# Theranos: 123 Sourced Claims, Contested Facts & Evidence

Elizabeth Holmes, Theranos, and the claims that built and then broke the blood-testing story.

Authors: david
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### Elizabeth Holmes personally admitted under oath to altering documents by adding Pfizer and Schering-Plough lo…

Id: claim_1535c3f6c840c0f8045fedaf
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Elizabeth Holmes personally admitted under oath to altering documents by adding Pfizer and Schering-Plough logos to Theranos-authored reports.

Labels: Inferred, High, investigate

### The miniLab's miniaturized centrifuge was known to occasionally explode.

Id: claim_1c0d942fcc00ec114ea70a95
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

The miniLab's miniaturized centrifuge was known to occasionally explode.

Labels: Inferred, High, investigate

### Theranos generated no revenue in 2012 or 2013, while recording net losses of approximately $57 million in 201…

Id: claim_8f0fec28b9911cb235a6bccc
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Theranos generated no revenue in 2012 or 2013, while recording net losses of approximately $57 million in 2012 and $92 million in 2013, according to testimony from corporate controller Han Spivey.

Labels: Source-linked, High

### Theranos's Edison machines could reliably perform only a very small number of tests, reportedly as few as 12–…

Id: claim_932a5ae546fa61874ad5a3e6
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

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, known

### The miniLab, introduced in 2016 to replace the Edison, was essentially a robotic glue gun paired with mini te…

Id: claim_94d91c839e0493a861fb1554
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

The miniLab, introduced in 2016 to replace the Edison, was essentially a robotic glue gun paired with mini test tubes.

Labels: Source-linked, Medium, investigate

### Voided and Inaccurate Test Results

Id: section_06ad113228e2b3a277ca6b03
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Voided and Inaccurate Test Results

Labels: Inferred, Low, known

### Data Manipulation and Quality Control Issues

Id: section_0bc15611e50587b36a9e9f61
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Data Manipulation and Quality Control Issues

Labels: Inferred, Low, known

### False Patient Results and Harm

Id: section_19e47c2eaf50be16697b476a
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

False Patient Results and Harm

Labels: Inferred, Low, known

### Sample Dilution Practices

Id: section_1f4b69b0cb4b4f87c3d2b99e
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Sample Dilution Practices

Labels: Inferred, Low, known

### Siemens Machine Issues

Id: section_47c95e56b289e85fcad85a00
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Siemens Machine Issues

Labels: Inferred, Low, investigate

### Ian Gibbons' Suicide

Id: section_6c692eba097b7ed20dba7294
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Ian Gibbons' Suicide

Labels: Inferred, Low, investigate

### CMS Findings and Sanctions

Id: section_9d7bb4d2884a49e8b6d41a77
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

CMS Findings and Sanctions

Labels: Inferred, Low, useful

### Use of Commercial Analyzers

Id: section_b4b911643f1a69d5a33cde1f
Parent: topic_1lzLpJtlzgWZxR5z2o6h
Depth: 1

Use of Commercial Analyzers

Labels: Inferred, Low, investigate

#### Theranos reported $1,944,948.00 in total income to the IRS for 2015, despite investor-facing materials projec…

Id: claim_02c37fc14498bf04ba877001
Parent: claim_8f0fec28b9911cb235a6bccc
Depth: 2

Theranos reported $1,944,948.00 in total income to the IRS for 2015, despite investor-facing materials projecting significantly greater financial performance, including a $230 million profit projection.

Labels: Inferred, High

#### Pfizer paid Theranos approximately $900,000 for a ~15-month exploratory cancer-patient study.

Id: claim_0961e9936e9f3376a3bb4c36
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Pfizer paid Theranos approximately $900,000 for a ~15-month exploratory cancer-patient study.

Labels: Inferred, Medium

#### Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Sie…

Id: claim_17d7915376642154072cf847
Parent: section_b4b911643f1a69d5a33cde1f
Depth: 2

Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Siemens because their own technology failed.

Labels: Source-linked, High, known

#### Shane Weber first learned of the doctored Pfizer-logo version of the report at trial.

Id: claim_21ff9e1215f7037ca871c7b0
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Shane Weber first learned of the doctored Pfizer-logo version of the report at trial.

Labels: Inferred, Medium

#### On December 29, 2023, the HHS Inspector General excluded Elizabeth Holmes from participation in all federal h…

Id: claim_2440c7c648d12eba0d49f0f1
Parent: section_9d7bb4d2884a49e8b6d41a77
Depth: 2

On December 29, 2023, the HHS Inspector General excluded Elizabeth Holmes from participation in all federal health-care programs for 90 years. An administrative law judge upheld this exclusion on April 25, 2025, and the HHS Departmental Appeals Board subsequently affirmed it in 2026.

Labels: Source-linked, High

#### Internal documents and whistleblower testimony confirmed that Theranos's test results were frequently inaccur…

Id: claim_351e870d9b6c23eb7e835b14
Parent: section_06ad113228e2b3a277ca6b03
Depth: 2

Internal documents and whistleblower testimony confirmed that Theranos's test results were frequently inaccurate.

