Research summary
Research summary
Topic summary
Elizabeth Holmes, Theranos, and the claims that built and then broke the blood-testing story.
Key research questions
- Voided and Inaccurate Test Results
- Data Manipulation and Quality Control Issues
- False Patient Results and Harm
- Sample Dilution Practices
- Siemens Machine Issues
- Ian Gibbons' Suicide
- CMS Findings and Sanctions
- Use of Commercial Analyzers
Important claims and supporting citations
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.
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.
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.
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.
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.
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.
Theranos purchased commercial Siemens ADVIA analyzers through a secret subsidiary to avoid suspicion from Siemens because their own technology failed.
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.
Competing explanations
Theranos voided all Edison results from 2014 and 2015 and issued tens of thousands of corrected reports.
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.
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.
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.
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."
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.
Outstanding questions
- The miniLab, introduced in 2016 to replace the Edison, was essentially a robotic glue gun paired with mini test tubes.
- Theranos voided all Edison results from 2014 and 2015 and issued tens of thousands of corrected reports.
- Elizabeth Holmes personally admitted under oath to altering documents by adding Pfizer and Schering-Plough logos to Theranos-authored reports.
- 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.
- More than 10% of Theranos' test results given to Arizonans between 2013 and 2016 were ultimately voided or corrected.
- Internal documents and whistleblower testimonies indicated data manipulation to hide inaccuracies in Theranos' test results.
- The miniLab's miniaturized centrifuge was known to occasionally explode.
- Erika Cheung reported that Theranos supervisors instructed staff to delete or disregard outlier quality control data points to make runs pass.
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Elizabeth Holmes personally admitted under oath to altering documents by adding Pfizer and Schering-Plough lo…
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.
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…
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–…
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…
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
Voided and Inaccurate Test Results
Labels: Inferred, Low, known
Data Manipulation and Quality Control Issues
Data Manipulation and Quality Control Issues
Labels: Inferred, Low, known
False Patient Results and Harm
False Patient Results and Harm
Labels: Inferred, Low, known
Sample Dilution Practices
Sample Dilution Practices
Labels: Inferred, Low, known
Siemens Machine Issues
Siemens Machine Issues
Labels: Inferred, Low, investigate
Ian Gibbons' Suicide
Ian Gibbons' Suicide
Labels: Inferred, Low, investigate
CMS Findings and Sanctions
CMS Findings and Sanctions
Labels: Inferred, Low, useful
Use of Commercial Analyzers
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…
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.
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…
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.
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…
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…
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…
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.
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…
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…
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…
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.
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.
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…
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…
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…
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.
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…
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…
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…
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: Source-linked, High, known
Holmes described the Pfizer-logo report as Pfizer’s “own technical validation” when emailing it to Walgreens.
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.
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…
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…
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…
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…
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.
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…
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…
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…
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.
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.
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…
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.
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…
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.
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…
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…
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…
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…
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.
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…
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…
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…
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…
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.
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.
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…
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…
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…
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…
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…
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.
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…
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…
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…
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.
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.
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…
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…
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…
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…
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.
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.
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…
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…
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…
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…
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…
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.
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…
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…
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…
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…
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…
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),…
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…
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…
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.
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…
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…
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.
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…
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.
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…
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…
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.
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…
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…
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…
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…
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.
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…
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.
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…
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…
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…
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.
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…
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…
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…
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…
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…
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…
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…
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.
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.
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…
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…
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