Elizabeth Holmes had a proposition when she founded Theranos in 2003.
She aimed to disrupt the multi-billion dollar blood testing industry and revolutionize the healthcare sector by developing and commercializing a technology that would streamline the different processes involved in testing blood samples.
The product of this vision was the Edison and MiniLab devices.
However, damning information about the company surfaced in 2015 that revealed a web of deception and misconduct. The fate of Theranos was sealed
The flagship Theranos devices were nothing but a sham. The company ceased operations in 2018. Holmes, its founder and chief executive, and Sunny Balwani, its former president and chief operating officer were convicted of fraud in 2022.
What was the problem with the Edison and MiniLab devices?
An In-Depth Look: What Were the Edison and MiniLab Devices Supposed to Do? What Were the Reasons They did not Work?
Theranos and its Blood Testing Tech
Holmes had an idea about a next-generation technology for blood testing. She envisioned developing a device that could perform multiple tests or specific immunoassays with a drop of blood and without using a syringe.
The blood testing industry is complicated. Thousands of companies from around the world are involved in the different small facets of collecting and analyzing blood samples.
Examples of these firms range from producers of testing devices, specific developers of components, producers and sellers of auxiliary components, device distributors, and collection and analysis clinics and laboratories, among others.
Adding to this is the fact that individuals need to provide substantial amounts of blood samples to have their blood tested. This is uncomfortable for a large number of people.
Holmes conceived Theranos with the goal of making blood testing simple and more accessible through her supposed novel blood testing technology. Her company aimed to consolidate the different facets of blood testing under a single device.
The Edison and MiniLab Devices
Edison was the first product developed from the proprietary blood testing technology of Theranos. It was marketed as a small device capable of performing a range of immunoassays using a small of blood obtained through a finger prick.
Holmes noted that she took inspiration from famous inventor Thomas Edison while they were developing and naming the device.
The MiniLab was announced in 2016 as an iteration of the Edison. It was larger than its predecessor and was positioned as a diagnostic testing platform that can perform blood tests comparable to full-scale diagnostic laboratories.
Immunoassays are at the heart of these two Theranos devices. These are biochemical tests based on antibody-antigen interactions to detect and measure the presence or concentration of a specific molecule or substance in a sample.
Some of the applications of immunoassays include screening and diagnosis, treatment planning, drug discovery and drug testing, environmental testing, and food safety.
The main selling proposition of the Edison and MiniLab devices was that they can perform a range of immunoassays using a few drops of blood with little to no downtime. Test results would be used to diagnose diseases or screen for particular health conditions.
A “menu” of more than 200 tests was developed by Theranos. The company pitched the capabilities of its devices to pharmaceutical and retail companies.
Retail chain operator Safeway spent USD350 million in 2012 to retrofit its 800 stores into clinics offering Theranos services. Pharmacy store chain Walgreens announced in 2013 that it would be building wellness centers in its stores.
Theranos landed another contract academic medical center Cleveland Clinic in 2015. The partnership aims to test the Theranos devices and use them to cut test costs.
It also became the lab-work provider for AmeriHealth Caritas and Capital BlueCross insurance companies which are based in Pennsylvania in July 2015. It is important to note that the specific MiniLab devices were introduced in 2016.
Emerging Expert and Media Scrutiny
Concerns over the claims of Theranos and the capabilities of their devices emerged. Several reports from patients and doctors surfaced. These involved instances of inaccurate test results and misdiagnoses.
Stanford professor and physician-scientist John Ioannidis wrote an article published in the Journal of the American Medical Association in February 2015. He argued that Theranos had not published peer-reviewed research in the medical research literature.
Canadian biochemist and University of Toronto professor Eleftherios Diamandis also studied the tech. Findings were published in May 2015 in the Clinical Chemistry and Laboratory Medicine. He concluded that most of the claims were exaggerated.