Labels: Inferred, High, investigate

#### Theranos operated two separate lab systems: one for demonstrations to investors/partners using the Edison dev…

Id: claim_35da9b783e495cdb2643d7d7
Parent: section_b4b911643f1a69d5a33cde1f
Depth: 2

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: Source-linked, High, known

#### Internal documents and whistleblower testimonies indicated frequent quality control failures at Theranos.

Id: claim_4af7550280acb922d3177e28
Parent: section_0bc15611e50587b36a9e9f61
Depth: 2

Internal documents and whistleblower testimonies indicated frequent quality control failures at Theranos.

Labels: Inferred, High, known

#### Holmes stated she added the logos because the work was done in partnership with those companies and she was t…

Id: claim_59261dcc3b3adc79902ac748
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Holmes stated she added the logos because the work was done in partnership with those companies and she was trying to convey that.

Labels: Inferred, Medium

#### Holmes expressed regret, stating "I wish I had done it differently," after learning during trial testimony th…

Id: claim_603c40830656629b8cc2f093
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Holmes expressed regret, stating "I wish I had done it differently," after learning during trial testimony that investors and partners perceived the logos as endorsements.

Labels: Inferred, Medium

#### Sunny Balwani ordered lab staff to run federal proficiency testing samples exclusively on third-party commerc…

Id: claim_663edaacd49cff96b9928dad
Parent: section_b4b911643f1a69d5a33cde1f
Depth: 2

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: Source-linked, High, known

#### CMS cited Theranos for "immediate jeopardy" due to its lab practices.

Id: claim_66edbf0533cac28819b7f255
Parent: section_9d7bb4d2884a49e8b6d41a77
Depth: 2

CMS cited Theranos for "immediate jeopardy" due to its lab practices.

Labels: Inferred, High, known

#### Pfizer scientist Shane Weber reviewed Theranos's cancer-patient study in 2008–2009.

Id: claim_6bee8987f0b6ba2684cc0e94
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Pfizer scientist Shane Weber reviewed Theranos's cancer-patient study in 2008–2009.

Labels: Inferred, Medium

#### Elizabeth Holmes admitted under oath on November 23, 2021, during her criminal fraud trial in San Jose, that…

Id: claim_6f6cb1c73f3d2ad6b3c71cca
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Elizabeth Holmes admitted under oath on November 23, 2021, during her criminal fraud trial in San Jose, that she personally added Pfizer and Schering-Plough logos to Theranos-authored reports.

Labels: Inferred, High

#### In November 2013, Ramesh "Sunny" Balwani informed Elizabeth Holmes that Theranos had approximately $15 millio…

Id: claim_6fac6de234fce0225570ddc0
Parent: claim_8f0fec28b9911cb235a6bccc
Depth: 2

In November 2013, Ramesh "Sunny" Balwani informed Elizabeth Holmes that Theranos had approximately $15 million in cash and was spending as much as $2 million weekly, indicating roughly 7.5 weeks of cash at the maximum reported burn rate.

Labels: Inferred, High

#### More than 10% of Theranos' test results given to Arizonans between 2013 and 2016 were ultimately voided or co…

Id: claim_7409726ef23a34e88ca02d0b
Parent: section_06ad113228e2b3a277ca6b03
Depth: 2

More than 10% of Theranos' test results given to Arizonans between 2013 and 2016 were ultimately voided or corrected.

Labels: Inferred, High, investigate

#### The Pfizer-logo report sent to Walgreens was a near-identical copy of Theranos’s earlier cancer-patient study.

Id: claim_7b5c3048d66b2286b4c9985e
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

The Pfizer-logo report sent to Walgreens was a near-identical copy of Theranos’s earlier cancer-patient study.

Labels: Inferred, Medium

#### Holmes emailed the Pfizer-logo report to Walgreens in April 2010 with the subject “Pfizer Theranos System Val…

Id: claim_8559826e2fba041079dcd336
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Holmes emailed the Pfizer-logo report to Walgreens in April 2010 with the subject “Pfizer Theranos System Validation Final Report.”

Labels: Inferred, Medium

#### The appellate record indicates that Elizabeth Holmes admitted to placing GlaxoSmithKline’s logo on a report w…

Id: claim_9284fe46e55a303780962967
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

The appellate record indicates that Elizabeth Holmes admitted to placing GlaxoSmithKline’s logo on a report with favorable conclusions about Theranos technology, despite pharmaceutical-company representatives testifying that their companies had not independently validated the technology nor authorized logo use.

Labels: Inferred, High

#### Insiders revealed that Theranos often used traditional machines from other manufacturers for many tests, desp…

Id: claim_95f9fa70c6d47d04cad1e6d9
Parent: section_b4b911643f1a69d5a33cde1f
Depth: 2

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…

Id: claim_9accfb3180ae0e1132898ef8
Parent: section_b4b911643f1a69d5a33cde1f
Depth: 2

Safeway executives ignored constant missed deadlines and the fact that Theranos covertly ran Safeway employee blood tests on standard Siemens machines.

