Theranos notified approximately 176,000 patients in 2016 that their Edison-generated test results from 2014–2015 were being voided because the company could no longer stand behind their accuracy. Some of those patients had made clinical decisions based on those results.

Elizabeth Holmes was convicted in January 2022 on four counts of wire fraud against investors and sentenced to 11 years and 3 months in federal prison. The conviction followed a full jury trial with extensive documentary and whistleblower evidence.

Ramesh Balwani was convicted in July 2022 on all 12 counts, including wire fraud against both investors and patients. His sentence of nearly 13 years exceeded Holmes's, reflecting the jury's finding of broader culpability.

The Centers for Medicare and Medicaid Services inspected Theranos's Newark laboratory in 2015–2016, found it posed immediate jeopardy to patient health, and revoked its CLIA laboratory certification. Holmes was personally banned from operating a laboratory for two years.

Internal documents and testimony showed the Edison could reliably perform only a small fraction of the tests Theranos advertised. For most of its menu, Theranos used conventional third-party laboratory equipment — Siemens and others — while presenting results as Edison-derived.

Former Theranos employees Tyler Shultz (grandson of board member George Shultz) and Erika Cheung provided detailed whistleblower testimony and documentation to regulators and journalists. Their accounts are corroborated by internal documents produced in litigation.

Theranos employed its general counsel and outside law firm to threaten former employees with litigation for breach of non-disclosure agreements. The suppression of internal dissent delayed public exposure of the fraud by months or years.

Theranos's board included former Secretaries of State George Shultz and Henry Kissinger, former Secretary of Defense James Mattis, and other prominent figures who provided reputational cover but had no relevant scientific or medical expertise. Their presence does not exculpate Holmes but illustrates how institutional credibility was leveraged.

Documents entered at Holmes' federal trial showed Theranos's own internal quality control data revealed Edison device results for HIV, HbA1c, and sodium tests routinely fell outside acceptable accuracy ranges. The company suppressed this data while publicly claiming FDA-comparable precision.

Two separate Theranos employees, Tyler Shultz (grandson of board member George Shultz) and Erika Cheung, independently contacted the CMS and Wall Street Journal with consistent accounts of altered quality controls, manipulated test samples, and threatened employees. Their corroborating testimony was central to the criminal case.

Theranos notified approximately 176,000 patients in 2016 that their Edison-generated test results from 2014–2015 were being voided because the company could no longer stand behind their accuracy. Some of those patients had made clinical decisions based on those results.

Elizabeth Holmes was convicted in January 2022 on four counts of wire fraud against investors and sentenced to 11 years and 3 months in federal prison. The conviction followed a full jury trial with extensive documentary and whistleblower evidence.

Ramesh Balwani was convicted in July 2022 on all 12 counts, including wire fraud against both investors and patients. His sentence of nearly 13 years exceeded Holmes's, reflecting the jury's finding of broader culpability.

The Centers for Medicare and Medicaid Services inspected Theranos's Newark laboratory in 2015–2016, found it posed immediate jeopardy to patient health, and revoked its CLIA laboratory certification. Holmes was personally banned from operating a laboratory for two years.

Internal documents and testimony showed the Edison could reliably perform only a small fraction of the tests Theranos advertised. For most of its menu, Theranos used conventional third-party laboratory equipment — Siemens and others — while presenting results as Edison-derived.

Former Theranos employees Tyler Shultz (grandson of board member George Shultz) and Erika Cheung provided detailed whistleblower testimony and documentation to regulators and journalists. Their accounts are corroborated by internal documents produced in litigation.

Theranos employed its general counsel and outside law firm to threaten former employees with litigation for breach of non-disclosure agreements. The suppression of internal dissent delayed public exposure of the fraud by months or years.

Documents entered at Holmes' federal trial showed Theranos's own internal quality control data revealed Edison device results for HIV, HbA1c, and sodium tests routinely fell outside acceptable accuracy ranges. The company suppressed this data while publicly claiming FDA-comparable precision.

Two separate Theranos employees, Tyler Shultz (grandson of board member George Shultz) and Erika Cheung, independently contacted the CMS and Wall Street Journal with consistent accounts of altered quality controls, manipulated test samples, and threatened employees. Their corroborating testimony was central to the criminal case.

