Theranos phenomenon: promises and fallacies

Abstract

Abstract:Recently, spectacular advances in diagnostic technologies, genomics, etc. offer unprecedented opportunities for widespread testing of asymptomatic individuals, in the hope that this testing will unravel early disease signs which could lead to preventative or more effective therapeutic measures. In particular, one commercial organization, Theranos, promises to revolutionize diagnostics by offering multi-analyte testing at low prices in commercial outlets, thus challenging the current paradigm of targeted and centralized diagnostic testing. In this paper, I analyze the Theranos technology and their promises, and contrast this information with the currently used technologies, to show that most of the company's claims are exaggerated. While it remains to be seen if this technology will revolutionize diagnostics, in this Opinion Paper, I also draw attention of associated issues, such as self-testing and self-interpretation of results, over-testing, over-diagnosis and over-treatment, along with their associated harms. As the public is bombarded daily with new and revolutionary health-related advances, it is time to balance the enthusiasm of the seemingly obvious huge gains, by also explaining the associated possible harms.

Theranos phenomenon – Part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conference 2016

“…One of us (EPD) has already tested one of these new blood collection devices and found out that it was totally painless and collection time was less than a minute. These related technologies will likely be preferable to patients than fingerpricks, which, as we mentioned earlier, are more painful [1]. The video of Miss Holmes' presentation can be found at this link: https://www.youtube.com/ watch?v=n6JRG733ReQ.…”

“…This journal has followed the Theranos story closely over the last 2 years and provided frequent updates [1][2][3][4]. Elizabeth Holmes, the Chief Executive of Theranos, presented to an audience of over 2500 clinical chemists and other laboratory scientists, as well as to an impressive number of reporters from national and international media.…”

“…She avoided talking about Theranos' past and the difficulties of her company [1][2][3][4][5][6][7]. She also made it clear that her presentation would focus on the future, not the past, and she distanced herself from the previous "Edison" instrument and introduced a new analyzer named "MiniLab".…”

The Theranos phenomenon, scientific transparency and freedom of speech

“…What about the three other papers [1][2][3]? The first and most detailed paper in the series deals with several facets of Theranos, including the fact that the methodology developed by the company had never been presented to the scientific community and therefore could not be judged.…”

“…Since July 2015 Clinical Chemistry and Laboratory Medicine (CCLM) has published a series of four articles on the up-and-coming laboratory diagnostics enterprise Theranos, (co)authored by one of the members of our editorial board, Eleftherios Diamandis [1][2][3][4]. There were two opinion papers and two letters to the editor.…”