Labels: Source-linked, High, known

#### Holmes described the Pfizer-logo report as Pfizer’s “own technical validation” when emailing it to Walgreens.

Id: claim_b8b96a6f3ec5a346963d6357
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Holmes described the Pfizer-logo report as Pfizer’s “own technical validation” when emailing it to Walgreens.

Labels: Inferred, Medium

#### The Pfizer logo was placed on every page of the doctored Theranos report.

Id: claim_bd4c55f1d0c8885d9b40eff0
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

The Pfizer logo was placed on every page of the doctored Theranos report.

Labels: Inferred, Medium

#### Ian Gibbons, a biochemist involved in early patents, was a chief scientist at Theranos and died by suicide in…

Id: claim_c67b5039485567664ef674c0
Parent: section_6c692eba097b7ed20dba7294
Depth: 2

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, known

#### Theranos often diluted finger-prick samples to run on equipment designed for venous blood, which introduced s…

Id: claim_c9b1d93be3a9546553707911
Parent: section_1f4b69b0cb4b4f87c3d2b99e
Depth: 2

Theranos often diluted finger-prick samples to run on equipment designed for venous blood, which introduced significant error.

Labels: Inferred, Medium, known

#### Shane Weber found the nine conclusions of Theranos's cancer-patient study "not believable" and advised Pfizer…

Id: claim_ccf715260c64e3a7b48057eb
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Shane Weber found the nine conclusions of Theranos's cancer-patient study "not believable" and advised Pfizer against any partnership with Theranos.

Labels: Inferred, High

#### Some Theranos patients received false positives for HIV, cancer, and other conditions, or false negatives tha…

Id: claim_e2205bb126485cacdd9114d8
Parent: section_19e47c2eaf50be16697b476a
Depth: 2

Some Theranos patients received false positives for HIV, cancer, and other conditions, or false negatives that delayed treatment.

Labels: Inferred, High, useful

#### Holmes denied intending to create the impression that the pharmaceutical companies authored the reports.

Id: claim_e6bfd6a3a1c064a1c4c5a1f9
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Holmes denied intending to create the impression that the pharmaceutical companies authored the reports.

Labels: Inferred, Medium

#### CMS found Theranos failed to comply with at least five CLIA condition-level requirements in January 2016, inc…

Id: claim_f3a1569a6f2c54953746cb45
Parent: section_9d7bb4d2884a49e8b6d41a77
Depth: 2

CMS found Theranos failed to comply with at least five CLIA condition-level requirements in January 2016, including hematology testing, analytic systems, lab director qualification, testing personnel, and technical supervision.

Labels: Inferred, High, known

#### Data problems at Theranos were not confined to the Edison machines; commercial Siemens instruments also faile…

Id: claim_fa95a06b3099840574ef8b46
Parent: section_47c95e56b289e85fcad85a00
Depth: 2

Data problems at Theranos were not confined to the Edison machines; commercial Siemens instruments also failed proficiency testing and were misconfigured.

Labels: Inferred, High, known

#### Shane Weber testified that no Pfizer employee authorized the Pfizer logo or the claims of “superior performan…

Id: claim_fe2d7abb0cc8c0c55e599f95
Parent: claim_1535c3f6c840c0f8045fedaf
Depth: 2

Shane Weber testified that no Pfizer employee authorized the Pfizer logo or the claims of “superior performance” and “excellent” accuracy in the Theranos report.

Labels: Inferred, High

##### Theranos agreed to the Arizona Consent Decree to provide full restitution and avoid further litigation.

Id: claim_0666c16c7a36d9e58e8f57e4
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos agreed to the Arizona Consent Decree to provide full restitution and avoid further litigation.

Labels: Inferred, Medium

##### Theranos voided all Edison results from 2014 and 2015 and issued tens of thousands of corrected reports.

Id: claim_0f2a3f13d522603965079470
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos voided all Edison results from 2014 and 2015 and issued tens of thousands of corrected reports.

Labels: Contested, High, investigate

##### A Walgreens representative testified that the planned rollout of Theranos services was reduced partly because…

Id: claim_0f98171f5373b3371b8cd3dd
Parent: claim_9accfb3180ae0e1132898ef8
Depth: 3

A Walgreens representative testified that the planned rollout of Theranos services was reduced partly because a high proportion of collections required venipuncture rather than finger sticks.

Labels: Source-linked, High

##### Some Theranos patients received false negatives that delayed treatment.

Id: claim_1d617c86b2eb0a60825a66a9
Parent: claim_e2205bb126485cacdd9114d8
Depth: 3

Some Theranos patients received false negatives that delayed treatment.

Labels: Inferred, High, investigate

##### Prosecutors characterized Theranos's burn rate as a range of $1 million to $2 million per week "at certain po…

Id: claim_26071e9bfb7738fec8b1d737
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

Prosecutors characterized Theranos's burn rate as a range of $1 million to $2 million per week "at certain points," not a fixed $2 million maximum.

Labels: Inferred, High

##### Ian Gibbons, Theranos's Chief Scientist, died by suicide in May 2013.

Id: claim_29fbe3478b099718ddd24228
Parent: claim_c67b5039485567664ef674c0
Depth: 3

Ian Gibbons, Theranos's Chief Scientist, died by suicide in May 2013.

