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Mark ở vũ trụ khác · Another Universe Anatomy of a Business Failure #2 · Healthcare · Startups

Theranos

? ~12 / 200+

Theranos, Inc. · 2003–2018 · Palo Alto, California

The promisehundreds of tests from a few drops of fingerstick blood
The realityits own analyzer ran about 12 of more than 200 tests
The enddissolved in Sept 2018; the founder went to prison for defrauding investors
Main sourcesSEC complaint (Mar 2018), CMS inspection report (2016), US v. Holmes court record

Source: SEC press release 2018-41 and complaint SEC v. Holmes (14 Mar 2018); Theranos letter to shareholders (Sept 2018); US v. Holmes verdict (3 Jan 2022).

Re-read in 1 minute

Essence

A promise too goodA few drops from a fingertip, hundreds of tests, cheap and fast.
About 12 of 200+That is all its own analyzer ran. The rest ran on other makers' machines.
$100 million became $100,0002014 revenue projected at over $100 million. Actual: about $100,000.
"Immediate jeopardy"The regulator CMS found the lab threatened patients' health.
Nobody could say "it doesn't work yet"Lab staff saw the problems early. Bad news had to take a detour outside.

Source: complaint SEC v. Holmes (14 Mar 2018): about 12 of more than 200 tests, 2014 projection and revenue; CMS letter of 25 Jan 2016: "immediate jeopardy"; whistleblowers: trial testimony as reported by the press (secondary source).

Part 1

The question

A company raised more than $700 million, had a board full of famous names, and a big pharmacy chain as a partner. Why did nobody check the machine before believing in it? The answer is not "bad luck". A demo was treated as a product, and nobody was allowed to say "it doesn't work yet".

Source: SEC press release 2018-41 (more than $700 million); Walgreens partnership: Walgreens v. Theranos court filing (Nov 2016) as reported by the press.

2003–2013The promiseOne drop of blood, hundreds of tests. Funded on demos and trade secrets.
→
2013–2015Real patientsBlood drawn in pharmacies. Most of it run on other makers' machines.
→
2015–2022CheckedThe press, CMS, FDA, SEC, then the courts. The company dissolved.
Part 2

What happened

Very high on promises, very fast down once someone checked.

An illustrative line of expectations about Theranos, 2003 to 2022. 2003: founded. 2013: launch in Walgreens pharmacies. 2014: peak, Forbes estimated a valuation of about 9 billion dollars. October 2015: first Wall Street Journal article. 2016: CMS finds immediate jeopardy and revokes certification. 2018: SEC charges, company dissolves. 2022: sentencing. 2003founded 2013Walgreens 2014 · ~$9 billion Oct 2015 · WSJ 2016 · CMS"immediate jeopardy" 2018SEC, dissolved 2022sentences
The curve illustrates expectations, not data. The $9 billion valuation is a Forbes estimate based on a funding-round price, not a verified value.Source: valuation: Forbes 2014 (secondary source); WSJ 15 Oct 2015 (secondary source); CMS letter 25 Jan 2016; SEC press release 2018-41; Theranos letter to shareholders Sept 2018; Holmes sentencing 18 Nov 2022.
2003 · FoundedElizabeth Holmes, 19, leaves Stanford to start the company, first named Real-Time Cures. (secondary source)
Sept 2013 · On the shelf at WalgreensFirst blood-draw site in Palo Alto, then about 40 sites, mostly in Arizona. Real patients start receiving results. (secondary source)
2013–2015 · More than $700 millionRaised on claims about its own analyzer, military contracts and revenue. The SEC later found these claims false.
July 2015 · FDA clears one testA fingerstick test for herpes virus HSV-1. One test, not the whole system.
15 Oct 2015 · The first articleWall Street Journal: by the end of 2014 only 15 of more than 240 tests ran on the Edison device, according to a former employee. (secondary source)
25 Jan 2016 · CMS: "immediate jeopardy"After inspecting the Newark lab (Sept–Nov 2015): 5 serious violations; hematology put patients at risk.
May 2016 · Results voidedTheranos told CMS it had voided all Edison results from 2014 and 2015 and sent corrected reports to doctors. (WSJ, secondary source)
7 July 2016 · Certification revokedCMS revokes the lab's certificate and bans Holmes from owning or operating a lab for at least 2 years.
Nov 2016 · A partner turnsWalgreens sues for $140 million. Settled in 2017, amount not disclosed. (secondary source)
14 Mar 2018 · SEC: "massive fraud"Holmes settles: $500,000 penalty, returns 18.9 million shares, gives up control, 10-year bar from leading a public company.
June 2018 · Criminal indictmentHolmes and Balwani (former president and COO) charged with 2 counts of conspiracy and 9 counts of wire fraud.
Sept 2018 · Dissolution"Cash is not nearly sufficient to pay all creditors", so shareholders get nothing.
2022 · SentencesHolmes: guilty on 4 counts of defrauding investors, 135 months. Balwani: guilty on all 12 counts, 155 months. $452 million restitution. Upheld on appeal (24 Feb 2025).

