Startups, Diagnostics

Theranos Doomsday Clock: A full timeline of its rise and fall (Updated)

So much news continues to emerge about Theranos. First it was hype, and now it's notice of decline. So we've compiled a handy — and highly comprehensive — timeline (doomsday clock) of the erstwhile unicorn.

Der Untergang der Titanic

Gotta say it: These days, Theranos is bleeding. The once-hot diagnostics startup has a public image that just continues to flounder in the wake of that damning Wall Street Journal series and now, the company’s story — and the reputation of its core technology — is just riddled with holes. How did it get to this point?

Grand ambitions and just a touch too much showmanship (without the goods to back it up) are the main reasons why the media’s going mad over Theranos’ decline.

Will Theranos bleed out? Time will tell — which is why we’ve assembled a comprehensive timeline (doomsday clock?) of this unicorn’s stealthy rise and meteoric fall. We’ll keep this timeline updated as news continues to emerge about Theranos. Tick tock:

Theranos: THE STEALTH YEARS

Elizabeth Holmes, a chemical engineering major at Stanford University, drops out of college in 2003 with a vision to launch “Real-Time Cures” — the earliest incarnation of the single-drop-of-blood company it has become today:

February 11, 2005: Theranos — still called Real-Time Cures — bags a $5.8 million Series A round, according to a regulatory filing. Tech venture firm Draper Fisher Jurvetson is listed as an early investor.

February 21, 2006: Theranos – so named because it’s an amalgam of “therapeutics” and “diagnostics” — gets another $9.9 million in a Series B round, according to a regulatory filing. ATA Ventures joins DFJ in the investment pool.

June 22, 2006: One of the earliest Holmes profiles is published in Inc. magazine, listed in a “30 under 30” feature. (Mark Zuckerberg, then 22, also made the cut). It describes the startup’s earliest vision, and describes Holmes in a characteristically flattering light:

Many entrepreneurs like to say they’re out to change the world. Holmes is staying true to her promise. At the age of 20, she designed a device with the goal of saving the estimated 100,000 people who die each year from adverse drug reactions.

November 7, 2006: Theranos is already ready for a $28.5 million Series C financing, according to a regulatory filing. Continental Ventures and Tako Ventures are tacked on as investors. In these days, Theranos still claims to rest in the pharmacogenomics space, as Venture Beat said at the time.

August 2007: Theranos files a complaint in Santa Clara, California, Superior Court against three former employees it accused of misappropriating trade secrets, the San Francisco Business Times reports.

March 4, 2009: After three years of stealth, Elizabeth Holmes speaks at Stanford as part of an “entrepreneurial thought leaders” series. In the talk, she says some of the primary areas of interest for Theranos are infectious disease and oncology, and that the company focuses on proteomic analysis.

July 8, 2010: Theranos raises another $45 million in a Series D round, from a single unnamed investor. Investopedia says by this point, Theranos’ valuation already sits at $1 billion.

April 11, 2012: Theranos stealthily opens its Newark, California-based laboratory at the Pacific Research Center. Of the move, the San Francisco Business Times writes: “It is unclear why the identity of the tenant was kept under such tight wraps.” Hmm.

November 30, 2012: Theranos files suit against Fuisz Pharma, accusing it of stealing its patent files from law firm McDermott Will & Emery, and using them to file a rival blood-testing patent, Law360 reports.

Theranos: BIRTH OF A UNICORN

After years of stealthy fundraising and behind-the-curtain tinkering on Edison, Holmes emerges into the spotlight — and the media drools:

August 30, 2013: The San Francisco Business Times writes the first detailed profile of Theranos, in which there’s a telling quote from Holmes: “The company’s culture is such that confidentiality is the essence of its existence.”

September 8, 2013The Wall Street Journal kicks off its coverage of Theranos, and commentator Joe Rago is drinking the Kool-Aid —  referring to the company’s instant diagnosis technology as a “breakthrough.” Rago mentions the company’s infamous nanotainers for the first time, discusses its new partnership with Walgreens, and marvels at the largely non-medical, but star-studded board, that Theranos boasts. And with that, Theranos hurtles to the media spotlight — and the comparisons to Steve Jobs (and references to black turtlenecks) begin.

November 13, 2013: Theranos and Walgreens announce their first Wellness Centers in the Phoenix metropolitan area — marking the company’s first expedition out of California. Over the next two years, it would open 42 such diagnostic centers throughout the state.

February 2014: Real questions start to emerge around the “hows” of Theranos. By this point the company has been profiled — twice — by Wiredtouting the company’s ability to run 30 lab tests with a single drop of blood. However, this is despite the claims the company still hasn’t disclosed how it’s managed such a feat. Its patent list is beginning to show the direction in which its headed; by this point upwards of a dozen are publicly available. Today, there are 63.

