Theranos Under Regulatory Microscope
Theranos has been in the news and has garnered both bouquets and brickbats because of its proprietary technology as well as its business model.
This company started by wunderkind Elizabeth Holmes and valued in the billions uses small samples of blood (often from a fingerstick) and runs tests on its own proprietary instrument. The value proposition is that they are able to obtain small samples, less painfully, and then turn out tests (including full panels) in less time and at far less cost than traditional labs.
Theranos is not without political clout as well. They were able to get the FDA to fast track approval of several of their tests. They also mounted a powerful lobby in Arizona to shove through a bill allowing direct access testing (DAT) whereby patients can order their own tests. There is a huge market for DAT.
Traditional medical laboratory scientists have long been suspicious of the claims made by Theranos. Very few have seen the wizard behind the curtain. Little or no data have been peer-reviewed and published. There have been reports of titular directors with doctoral degrees who are not medical laboratorians with the requisite knowledge and experience.
It was only a matter of time before employees or ex-employees blew the whistle. Largely as a result of complaints from 2 former employees, both the FDA and CMS are taking a closer look at Theranos. Of particular interest is the fact that the company was told to discontinue use of their miracle nanocontainers. Employees indicate that the Edison, the magic proprietary instrument at the very heart of Theranos, is in fact only used to run a handful of tests; most tests are run on traditional instruments. How do these instruments accommodate the tiny volumes that Theranos collects? The reports are that specimens are simply diluted to volume and then a dilution factor is applied (even for normal specimens.)
Then there is the little matter of supposedly flawed and manipulated data from study protocols. Proficiency tests are performed differently than patient specimens. The list goes on and on.
I love advancement in technology, including in the field of MLS. I embrace it. However if information is incorrect, or if data are being manipulated it is only ethical and just that such shenanigans be exposed.
What's the case with Theranos? We'll see.