Source: SEC press release 2018-41; FDA clearance of the HSV-1 test (2 July 2015, via Fortune); CMS letter 25 Jan 2016 and sanctions notice 7 July 2016; US v. Holmes indictment (June 2018); CEO David Taylor's letter to shareholders (Sept 2018); verdicts 3 Jan 2022 and 7 July 2022; sentencing 18 Nov 2022 and Dec 2022; Ninth Circuit (24 Feb 2025). Milestones marked "secondary source" come from the press.

Part 1

What happened

one drop of blood$700 million12 of 200dissolved
Part 2

Why

demo as productbad news blockednobody checkedmyths
Part 3

Work lesson

verify the democount, don't listensomeone may say "not yet"
Part 3

Why: four layers of causes

Strategy: selling a product when you only have a demo

demo sold as productSEC complaint
The published menu had more than 200 tests. Theranos's own analyzer performed only about 12. Most of the rest ran on commercial analyzers made by others, some modified for small samples. published menu: more than 200 tests ~12 on its own analyzer the rest: other makers' commercial analyzers, some modified for small samples investors heard: "our machine" reality: mostly someone else's
A demo was sold as a finished product. Theranos put real patients' blood into the system when its own technology handled only a small part. The WSJ gave a similar figure from a different source in 2015: 15 of more than 240.Source: complaint SEC v. Holmes (14 Mar 2018), quoted by NBC News: "approximately 12 tests of the over 200"; SEC press release 2018-41 (modified commercial analyzers); WSJ 15 Oct 2015 (secondary source).

People: what investors heard, and the facts

misrepresentationSEC, 2022 verdicts
What investors heardWhat the record shows
The technology was used on the battlefield in Afghanistan and on medevac helicoptersNever deployed by the US Department of Defense (SEC)
2014 revenue over $100 millionAbout $100,000 (SEC)
Its own analyzer ran the whole menuAbout 12 of more than 200 (SEC)
Validation reports carried big pharma logosHolmes admitted in court she added the logos herself (secondary)

Source: complaint SEC v. Holmes (14 Mar 2018), via STAT, BioCentury, NBC; Holmes's trial testimony (Nov 2021) as reported by the press (secondary source). The jury convicted Holmes on 4 counts of defrauding investors (3 Jan 2022).

Organization: bad news existed but could not travel up

bad news blockedCMS-2567, testimony
Three levels. The lab: in October 2014, 29 percent of quality control checks on Edison devices fell outside the acceptable range. Management: bad news stops here. Investors and partners: hear the promise. Whistleblowers had to go around, to the New York State health department, CMS and the press. the labOct 2014: 29% of Edison QC checks failed management investors, partners: hear the promise ✗ stops the detour outside · New York State health dept. · CMS (complaint) · a WSJ reporter
The errors were not hidden from the people doing the work. The lab itself recorded the failed quality checks. What was missing was a path for that news to travel up without the messenger being treated as a traitor. According to testimony, those who spoke up had to go to outside agencies.Source: CMS Form CMS-2567 for the Newark lab (released Mar–Apr 2016): 29% of Edison QC checks in Oct 2014 outside the acceptable range; testimony of Erika Cheung (Sept 2021) and Tyler Shultz's account as reported by the press (secondary source).