April 16, 2014: Former Senate Majority Leader Dr. Bill Frist is added to Theranos’ board. He joins former Secretaries of State Henry Kissinger and George Shultz, former Defense Secretary William Perry, retired Marine Corps Gen. James “Mad Dog” Mattis, retired Navy Adm. Gary Roughead and ex-U.S. Sen. Sam Nunn, the San Francisco Business Times reports.

June 12, 2014: A previously undisclosed amount of private equity funding is invested in Theranos — hurtling its value up to $9 billion, and securing Holmes’ face on the cover of essentially every major publication. Estimates now put the round at either $400 million or, most recently revealed by the Wall Street Journal, a stunning $633 million.

July 22, 2014: Theranos announces it’s leased a 20,000-square-foot space in Phoenix; plans to hire 500.

September 29, 2014: Holmes makes it onto the 2014 Forbes 4oo wealthiest Americans list, given that her net worth is projected at this point to be around $4.5 billion.

December 8, 2014: Holmes makes the New YorkerIt casts a critical eye on the secrecy shrouding Theranos, but marvels at Holmes’ sudden ascent to the spotlight.

March 9, 2015: In a move that somewhat hushes the growing set of Theranos naysayers that fixate on its lack of public validation, the unicorn partners with Cleveland Clinic. The long-term strategic alliance is set up to pursue “the full potential of Theranos technology at Cleveland Clinic and across the broader healthcare system.”

March 14, 2015: Former U.S. Secretary of State George Shultz — a Theranos board member — lets slip that the company is seeking approval from the Food and Drug Administration for an early detection Ebola test, the Silicon Valley Business Journal reports.

May 5, 2015: Theranos announces it’ll add a full-blown reference lab, allowing costlier, more specialized tests in addition to its standard battery of lab testing — touting that it can use “micro-samples” from venous draws to get the same results as diagnostics giants like Quest and Lab Corp.

June 23, 2015: Theranos says it’s bringing its work down to Mexico, partnering with the Carlos Slim Foundation.

July 2, 2015: In what seems like a definitive shushing to critics, Theranos gets clearance from the FDA for its HSV-1 test. This is a milestone moment for the company, as some of its technology is validated by the government — and its so-called trade secrets are made public.

July 8, 2015: Theranos strikes a deal with Capital BlueCross, a Pennsylvania insurer that covers 725,000 individuals. It plans to partner with Capital BlueCross to open new wellness centers on the East Coast.

July 16, 2015: Theranos gets a CLIA waiver from the FDA, allowing it to run its devices outside a laboratory. The company plans to bring its devices to wellness centers as well as physicians offices and hospitals — decentralizing the lab testing process for the company.

August 24, 2015: Cloud-based EHR vendor Practice Fusion — itself in a bit of trouble inks a deal with Theranos, with plans to link providers with Theranos’ lab testing services.

Theranos: IT’S A LONG WAY DOWN

Suddenly in mid-October, everything went to hell for Theranos. The company’s been in pure damage control mode since that famously scathing piece in the Wall Street Journal: 

October 15, 2015: John Carreyrou of the Wall Street Journal publishes his deeply critical piece of Theranos. He speaks with several former employees, and finds that not only is the company mismanaged — but that it’s been overselling the efficacy of Edison. Rather, Carreyrou’s sources say that many of the diagnostics tests are actually run on standard lab equipment – and Theranos simply dilutes the samples so as to use that single drop of blood. Holmes attempts to refute Carreyrou’s piece by making several appearances in the media, saying she was “shocked” by the accusations.

October 16, 2015: Theranos stops collecting blood samples using its proprietary “nanotainers,” thanks to questions from the FDA.

October 20, 2015: Google Ventures’ Bill Maris explains to Business Insider why it didn’t invest in Theranos:

“We looked at it a couple times, but there was so much hand-waving — like, Look over here! — that we couldn’t figure it out,” Maris tells Business Insider. “So, we just had someone from our life-science investment team go into Walgreens and take the test. And it wasn’t that difficult for anyone to determine that things may not be what they seem here.”

October 23, 2015: Walgreens takes a critical look at its deal with Theranos, the Wall Street Journal reports. The pharmacy chain halts any plans to open up new Wellness Centers as it probes the validity of Theranos’ technology.

October 27, 2015: The FDA releases Theranos inspection reports that are critical of its nanotainer and Edison technology.

October 28, 2015: Fortune reports that Theranos had planned to raise another $200 million in a Series C-3 funding round just a few days before Carreyrou’s first article in the Wall Street Journal.

November 10, 2015: Theranos’ potential $350 million deal with Safeway grocery stores fizzles out, the Wall Street Journal reports. Safeway had built clinics in some 800 stores, but never began using Theranos’ tests.

