine to Veracyte to Counsyl. It's totally reasonable and doesn't take too long.
With that kind of firepower (no pun intended) Ms. Holmes may be setting her sights on the larger World market. Lots of people to be helped beyond the borders of the USA.
Could she become the Elon Musk of the healthcare sector?
This, and the choice of board is perfect if you're trying to get military and VA contracts.