Research summary
Research summary
Topic summary
Elizabeth Holmes, Theranos, and the claims that built and then broke the blood-testing story.
Key research questions
- Inaccurate Test Results and Quality Failures
- Theranos Device Limitations
- Ian Gibbons' Death
- Use of Commercial Analyzers
- Patient Harm from False Results
Important claims and supporting citations
Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Siemens because their own technology failed.
The miniLab's miniaturized centrifuge was known to occasionally explode.
Some Theranos patients received false negatives that delayed treatment.
Ian Gibbons, Theranos's Chief Scientist, died by suicide in May 2013.
Internal documents and whistleblower testimony confirmed that Theranos's test results were frequently inaccurate.
Theranos operated two separate lab systems: one for demonstrations to investors/partners using the Edison device, and another for actual patient results using commercial analyzers.
Internal documents and whistleblower testimonies indicated frequent quality control failures at Theranos.
For the majority of tests, Theranos secretly used third-party Siemens analyzers and other commercial machines.
Outstanding questions
- Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos' test results.
View all claims (text)
Claims
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The CMS found significant deficiencies in Theranos' Newark, California lab in 2015.
The CMS found significant deficiencies in Theranos' Newark, California lab in 2015.
Labels: Inferred, High
Inaccurate Test Results and Quality Failures
Inaccurate Test Results and Quality Failures
Labels: Inferred, Low
Theranos Device Limitations
Theranos Device Limitations
Labels: Inferred, Low
Ian Gibbons' Death
Ian Gibbons' Death
Labels: Inferred, Low
Use of Commercial Analyzers
Use of Commercial Analyzers
Labels: Inferred, Low
Patient Harm from False Results
Patient Harm from False Results
Labels: Inferred, Low
Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Sie…
Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Siemens because their own technology failed.
Labels: Inferred, High
The miniLab's miniaturized centrifuge was known to occasionally explode.
The miniLab's miniaturized centrifuge was known to occasionally explode.
Labels: Inferred, High
Some Theranos patients received false negatives that delayed treatment.
Some Theranos patients received false negatives that delayed treatment.
Labels: Inferred, High
Ian Gibbons, Theranos's Chief Scientist, died by suicide in May 2013.
Ian Gibbons, Theranos's Chief Scientist, died by suicide in May 2013.
Labels: Inferred, High
Internal documents and whistleblower testimony confirmed that Theranos's test results were frequently inaccur…
Internal documents and whistleblower testimony confirmed that Theranos's test results were frequently inaccurate.
Labels: Inferred, High
Theranos operated two separate lab systems: one for demonstrations to investors/partners using the Edison dev…
Theranos operated two separate lab systems: one for demonstrations to investors/partners using the Edison device, and another for actual patient results using commercial analyzers.
Labels: Inferred, High
Internal documents and whistleblower testimonies indicated frequent quality control failures at Theranos.
Internal documents and whistleblower testimonies indicated frequent quality control failures at Theranos.
Labels: Inferred, High
For the majority of tests, Theranos secretly used third-party Siemens analyzers and other commercial machines.
For the majority of tests, Theranos secretly used third-party Siemens analyzers and other commercial machines.
Labels: Inferred, High
Sunny Balwani ordered lab staff to run federal proficiency testing samples exclusively on third-party commerc…
Sunny Balwani ordered lab staff to run federal proficiency testing samples exclusively on third-party commercial analyzers rather than the Edison to maintain CLIA lab certification.
Labels: Inferred, High
Theranos's Edison machines could reliably perform only a very small number of tests, reportedly as few as 12–…
Theranos's Edison machines could reliably perform only a very small number of tests, reportedly as few as 12–15, out of the more than 240 tests advertised.
Labels: Inferred, High
The miniLab, introduced in 2016 to replace the Edison, was essentially a robotic glue gun paired with mini te…
The miniLab, introduced in 2016 to replace the Edison, was essentially a robotic glue gun paired with mini test tubes.
Labels: Inferred, Medium
Insiders revealed that Theranos often used traditional machines from other manufacturers for many tests, desp…
Insiders revealed that Theranos often used traditional machines from other manufacturers for many tests, despite promoting its "Edison" device.
Labels: Inferred, High, not_relevant
Safeway executives ignored constant missed deadlines and the fact that Theranos covertly ran Safeway employee…
Safeway executives ignored constant missed deadlines and the fact that Theranos covertly ran Safeway employee blood tests on standard Siemens machines.
Labels: Inferred, High
Theranos diluted tiny finger-prick samples to meet volume requirements for commercial analyzers, which lowere…
Theranos diluted tiny finger-prick samples to meet volume requirements for commercial analyzers, which lowered analyte concentrations below reliable ranges and distorted results.
Labels: Inferred, High
Some Theranos patients received false positives for HIV, cancer, and other conditions.
Some Theranos patients received false positives for HIV, cancer, and other conditions.
Labels: Inferred, High
Ian Gibbons, a biochemist involved in early patents, was a chief scientist at Theranos and died by suicide in…
Ian Gibbons, a biochemist involved in early patents, was a chief scientist at Theranos and died by suicide in 2013 amid pressures.
Labels: Inferred, High
Theranos often diluted finger-prick samples to run on equipment designed for venous blood, which introduced s…
Theranos often diluted finger-prick samples to run on equipment designed for venous blood, which introduced significant error.
Labels: Inferred, Medium
Some Theranos patients received false positives for HIV, cancer, and other conditions, or false negatives tha…
Some Theranos patients received false positives for HIV, cancer, and other conditions, or false negatives that delayed treatment.
Labels: Inferred, High
Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos…
Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos' test results.
Labels: Inferred, High, investigate