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Press Start: Lead an Empowered Life as a Clinical Laboratorian

Theranos Under Regulatory Microscope

Published December 22, 2015 8:04 PM by Glen McDaniel

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. 

3 comments

The hallwark of science is to use only proven methods. Science is also very transparent. Each theory is tested over and over and over and independently. Theranos is a big secret.

I feel this does a discredit to medical lab science as well. To even suggest anyone can make some claim totally unsubstantiated and make millions from it. Shame on the FDA  for their bias influenced by big money.  

This speaks also to the need for personnel licensure. If Theranos hired only licensed MLS/MLTs best practices they would automatically use best practices and not be goaded into things like diluting micro samples to get the right volume for assays. Practices like these speak to the  lack of sound scientific background  and ethics of people who do that stuff.

Gina Tobias December 26, 2015 8:12 PM
Boston MA

Now why would just this one company have this technology. Even companies that discover a certain methodology find very soon someone else find sit as well. They might be first and have  a patent but there are few unique secret technologies out there.%0d%0a%0d%0aThis is all very suspicious. I am also troubled by the fact that the scientific directors are not medical lab scientists. MLS is not the same as pure science and is definitely NOT medicine. You need the right expertise to make it work.

Melvin December 23, 2015 7:45 PM
Council Bluffs IA

It's about time. To me the problem with Theranos is that they are not forthcoming at all. They hit back like Donald Trump when they receive criticism, but don't give any evidence for their claims. When Ms. Holmes appears on TV it's only to say what a genius she is. She never addresses any of the science. I know she is not a scientist, but she could answer basic questions and maybe bring a MLS on to answer questions.

Missy T, MLS December 22, 2015 8:59 PM
Miami FL

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