Theranos was founded by Stanford Elizabeth Holmes has generated catalyzed a lot of talks for coming up with a revolutionary approach to the blood test. The company is built around a proprietary sophisticated diagnostics lab that paves way for a variety of blood tests. According to Holmes, this innovation was going to accomplish three major things: faster, cheaper and better, as such, this innovation has a potential to influence an industry (Carreyrou ,2015).
Theranos's technology runs any different combination of tests at once and very quickly and it does all this from a single micro sample. Ms. Holmes states that patients will no longer wait for days for the results to be released as this will only take approximately two hours. Notably, less blood is expected to be drawn from patients as compared to a traditional method that requires different samples in order to carry out blood tests. Most patients are reluctant in providing blood sample due to traditional large syringes that scare them away especially children meaning that the manufacturer of this syringes will lose revenue with time. Another thing that will give Theranos a competitive edge is the testing accuracy. Labs do purchase lab instruments from different manufacturers and precision of these instruments and their references vary from manufacture to manufacture (Carreyrou ,2015).
This has provided many opportunities for error during testing as labs do not calibrate machines to each other after purchasing from different vendors. Ms. Holmes technology is designed to remove potential human error from the process as the technology is automated and highly standardized. Most patients want the disease to be identified earlier before the onset of the symptoms and with such speed and better information that comes with the invention; the company will attract more customers. The traditional method of blood tests does not allow doctors to analyze the data longitudinally in order to see clusters, rates, and trends in the blood sample provided something Theranoss tool is capable of doing. Scientifically, is some of the diseases are detected earlier; they can be cured as compared if identified at later stages. At the same time, doctors are able to identify actionable information to come up with probable diagnosis at the right time.
However, the company has struggled behind the scene in turning this technology into reality and what it had focused on was not accomplished. Fundamentally, the blood was collected into a nanotainer where the tool was to carry out a dozen of tests on those few drops of blood. The company did not reveal how the machine works citing it is private. As such, FDA was not able to identify if lab procedures were being followed. This was a concern from the clinical perspective since such a shotgun approach to medical testing is a bad medicine. When you run the different test without a sign of a disease, it automatically leads to false positive results. Theranos was carrying out most of its taste using a traditional machine instead of its Edison device. the device was designed to produce results over a short period of time but this did not work as the company relied on traditional method in carrying out most of its tests with various allegations from Wall Street journal regarding Edison devices, the company was not able to provide substantial prove which meant that its technology was not working (Plebani,2015)..
FDA after carrying out a long investigation called nanotainer, an uncleared medical device, and the company was forced to stop using it. Laboratory tests should base on blood taken from a vein, not from the finger. The human body has a series of compartments and the concentration of molecules in blood is not the same in this compartments. One molecule such as glucose can be found in various compartments but medically important molecules such as lipid and proteins are evenly distributed in these compartments. As such, the composition of blood from finger pricks may be different from that obtained from the veins. The company lost a lot of revenues after this revelation as most patients shifted on a traditional way of blood tests. This paved way for other manufacturers to continue dominating the industry as their equipment are vetted by FDA before being sold to various labs (Diamandis, 2015).
The company made a big mistake for not revealing how it does a vast majority of its tests and how journalists were handled when they wanted to interview Ms. Holmes. For five months, the Ms. Holmes did not speak to the journalist who wanted answers and yet her former employees had revealed some secrets of the company. The Wall street journal was behind the scandals that faced Theranos as it published a lot of articles regarding the company until other medical agencies and experts including FDA came in to carry out investigations into the allegations. Companies should learn on how to respond to allegations raised in advance in order to win the public trust and o avoid suspicion especially if the company through the CEO skip interviews.
References
Carreyrou J. (2015). A Prized Startup's Struggles --- Silicon Valley lab Theranos is valued at $9 billion but isn't using its technology for all the tests it offers. Wall Street Publisher.
Retrieved from HYPERLINK "http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-" http://www.wsj.com/articles/theranos-has-struggled-with-blood-tests-1444881901
Diamandis, E. P. (2015). Theranos phenomenon: promises and fallacies. Clinical Chemistry and Laboratory Medicine (CCLM), 53(7), 989-993. Retrieved from http://sites.utoronto.ca/acdclab/pubs/mentoring/20.pdfPlebani, M. (2015). Evaluating and using innovative technologies: a lesson from Theranos?.
Clinical Chemistry And Laboratory Medicine (CCLM), 53(7). http://dx.doi.org/10.1515/cclm-2015-0411
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