Outside checks: who actually verified?

due diligence gapCMS, FDA, SEC
Those who believed without checking the machine themselves: investors, the pharmacy partner, the board. Those who checked and found the truth: a WSJ reporter in 2015, the FDA in 2015, CMS in 2015 to 2016, the SEC in 2018 and the courts in 2022. believed, did not check investors pharmacy partner board of directors checked, and found out WSJ · Oct 2015 FDA · 2015 CMS · 2015–2016 SEC · 2018 courts · 2022: investors defrauded
"Trade secrets" took the place of data. Those who put money and reputation into Theranos did not insist on seeing the machine run on real samples against a reference method. Those who did insist found the problems within months. According to many press accounts, the board at the time had many former officials but very few laboratory experts.Source: FDA Form 483 after the Aug–Sept 2015 inspection (the "nanotainer" collection tube as an uncleared device, via Fierce Biotech); CMS letter 25 Jan 2016; SEC press release 2018-41; verdict 3 Jan 2022. Board composition: Carreyrou, Bad Blood (2018) (secondary source).

Not "just one person"

Balwani, who ran day-to-day operations, was convicted on all 12 counts, including defrauding patients.

Patients as the test

From 1 Apr to 23 Sept 2015, results of a blood-clotting test went to 81 patients despite quality-control problems (CMS-2567).

Lawyers instead of answers

According to Bad Blood, the company used lawyers to pressure whistleblowers and the newspaper (secondary source).

Source: Balwani verdict (7 July 2022); CMS-2567 for the Newark lab, via BioSpace and TechCrunch (25 Apr 2016); Carreyrou, Bad Blood (2018) (secondary source).

Part 4

Fact check: what is true and what is myth

14 things often said about Theranos, checked against SEC, CMS and court records. Tap each row for the reason.

Outcome of the two trials. Holmes: guilty on 4 counts, all involving investors; not guilty on 4 counts involving patients; jury deadlocked on 3 counts. Balwani: guilty on all 12 counts, including those involving patients. Holmes · 3 Jan 2022 · 11 counts 4 guilty (investors)4 not guilty (patients)3 deadlocked Balwani · 7 July 2022 · 12 counts 12 guilty (investors and patients)
Same company, two different outcomes. The Holmes jury did not convict her on the patient fraud charges. The Balwani jury did convict him. Saying "Holmes defrauded patients" is legally wrong.Source: verdicts in US v. Holmes (3 Jan 2022) and US v. Balwani (7 July 2022), via NPR and TechCrunch; sentencing 18 Nov 2022 (135 months) and Dec 2022 (155 months).
Two conflicting figures on the scale of voided results. In May 2016 Theranos said it had voided all Edison results from 2014 and 2015 and issued tens of thousands of corrected reports. Weeks later, Theranos said fewer than 1 percent of results had been voided or corrected. May 2016 · told CMS (via WSJ)all Edison results 2014–2015 voidedtens of thousands of corrected reports weeks later · Theranos"less than 1%" of results voided or corrected the two figures use different denominators; this article picks neither
Where sources disagree. The first figure covers only Edison results over two years; the second covers all results the company ever returned. At trial, the former lab director testified he voided every Edison result from 2014–2015.Source: WSJ and TechCrunch (18 May 2016), Fierce Biotech (June 2016); Kingshuk Das's trial testimony as reported by the press. All secondary sources.
SOLIDTheranos raised more than $700 million

SEC press release 2018-41 (14 Mar 2018): Holmes, Balwani and Theranos "raised more than $700 million from investors" through false statements.

SOLID2014 revenue was projected at over $100 million; actual about $100,000

SEC complaint, via STAT and BioCentury. A MedCity piece gives the projection as $108 million; wording varies but the gap is a factor of about a thousand.

SOLIDCMS found the lab put patients in "immediate jeopardy"

CMS letter of 25 Jan 2016: 5 condition-level deficiencies; hematology was "immediate jeopardy".

SOLIDHolmes was banned from owning or operating a lab for 2 years

CMS sanctions notice of 7 July 2016, together with revocation of the Newark lab's CLIA certificate.

SOLIDTheranos voided all Edison results from 2014 and 2015

Theranos told CMS (May 2016, via WSJ); former lab director Kingshuk Das testified he voided every Edison result from those two years. The scale is disputed: see the figure above (secondary source).