Labels: Inferred, High, investigate

##### Approximately 834,233 (exactly 10.6%) of the 7,862,146 test results provided by Theranos to Arizona consumers…

Id: claim_2a61c02ff7be4d38e9975d42
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Approximately 834,233 (exactly 10.6%) of the 7,862,146 test results provided by Theranos to Arizona consumers between 2013 and 2016 were ultimately voided or corrected.

Labels: Inferred, High

##### Erika Cheung reported that Theranos supervisors instructed staff to delete or disregard outlier quality contr…

Id: claim_2ba96b48bab0be7114fcc0fa
Parent: claim_4af7550280acb922d3177e28
Depth: 3

Erika Cheung reported that Theranos supervisors instructed staff to delete or disregard outlier quality control data points to make runs pass.

Labels: Inferred, High, investigate

##### Theranos claimed its company-wide voiding/correction of less than 1% of results was done "out of an abundance…

Id: claim_2d66e3e52d9edff52db3abbe
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos claimed its company-wide voiding/correction of less than 1% of results was done "out of an abundance of caution" and that it stood behind the other 99% with no plans for further corrections.

Labels: Contested, High

##### Trial evidence showed that during VIP demonstrations, an Edison or miniLab device sometimes ran a "null proto…

Id: claim_2ebc18107a2f494afb071315
Parent: claim_35da9b783e495cdb2643d7d7
Depth: 3

Trial evidence showed that during VIP demonstrations, an Edison or miniLab device sometimes ran a "null protocol" that did not test the sample, while some VIP samples were secretly tested on third-party instruments.

Labels: Inferred, High

##### Most Walgreens wellness centers that partnered with Theranos were located in Arizona.

Id: claim_2f1699161204e496b7d46a17
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Most Walgreens wellness centers that partnered with Theranos were located in Arizona.

Labels: Inferred, Medium

##### If $6.9 million is the correct 2013 cash trough, the implied runway at $2 million/week is approximately 3.5 w…

Id: claim_374da01eba317b1d6f4f3cb5
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

If $6.9 million is the correct 2013 cash trough, the implied runway at $2 million/week is approximately 3.5 weeks, which is roughly half the 7.5 weeks stated in the parent claim.

Labels: Contested, High

##### Each ordered "blood test" (panel or service) from Theranos typically generated multiple individual assay/resu…

Id: claim_3dd82e25b7ce55dc5691cc69
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Each ordered "blood test" (panel or service) from Theranos typically generated multiple individual assay/results, with an average of approximately 5.1 results per test order in the Arizona data.

Labels: Inferred, High

##### The restitution amount of $4,652,000 in the Arizona Consent Decree equaled the total amounts paid by Arizona…

Id: claim_3e81d687586f4f2714f49f84
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

The restitution amount of $4,652,000 in the Arizona Consent Decree equaled the total amounts paid by Arizona consumers for Theranos tests.

Labels: Inferred, High

##### Neither Elizabeth Holmes nor the Inspector General requested an evidentiary hearing, so the ALJ ruled on a pa…

Id: claim_4fc70efdbf7e54ddfbf8ea61
Parent: claim_2440c7c648d12eba0d49f0f1
Depth: 3

Neither Elizabeth Holmes nor the Inspector General requested an evidentiary hearing, so the ALJ ruled on a paper record.

Labels: Inferred, Medium

##### For the majority of tests, Theranos secretly used third-party Siemens analyzers and other commercial machines.

Id: claim_5d13351545e59f76bf738d93
Parent: claim_95f9fa70c6d47d04cad1e6d9
Depth: 3

For the majority of tests, Theranos secretly used third-party Siemens analyzers and other commercial machines.

Labels: Inferred, High, known

##### The derived "7.5 weeks of runway" in the parent claim is an arithmetic inference, not a documented statement.

Id: claim_69429dac55d430d55505dd8a
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

The derived "7.5 weeks of runway" in the parent claim is an arithmetic inference, not a documented statement.

Labels: Inferred, Low

##### Theranos entered master purchase agreements with both Walgreens and Safeway in 2010, with the primary objecti…

Id: claim_6ac98b60d572a79bae269de5
Parent: claim_9accfb3180ae0e1132898ef8
Depth: 3

Theranos entered master purchase agreements with both Walgreens and Safeway in 2010, with the primary objective of introducing an in-store blood-testing service nationwide.

Labels: Source-linked, Medium

##### Theranos programmed a Siemens machine in Arizona to the wrong settings and it failed several tests gauging th…

Id: claim_74dbd64d69c5e969d733c7a8
Parent: claim_fa95a06b3099840574ef8b46
Depth: 3

Theranos programmed a Siemens machine in Arizona to the wrong settings and it failed several tests gauging the purity of water used in the machine.

Labels: Inferred, High, known

##### Theranos's $92 million net loss in 2013 is arithmetically consistent with a burn rate of approximately $1.77…

Id: claim_786b631834a909a471855e17
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

Theranos's $92 million net loss in 2013 is arithmetically consistent with a burn rate of approximately $1.77 million/week, which is slightly below the $2 million headline figure.