An investigative report by John Carreyrou that was published in The Wall Street Journal in October 2015 drew greater media and public attention.
The Carreyrou article revealed that Theranos was using traditional blood testing machines from other manufacturers to run tests, accommodate testing volumes, and address inaccuracies in results. The Edison devices were not working.
A 2016 inspection by the Center for Medicare and Medicaid Services uncovered irregularities with proficiencies, procedures, and equipment in Theranos lab in Newmark.
Problems with the Theranos Devices
The Edison and MiniLab devices were not working. Theranos and Holmes lied about the purported capabilities of their blood testing tech. It was further revealed that the company manipulated data to fool investors, clients, and the media.
Experts have weighed in about the real problems with the devices. 13 scientists published a study in 2016 that appeared in the Journal of Clinical Investigation. Their findings highlighted several inaccuracies in the blood test results of the company.
These inaccuracies include results outside the normal ranges, significant interservice variability of some lab measurements, and comparative nonequivalence.
Explanations about the abysmal performance of these Theranos devices abound. Some pinned it down to poor calibration and validation. Others noted that these devices are not meant to handle a range of tests at high volumes.
Several studies have also highlighted the unlikelihood of developing a technology that could perform hundreds of tests on a single and small blood sample.
Meaghan M. Bond and Rebecca R. Richards-Kortum studied the drop-top-drop variation in the cellular components of blood drawn from finger-pricking. Their study revealed that the accuracy of finger-prick samples was lower than that of venous blood samples.
It is still possible to perform immunoassays using a small amount of blood. However, in some cases, result accuracy is dependent on different factors.
There are also specific immunoassays and use cases that require larger amounts of blood samples. Some tests need to separate blood components using a centrifuge or require the addition of chemicals. Multiple testing on a single and small sample is impossible.
Some observers also highlighted the inherent problem with Theranos and Holmes. The company was marketing a technology that was nonexistent for at least a decade.
The disastrous leadership and toxic culture
inside the company have also been mentioned often whenever discussions about the problems with its Edison and MiniLab devices surface. Holmes ran an organization headed toward a natural downfall.
Developments were delayed due to the lack of collaboration because departments and teams were siloed in their respective areas.
There is a strong culture of secrecy across different teams and departments. A member of a particular team is not allowed to communicate outside his or her silo. Communication processes were constricted and processes were too bureaucratic.
Nevertheless, regardless of the specific reasons why the Edison and MiniLab devices failed, the fact remains that Theranos never had the required capabilities.
FURTHER READINGS AND REFERENCES
- Bond, M. M. and Richards-Kortum, R. R. 2015. “Drop-to-Drop Variation in the Cellular Components of Fingerprick Blood.” American Journal of Clinical Pathology. 144(6): 885-894. DOI: 1309/ajcp1l7dkmpchpeh
- Carreyrou, J. 2018. Bad Blood: Secrets and Lies in a Silicon Valley Startup. Penguin Random House. ISBN: 9781524731656
- Carreyrou, J. 2015. “Hot Startup Theranos Has Struggled With Its Blood-Test Technology.” The Wall Street Journal. Available online
- Diamandis, E. P. 2015. “Theranos Phenomenon: Promises and Fallacies: Clinical Chemistry and Laboratory Medicine. 53(7): DOI: 1515/cclm-2015-0356
- Ioannidis, J. 2015. “Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?” JAMA: Journal of the American Medical Association. 313(7): 663. DOI: 1001/jama.2014.17662
- Kidd, B. A., Hoffman, G., Zimmerman, N., Li, L., Morgan, J. W., Glowe, P. K., Botwin, G. J., Parekh, S., Babic, N., Doust, M. W., Stock, G. B., Schadt, E. E., and Dudley, J. T. 2016. “Evaluation of Direct-to-Consumer Low-Volume Lab Tests in Healthy Adults.” Journal of Clinical Investigation. 126(5): 1734-1744. DOI: 1172/jci86318