Theranos's board included former Secretaries of State George Shultz and Henry Kissinger, former Secretary of Defense James Mattis, and other prominent figures who provided reputational cover but had no relevant scientific or medical expertise. Their presence does not exculpate Holmes but illustrates how institutional credibility was leveraged.

Holmes' defence at trial maintained she was a true believer who made optimistic projections in good faith and was partly misled by laboratory director Ramesh Balwani. The jury acquitted her on four charges related to investor fraud and charges involving patients, suggesting some evidence for genuine rather than purely cynical deception.

Holmes was acquitted on four of eleven counts, including all charges related to patient fraud, and convicted only on investor-fraud counts. The jury's split verdict suggests the evidence supported a more bounded conspiracy than the "wholesale patient endangerment by design" framing in popular accounts. This does not mitigate the harm to patients who received inaccurate results, but it means attributing to Holmes a fully coordinated conspiracy to endanger patients specifically — rather than to defraud investors — overstates what the trial record established.

Theranos's proprietary "Edison" devices, while demonstrably incapable of the broad testing menu the company claimed, did produce clinically valid results for a narrow range of assays — notably certain finger-stick tests for influenza antigens. CMS inspection reports and trial evidence distinguished between tests run on Theranos proprietary hardware (unreliable for most analytes) and tests the company ran on modified third-party Siemens and other commercial analyzers (more reliable). The company's fraud was in representing proprietary technology as universally validated when it was not, and in using third-party equipment while claiming proprietary results. This is criminal fraud, but it coexisted with partial genuine technical capability, complicating all-or-nothing "fake technology" characterizations.

Major Theranos investors — including Rupert Murdoch, the DeVos family, and Walgreens — failed to conduct standard scientific due diligence before committing hundreds of millions of dollars. Standard venture-practice peer review of Theranos's technology claims was not performed, partly because Holmes leveraged board prestige and NDAs to prevent it. This investor failure does not diminish Holmes's criminal culpability, which courts affirmed, but it raises questions about why sophisticated investors accepted claims without verification. The fraud narrative is accurate; however, the additional framing of Theranos as an elaborate conspiracy that fooled rigorous scrutiny is inaccurate — scrutiny was largely absent by choice of the investors involved.

Theranos's FDA submission for a herpes simplex virus-1 test received clearance in 2015, and internal documents show some influenza and other assays performed within acceptable ranges on standard Siemens and other third-party analyzers Theranos used. The core fraud involved claiming proprietary Edison device capability that did not exist, not that zero tests worked. Distinguishing between the categories of test performance — some assays functional, many not, Edison platform uniformly inadequate — matters for understanding the specific fraud rather than treating the technology as entirely fictional from inception.

Theranos's investor base included Rupert Murdoch, Betsy DeVos, and the Walton family — sophisticated principals who invested without requiring standard venture due diligence, including independent technical validation or audited financials. Holmes's ability to maintain deception partly depended on investors' willingness to accept secrecy as a sign of competitive sensitivity rather than a red flag. The criminal fraud finding rightly rests on Holmes's misrepresentations; the scale of capital raised reflects a failure of investor discipline that was self-inflicted, not solely Holmes's creation. Both are true simultaneously.

Theranos's miniLab platform showed genuine developmental promise for a small subset of tests — particularly herpes simplex and influenza immunoassays using modified Siemens ADVIA platforms. FDA cleared one Theranos test (Zika virus, 2016) under emergency use. This partial technical validity does not excuse the fraudulent clinical claims but complicates a narrative of pure invention-from-nothing. Investor and partner due-diligence failures — Walgreens sent no clinical staff to evaluate the technology — are separable from Holmes's criminal fraud culpability.

Independent analysis, including reporting from the AACC and some former Theranos scientists, acknowledged that the company's conventional laboratory analyzers — as opposed to the Edison devices — produced results within normal accuracy ranges for a subset of standard tests. The fraud centered on misrepresenting the Edison device's capabilities and using conventional Siemens analyzers while claiming proprietary nano-technology. The distinction matters: investor deception about which technology was producing results is different from every test result being fabricated.

Theranos's board included former secretaries of state, defense secretaries, and senior military figures — sophisticated parties with access to technical advisors. The failure of these investors to demand independent validation of the technology before committing capital reflects a due-diligence failure on their part, not solely Holmes's deception. The criminal conviction addressed Holmes's specific misrepresentations to investors and patients, not a broader finding that all losses were solely attributable to fraud rather than investor negligence.