Labels: Inferred, High

##### Theranos diluted tiny finger-prick samples to meet volume requirements for commercial analyzers, which lowere…

Id: claim_9e73de8f84ee059eedb610da
Parent: claim_c9b1d93be3a9546553707911
Depth: 3

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, known

##### Theranos paid $25,000 for attorneys’ fees and claims-administrator costs as part of the Arizona Consent Decre…

Id: claim_ab7395423dc149a681c5ed95
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos paid $25,000 for attorneys’ fees and claims-administrator costs as part of the Arizona Consent Decree.

Labels: Inferred, High

##### The blood tests sold by Theranos to Arizona consumers between 2013 and 2016 yielded 7,862,146 test results.

Id: claim_ace8ed57832731a5812f63c9
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

The blood tests sold by Theranos to Arizona consumers between 2013 and 2016 yielded 7,862,146 test results.

Labels: Inferred, High

##### A CMS sanctions letter noted that four out of five of Theranos' troponin values for the second 2014 proficien…

Id: claim_af0cdc7be7b2973467b2bd9a
Parent: claim_fa95a06b3099840574ef8b46
Depth: 3

A CMS sanctions letter noted that four out of five of Theranos' troponin values for the second 2014 proficiency testing event were unacceptable when reviewed against "All Participants" values, and no peer data was available for the Siemens Immulite 2000.

Labels: Inferred, High, known

##### Theranos's corporate controller, Yam/Spivey, testified that the company made no revenue in 2012 and 2013 and…

Id: claim_b0d0889eb11c2a6232b738b8
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

Theranos's corporate controller, Yam/Spivey, testified that the company made no revenue in 2012 and 2013 and was burning through $2 million per week in 2013, leading to cash getting "a bit tight."

Labels: Contested, High

##### The "approximately $15 million in cash" figure and the specific "November 2013 Balwani-to-Holmes" attribution…

Id: claim_b2a22efcf5b2bd7822d4910d
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

The "approximately $15 million in cash" figure and the specific "November 2013 Balwani-to-Holmes" attribution in the parent claim are not confirmed by public sources.

Labels: Inferred, High

##### Some Theranos patients received false positives for HIV, cancer, and other conditions.

Id: claim_b5b0d9add760a0f2d3b7130d
Parent: claim_e2205bb126485cacdd9114d8
Depth: 3

Some Theranos patients received false positives for HIV, cancer, and other conditions.

Labels: Inferred, High, investigate

##### Theranos paid $200,000 in civil penalties as part of the Arizona Consent Decree.

Id: claim_c26ee1fa6eb329688566ec60
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos paid $200,000 in civil penalties as part of the Arizona Consent Decree.

Labels: Inferred, High

##### HHS rejected Elizabeth Holmes's argument that her acquittal on patient-related counts precluded exclusion for…

Id: claim_c44780fecac606230b15a6ea
Parent: claim_2440c7c648d12eba0d49f0f1
Depth: 3

HHS rejected Elizabeth Holmes's argument that her acquittal on patient-related counts precluded exclusion for an offense connected with health-care delivery, holding that investor fraud concerning Theranos’s blood-testing products and services had a "common sense connection or nexus" to health-care delivery.

Labels: Source-linked, High

##### In June 2016, Theranos informed Walgreens that 31,000 test reports provided to Walgreens customers had been v…

Id: claim_d0f9686e99c46bc68ac57c1f
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

In June 2016, Theranos informed Walgreens that 31,000 test reports provided to Walgreens customers had been voided, representing 11.3% of total Walgreens customers who used the service.

Labels: Inferred, High

##### Prosecutors told the Balwani jury that Theranos was down to $6.9 million in cash in 2013, which is less than…

Id: claim_d1ba52356484880a0dfc330d
Parent: claim_6fac6de234fce0225570ddc0
Depth: 3

Prosecutors told the Balwani jury that Theranos was down to $6.9 million in cash in 2013, which is less than half the ~$15 million asserted in the parent claim.

Labels: Contested, High

##### Theranos agreed not to own, operate, or direct any CLIA lab in Arizona for two years from March 28, 2017, as…

Id: claim_d1ee7d517cb088a15ba75550
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos agreed not to own, operate, or direct any CLIA lab in Arizona for two years from March 28, 2017, as part of the Arizona Consent Decree.

Labels: Inferred, High

##### The CMS found significant deficiencies in Theranos' Newark California lab in 2015.

Id: claim_d85e7db42e8859b4d08e1a8d
Parent: claim_66edbf0533cac28819b7f255
Depth: 3

The CMS found significant deficiencies in Theranos' Newark California lab in 2015.

Labels: Inferred, High, known

##### Between 2013 and 2016, Theranos sold approximately 1,545,339 blood tests to about 175,940 Arizona consumers.

Id: claim_deec4fe0b27d678715a634ca
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Between 2013 and 2016, Theranos sold approximately 1,545,339 blood tests to about 175,940 Arizona consumers.