CAUTION"Theranos was worth $9 billion"

That is a Forbes estimate (2014) based on a funding-round price, meaning what investors were willing to pay for a promise. On dissolution in 2018, shareholders received nothing (CEO Taylor's letter).

CAUTION"One newspaper article brought Theranos down"

The WSJ article of 15 Oct 2015 was the spark. But the binding findings came from bodies with the power to inspect: FDA (2015), CMS (2016), SEC (2018) and the courts (2022).

CAUTION"Theranos was FDA approved"

The FDA cleared only one herpes test, HSV-1 (2 July 2015). The same year the FDA recorded the "nanotainer" collection tube as an uncleared medical device (Form 483).

CAUTION"Holmes got 11 years"

Sentenced to 135 months (11 years 3 months) on 18 Nov 2022. In March 2026 the court took 1 year off under amended sentencing guidelines for first-time offenders (Bloomberg Law, secondary source). Reported release dates differ, so this article gives none.

FALSE"Every startup hypes; Theranos was just unlucky"

Optimism about the future is different from false statements about the present. The SEC found the claims about military contracts, revenue and the analyzer's capabilities false; juries convicted Holmes on 4 counts of defrauding investors and Balwani on 12. There is no "bad luck" in the record.

FALSE"One drop of blood, more than 200 tests on a Theranos machine"

SEC complaint: its own analyzer ran only about 12 of more than 200 tests on the menu. Most ran on other makers' commercial analyzers.

FALSE"Holmes was convicted of defrauding patients"

The jury acquitted Holmes on the 4 patient-related counts (3 Jan 2022). She was convicted on 4 investor-related counts. Balwani, however, was convicted on the patient counts too.

FALSE"Nobody warned anyone"

The lab's own quality-control records logged the failures (CMS-2567: 29% of Edison QC checks failed in Oct 2014). Employees reported to the New York State health department and CMS (testimony, secondary source).

FALSE"Pfizer validated Theranos's technology"

Holmes admitted at trial (Nov 2021) that she added the Pfizer and Schering-Plough logos to reports sent to Walgreens and investors; she said "I wish I had done it differently" (as reported by the press, secondary source).

Source: SEC press release 2018-41 and complaint SEC v. Holmes; CMS letter 25 Jan 2016, CMS-2567, sanctions notice 7 July 2016; FDA (July 2015, Form 483); verdicts 3 Jan 2022 and 7 July 2022; sentencing 18 Nov 2022; Theranos letter to shareholders Sept 2018. Rows marked "secondary source" come from the press.

Part 5

Verdict

Scores are Mark's assessment based on the sources in Part 8, not data from a study.

Avoidable
5/5
Warning signs beforehand
5/5
Public, transparent record
4/5
Lessons retained
3/5
What the system got right
  • Regulators inspected on site and published the record
  • The press held the story despite pressure
  • Courts tried the case, appeals upheld it, restitution ordered
What went wrong
  • Investors and partners accepted promises in place of data
  • Real patients became the test
  • SEC settled without admission; Walgreens settlement terms undisclosed

Not bad luck. A demo was sold as a product, and the people who knew the truth had no way to say "it doesn't work yet".

More: the line between "vision" and "false statement"

Every startup sells the future. The difference is the tense. "We will run 200 tests" is a risky promise. "Our machine runs 200 tests" describes the present, and can be checked.

Theranos fell over sentences in the present tense: the machine works, the military uses it, the revenue is there. The lesson for ordinary work: when you report, separate "done", "in testing" and "planned". When you hear a report, ask which tense it is in.

Source for "More": the claims come from the complaint SEC v. Holmes (14 Mar 2018); the rest is Mark's commentary.

Part 6

Work lesson: verify before you believe the demo

Works for any demo: software, AI models, prototypes, a colleague's or vendor's "it's done" report.