Labels: Inferred, High, investigate

##### By December 2014, Elizabeth Holmes was discussing a model where Theranos would merely rent space in Walgreens…

Id: claim_e35d9bb147448b0058592feb
Parent: claim_9accfb3180ae0e1132898ef8
Depth: 3

By December 2014, Elizabeth Holmes was discussing a model where Theranos would merely rent space in Walgreens stores, even as investors were being told to expect expansion to hundreds of stores in 2015.

Labels: Source-linked, High

##### Elizabeth Holmes told a Theranos director by June 2014 that she was considering terminating the Safeway relat…

Id: claim_e719455924a74d82ba1093e0
Parent: claim_9accfb3180ae0e1132898ef8
Depth: 3

Elizabeth Holmes told a Theranos director by June 2014 that she was considering terminating the Safeway relationship, and by August 2014, Theranos and Safeway had ceased communicating, yet Holmes continued discussing the relationship with investors that fall.

Labels: Inferred, High

##### Theranos did not admit liability or the state’s allegations of misrepresentations/omissions about methodology…

Id: claim_ec23cedc87f1a7aa830e2f60
Parent: claim_7409726ef23a34e88ca02d0b
Depth: 3

Theranos did not admit liability or the state’s allegations of misrepresentations/omissions about methodology, accuracy, reliability, purpose, or lack of informed consent.

Labels: Inferred, Medium

##### Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos…

Id: claim_f814ed4d625244a3680e53c0
Parent: claim_351e870d9b6c23eb7e835b14
Depth: 3

Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos' test results.

Labels: Inferred, High, investigate

##### Theranos implemented an internal "outlier deletion" practice, which involved discarding up to two out of six…

Id: claim_faa2e00ab456a0ac615436e7
Parent: claim_4af7550280acb922d3177e28
Depth: 3

Theranos implemented an internal "outlier deletion" practice, which involved discarding up to two out of six data points in a quality-control run to ensure a passing result.

Labels: Inferred, High, investigate

###### Dr.

Id: claim_08f27b64f0f30273eb6605ba
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Dr. Mark Pandori's letter provides institutional backing for inferring that some patients necessarily received falsely reassuring (false-negative) results, even without named patient cases.

Labels: Inferred, High

###### The claim that "Some Theranos patients received false negatives that delayed treatment" is weakly supported b…

Id: claim_09a65753cb3f4a5114c9ea26
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

The claim that "Some Theranos patients received false negatives that delayed treatment" is weakly supported but under-specified by public sources.

Labels: Inferred, Medium

###### A 2012 amendment to the Walgreens contract stipulated that Theranos would establish a training and certificat…

Id: claim_0f1d759e664b85d195277a7a
Parent: claim_6ac98b60d572a79bae269de5
Depth: 4

A 2012 amendment to the Walgreens contract stipulated that Theranos would establish a training and certification program for Walgreens technicians to provide laboratory patient services under Theranos’s direction, with Theranos supplying collection tubes, lancets/finger-stick devices, bandages, and related materials.

Labels: Source-linked, High

###### Support for the "false negative / delayed treatment" aspect of Theranos errors comes mainly from regulator fi…

Id: claim_16402c5eb476cfb86111f1ec
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Support for the "false negative / delayed treatment" aspect of Theranos errors comes mainly from regulator findings of systemic inaccuracy and victim-impact filings, rather than numerous named, verifiable patient stories.

Labels: Inferred, Medium

###### The practice of removing outliers at Theranos contributed to the eventual voiding of tens of thousands of tes…

Id: claim_1894252dae247987b9aeed7e
Parent: claim_2ba96b48bab0be7114fcc0fa
Depth: 4

The practice of removing outliers at Theranos contributed to the eventual voiding of tens of thousands of test results.

Labels: Inferred, High

###### Arizona's figure of 834,233 voided or corrected results encompasses the broader testing operation and should…

Id: claim_213ccc6221c61c2e2fd85ed8
Parent: claim_0f2a3f13d522603965079470
Depth: 4

Arizona's figure of 834,233 voided or corrected results encompasses the broader testing operation and should not be confused with the Edison-only total.

Labels: Inferred, High

###### For patients with false-negative-type errors (e.g., a falsely normal result that had forestalled follow-up),…

Id: claim_2171458c2dc36f381b710ae4
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

For patients with false-negative-type errors (e.g., a falsely normal result that had forestalled follow-up), Theranos's remediation process of issuing void notices left the diagnostic gap unclosed.

Labels: Inferred, High

###### The underlying review found instances where Edison patient results had been released after failed or unaccept…

Id: claim_2779e336ae598848d8325d3d
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The underlying review found instances where Edison patient results had been released after failed or unacceptable quality control.

Labels: Inferred, High

###### Later evidence indicates that approximately 50,000 to 60,000 individual Edison test results were voided by Th…

Id: claim_2c800203adb31ad8a46bfb5b
Parent: claim_0f2a3f13d522603965079470
Depth: 4

Later evidence indicates that approximately 50,000 to 60,000 individual Edison test results were voided by Theranos, not necessarily 50,000 to 60,000 patients or laboratory reports.

Labels: Inferred, High, investigate

###### The government's sentencing filings in U.S.

Id: claim_3a71173056c529581d153e47
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

The government's sentencing filings in U.S. v. Holmes (November 2022) included patient victim-impact statements describing delayed diagnoses and treatment following inaccurate Theranos results.

Labels: Inferred, High

###### The terms "50,000–60,000 tests," "reports," and "patients" are not interchangeable units when discussing Ther…

Id: claim_3b2843d0fdbe1f4fdd09829d
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The terms "50,000–60,000 tests," "reports," and "patients" are not interchangeable units when discussing Theranos's voided results.

Labels: Inferred, High

###### Erika Cheung's actions as a whistleblower highlighted ethical issues within Theranos and emphasized the impor…

Id: claim_3dbd57cb6dd85747fa88205a
Parent: claim_2ba96b48bab0be7114fcc0fa
Depth: 4

Erika Cheung's actions as a whistleblower highlighted ethical issues within Theranos and emphasized the importance of whistleblower protections in exposing corporate malpractice.

Labels: Inferred, High

###### Dr.

Id: claim_48708117b2704dae4b3273d4
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Dr. Mark Pandori's November 2015 resignation letter as Theranos lab director stated he could not assure the reliability of results issued during his tenure.

Labels: Inferred, High

###### Erroneous INR results for patients on warfarin could lead to undetected over- or under-anticoagulation, repre…

Id: claim_5360802a3197174f1c0666e3
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Erroneous INR results for patients on warfarin could lead to undetected over- or under-anticoagulation, representing a failure to flag a dangerous condition.

Labels: Inferred, High

###### The Edison quality control problems were not limited to a single assay or an isolated instrument event.

Id: claim_5c09d9c9ac2013b9774d1bca
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The Edison quality control problems were not limited to a single assay or an isolated instrument event.

Labels: Inferred, High

###### CMS material reviewed at trial identified problematic Edison quality-control records for assays including vit…

Id: claim_5eeb23549ac3965c2d202376
Parent: claim_0f2a3f13d522603965079470
Depth: 4

CMS material reviewed at trial identified problematic Edison quality-control records for assays including vitamin B12, vitamin D, and sex-hormone-binding globulin.

Labels: Inferred, High

###### Most of the best-documented individual patient cases in the public record concerning Theranos errors are fals…

Id: claim_629ab6c59d6cd09066d3922d
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Most of the best-documented individual patient cases in the public record concerning Theranos errors are false positives, such as those related to cancer, HIV, or miscarriage scares.

Labels: Inferred, Medium

###### Theranos's voiding decision followed a review broader than just the CMS inspection sample.

Id: claim_657fe1b6db0da4256dfb70e5
Parent: claim_0f2a3f13d522603965079470
Depth: 4

Theranos's voiding decision followed a review broader than just the CMS inspection sample.

Labels: Inferred, High

###### When Theranos voided approximately 50,000–60,000 Edison results in 2016, the "corrected reports" were void no…

Id: claim_65e420844e29597d2dc08e1c
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

When Theranos voided approximately 50,000–60,000 Edison results in 2016, the "corrected reports" were void notices, not replacement values.

Labels: Inferred, High

###### Outside testing confirmed Brittany Gould had a healthy pregnancy, and she subsequently delivered a healthy ba…

Id: claim_762bd1cbc14d83b152e480ea
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Outside testing confirmed Brittany Gould had a healthy pregnancy, and she subsequently delivered a healthy baby.

Labels: Inferred, High

###### Brittany Gould's hCG results from Theranos falsely indicated her pregnancy was failing or miscarrying, leadin…

Id: claim_790161409357ad7e44919b9e
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Brittany Gould's hCG results from Theranos falsely indicated her pregnancy was failing or miscarrying, leading to counseling that she should consider ending the pregnancy.

Labels: Inferred, High

###### The broader remediation of "tens of thousands of corrected reports" included results from non-Edison testing…

Id: claim_87817a17756c55607b5b7f18
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The broader remediation of "tens of thousands of corrected reports" included results from non-Edison testing and apparently involved both Theranos laboratories.

Labels: Inferred, High

###### The court in U.S.

Id: claim_8c63442abd7696c7dee9f8f1
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

The court in U.S. v. Holmes did not publicly quantify how many victim-impact statements involved false negatives versus false positives.

Labels: Inferred, Medium

###### One category of quality control failure involved a “10X warning,” where ten successive QC results fell on the…

Id: claim_8d9a88716da82a48e84bc144
Parent: claim_0f2a3f13d522603965079470
Depth: 4

One category of quality control failure involved a “10X warning,” where ten successive QC results fell on the same side of the expected mean, yet Theranos continued to issue patient results.

Labels: Inferred, High

###### Brittany Gould, an Arizona medical assistant, underwent multiple Theranos blood draws in 2014.

Id: claim_9072710a13cc110fbfad16f6
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Brittany Gould, an Arizona medical assistant, underwent multiple Theranos blood draws in 2014.

Labels: Inferred, High

###### Theranos reported a total of 31,000 voided or corrected tests, which is materially lower than the 50,000–60,0…

Id: claim_a02e54a406316510ab6e448a
Parent: claim_0f2a3f13d522603965079470
Depth: 4

Theranos reported a total of 31,000 voided or corrected tests, which is materially lower than the 50,000–60,000 estimate later provided by Das.