Four habits: ask what the demo runs on; count instead of listening; have someone allowed to say not yet; secrecy is not evidence, let an outsider check. 1 · runs on what?real samples, real machinevs. the standard method 2 · count, don't listen"how many of 200?"the answer is a number 3 · who says "not yet"named, protectedbad news goes straight up 4 · an outsider checkssecret ≠ evidencesign an NDA, then show A demo that ran once is not a product that runs every day.
Each habit patches one failure at Theranos. A demo treated as a product, "200 tests" nobody counted, bad news blocked, and "secrecy" in place of data.Source: the failures come from the complaint SEC v. Holmes, the CMS letter of 25 Jan 2016 and CMS-2567; the habits are Mark's suggestions.
Watch the demo on your dataBring your own real samples, not the ones they prepared. Compare with the old method on the same samples.
Turn questions into numbers"Does it work well?" becomes "how many out of the total, and how many failures last month?"
Give someone the right to say "not yet"Name one person on the team who may stop a launch on seeing a failure, and nobody is punished for bad news.
Secrecy does not exempt from checksIf someone refuses to let an outsider look even under an NDA, treat it as a signal, not a reason.
Check your own team: 5 questions
  1. The last time someone said "this doesn't work yet", what happened to them?
  2. Did the last demo you saw run on real data or on prepared data?
  3. Has anyone outside the team checked the results by hand?
  4. How long does bad news from the front line take to reach the decision-maker?
  5. Can the number you promised your client or boss be counted today, or is it still "will"?
Optimism about the future is a founder's job. False statements about the present are not.Mark's summary of the SEC record and the US v. Holmes verdict, not a quotation.
Part 7

Read next

SEC v. Holmes and Theranos, complaint (14 Mar 2018)The primary document listing each false statement to investors next to the facts.
CMS, Statement of Deficiencies for the Newark lab (2016)A 121-page inspection record. Read it to see the errors logged inside the lab itself.
John Carreyrou, Bad Blood (2018) (secondary source)The book by the reporter behind the WSJ series, told from the employees' and whistleblowers' side.
Anatomy of a Business Failure #3: NokiaWhen bad news cannot reach the top, leaders go blind.
Part 8

Primary sources

Regulators', courts' and the company's own documents first. Note: while this article was made, sec.gov, justice.gov and cms.gov could not be reached directly; the content of the primary documents below was cross-checked through several press reports that quote them. Open the originals to add paragraph numbers before reuse.

  1. SEC, press release 2018-41, "Theranos, CEO Holmes, and Former President Balwani Charged With Massive Fraud", 14 Mar 2018. sec.gov
  2. SEC, SEC v. Elizabeth Holmes and Theranos, Inc., complaint, N.D. Cal., No. 5:18-cv-01602, 14 Mar 2018; Litigation Release LR-24069. sec.gov
  3. CMS, letter to Theranos of 25 Jan 2016 (5 condition-level deficiencies, "immediate jeopardy"); Form CMS-2567 for the Newark lab (released 2016); notice of proposed sanctions 18 Mar 2016; sanctions notice 7 July 2016. The proposed-sanctions notice is transcribed at Wikisource.
  4. FDA, clearance of the Theranos HSV-1 IgG test (2 July 2015) and two Forms 483 (2015), via Fortune and Fierce Biotech.
  5. US v. Holmes and Balwani, N.D. Cal., No. 5:18-cr-00258: indictment June 2018; Holmes verdict 3 Jan 2022, Balwani verdict 7 July 2022; sentencing 18 Nov 2022 and Dec 2022; $452 million restitution order. Via NPR, ABC7, TechCrunch.
  6. Ninth Circuit Court of Appeals, United States v. Holmes and United States v. Balwani, 24 Feb 2025, via Bloomberg Law and Law360.
  7. Theranos, CEO David Taylor's letter to shareholders on dissolution, Sept 2018, via NPR and Engadget.
  8. (secondary source) John Carreyrou, "Hot Startup Theranos Has Struggled With Its Blood-Test Technology", Wall Street Journal, 15 Oct 2015; and Bad Blood (2018).
  9. (secondary source) Forbes (2014, June 2016) on valuation; TechCrunch 18 May 2016 and Fierce Biotech on voided results; BioSpace, TechCrunch 25 Apr 2016 on CMS-2567; 2021 trial coverage (testimony of Holmes, Cheung, Das); Bloomberg Law Mar 2026 on the sentence reduction.