Labels: Contested, High, useful

###### Erika Cheung's testimony revealed systematic data manipulation at Theranos, which involved removing up to two…

Id: claim_a2b3aeadbd0b1971b41d8499
Parent: claim_2ba96b48bab0be7114fcc0fa
Depth: 4

Erika Cheung's testimony revealed systematic data manipulation at Theranos, which involved removing up to two out of six data points from quality-control runs.

Labels: Source-linked, High

###### The removal of outliers at Theranos led to the release of inaccurate test results, as tests that would have f…

Id: claim_a4e72728f9924e60f6cb0f1c
Parent: claim_2ba96b48bab0be7114fcc0fa
Depth: 4

The removal of outliers at Theranos led to the release of inaccurate test results, as tests that would have failed quality control checks were reported as passing.

Labels: Inferred, High

###### CMS's January 2016 survey of the Theranos Newark lab cited condition-level deficiencies in hematology.

Id: claim_aa51a53b074f485c852262eb
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

CMS's January 2016 survey of the Theranos Newark lab cited condition-level deficiencies in hematology.

Labels: Inferred, High

###### For Edison results, the "corrected reports" issued by Theranos were generally void notices, not replacement n…

Id: claim_ae015e79691426bed04c2ca9
Parent: claim_0f2a3f13d522603965079470
Depth: 4

For Edison results, the "corrected reports" issued by Theranos were generally void notices, not replacement numerical results.

Labels: Inferred, High, useful

###### The Theranos-Safeway master purchase agreement represented Theranos as both a "health care provider" and a HI…

Id: claim_b3911826c3fb728340cce830
Parent: claim_6ac98b60d572a79bae269de5
Depth: 4

The Theranos-Safeway master purchase agreement represented Theranos as both a "health care provider" and a HIPAA "covered entity."

Labels: Inferred, High

###### Brittany Gould's case is documented in the Holmes trial victim submissions and reported coverage of the trial…

Id: claim_b66ff196950cd160b80d1573
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Brittany Gould's case is documented in the Holmes trial victim submissions and reported coverage of the trial's patient witnesses.

Labels: Inferred, Medium

###### The original claim regarding Theranos voiding Edison results and issuing corrected reports is substantially c…

Id: claim_c36a8d6e869a0ee99538b140
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The original claim regarding Theranos voiding Edison results and issuing corrected reports is substantially confirmed.

Labels: Inferred, High, investigate

###### CMS findings, supported by whistleblower accounts, were crucial in the regulatory crackdown on Theranos, lead…

Id: claim_d5b42a130b2987c0c4bec35a
Parent: claim_2ba96b48bab0be7114fcc0fa
Depth: 4

CMS findings, supported by whistleblower accounts, were crucial in the regulatory crackdown on Theranos, leading to the revocation of its lab license in 2016.

Labels: Inferred, High

###### The available record does not fully reconcile whether the difference between Theranos's 31,000 figure and Das…

Id: claim_d5b929012a40e81930a80669
Parent: claim_0f2a3f13d522603965079470
Depth: 4

The available record does not fully reconcile whether the difference between Theranos's 31,000 figure and Das's 50,000-60,000 estimate arose from counting dates, laboratories, reports versus results, or different remediation categories.

Labels: Inferred, High

###### Theranos investor materials stated that the company could bill major insurers, Medicare, and Medicaid, and Th…

Id: claim_d7dbabb8880d54ef20cc9e82
Parent: claim_6ac98b60d572a79bae269de5
Depth: 4

Theranos investor materials stated that the company could bill major insurers, Medicare, and Medicaid, and Theranos also presented Walgreens with a "Medicaid/Medicare Opportunity" to increase adoption of Theranos systems.

Labels: Source-linked, High

###### Dr.

Id: claim_dfcf7cbd9ef8868c07935aec
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Dr. Mark Pandori's tenure as Theranos lab director covered the period when tens of thousands of results later voided were released.

Labels: Inferred, High

###### Dr.

Id: claim_e4e309415d9855b45ae90402
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

Dr. Mark Pandori's resignation letter was reported by John Carreyrou's Wall Street Journal investigation (October 2015) and in Bad Blood (2018).

Labels: Inferred, Medium

###### The error in Brittany Gould's case risked unnecessary termination of pregnancy, which is a materially distinc…

Id: claim_e732e93f0f828a972661f0e3
Parent: claim_1d617c86b2eb0a60825a66a9
Depth: 4

The error in Brittany Gould's case risked unnecessary termination of pregnancy, which is a materially distinct harm pathway from delayed treatment.

Labels: Inferred, High

###### One Edison device showed vitamin B12 coefficients of variation of 34.3% and 48.5% at two control levels in Ja…

Id: claim_ff8da0984c941e78de94d26d
Parent: claim_0f2a3f13d522603965079470
Depth: 4

One Edison device showed vitamin B12 coefficients of variation of 34.3% and 48.5% at two control levels in January 2015.

Labels: Inferred, High