November 30, 2015: News emerges that Theranos had clashed with Arizona lab inspectors, calling into question the efficacy of its Walgreens Wellness Centers in the state.

December 3, 2015: In a surprising dose of damage control, Holmes says Theranos is conducting more tests than ever before.

December 20, 2015: A former Theranos lab employee filed a complaint with CMS in September, saying its machines had “major stability, precision and accuracy problems.” The Wall Street Journal reports that two federal investigations are underway over concerns about  accuracy, protocol.

December 28, 2015: News from the Wall Street Journal emerges that in advance of a $633 million fundraise, a Theranos lab was inspected by CMS. However, inspectors didn’t even test Theranos’ single-blood-drop machinery, but instead looked at tests that had been run using standard lab equipment.

January 24, 2016: U.S. health inspectors find serious deficiencies at Theranos’ Newark, California, laboratories, the Wall Street Journal reports. This CMS audit could put Theranos at risk of suspension from the Medicare program.

January 25, 2016: CMS says that Theranos shows substandard blood testing practices that “pose immediate jeopardy to patient health and safety.”

January 28, 2016: Walgreens says no customers’ tests will be done at Theranos’ lab in California.

January 29, 2016: Theranos stops drawing blood from patients at Capital BlueCross’ Pennsylvania store. The move follows health inspectors’ findings of deficiencies at the blood tester’s California lab.

February 4, 2016: Theranos advertises that it’s on the lookout for a… writer? One able to “handle stressful situations.”

February 10, 2016: Another Wall Street Journal scoop — Walgreens has threatened to end its relationship with Theranos unless the floundering company fixes the issues pointed out by CMS two weeks earlier. The warning was issued in a letter to Theranos in late January, giving it a 30-day deadline to resolve the patient safety issues. The 40 wellness centers in Arizona-based Walgreens stores are the primary source of revenue for Theranos at this point.

March 3, 2016:  At the last minute, Holmes backs out of an appearance at Scripps Health’s Future of Genomic Medicine conference.

March 8, 2016: The Wall Street Journal reports that a federal inspection report found “deficient practices” in quality-control checks at the California lab.

March 9, 2016: Vanity Fair editors probably wish they could turn around major features much faster, as the scandal-plagued Holmes appears with the likes of Mark Zuckerberg, Elon Musk, Maria Shriver, J.J. Abrams and other movers and shakers in a group photo shot months earlier by Annie Leibovitz.

March 21, 2016: Holmes hosts a fundraiser for Hillary Clinton in San Francisco. Bad publicity forced the event to be moved from Theranos headquarters in Palo Alto, California. Don’t be surprised to see this photo of Holmes with Chelsea Clinton in negative campaign ads this fall.

March 28, 2016: A peer-reviewed study in the Journal of Clinical Investigation found that Theranos cholesterol tests were significantly less accurate than traditional screenings performed by Lab Corp. and Quest Diagnostics.

March 31, 2016: The Edison diagnostic devices developed at Theranos couldn’t even match the company’s own quality control standards, according to a new CMS inspection report reviewed by the Wall Street Journal.

April 7, 2016: Theranos expands its Scientific & Medical Advisory Board to include people known more for their, you know, actual scientific work than for their vanity names.

Theranos: THREATS AND DAMAGE CONTROL

April 13, 2016: CMS proposes severe sanctions on Theranos, including the revocation of its California lab license and a two-year ban from running a clinical lab for Holmes and President Sunny Balwani.

April 18, 2016: A part defiant, part contrite Holmes appears on NBC’s “Today” show and says she’s “devastated” by the failures of her company. While Holmes is in New York, Theranos issues a press release promising that the erstwhile founder would pull the veil back on the company’s technology and research at the the American Association for Clinical Chemistry‘s annual scientific conference in August. 

Later in that eventful day, the Wall Street Journal reports that Theranos is the subject of a criminal investigation.

April 27, 2016: The second-guessing heats up, as Bloomberg notes, “The big question is turning from whether the company will eventually prevail to why so many people were so enamored of it in the first place.”

May 12, 2016: Balwani leaves the company as part of a board reorganization.

May 18, 2016: Theranos tells CMS that it has invalidated two years of blood-test results from the Edison testing devices.

May 19, 2016: Remarkably, Theranos marches ahead with expansion plans, including a new lab in Pennsylvania. “Among the open positions being advertised: two assistants to CEO Elizabeth Holmes, one personal and one executive assistant. Candidates are expected to exercise “a high degree of discretion and confidentiality,” STAT reports. As one Facebook comment puts it, “Thelma and Louise floor it.”

May 25, 2016: The Wall Street Journal reports that Walgreens executives had doubts about Theranos prior to investing at least $50 million into the then-hot startup in 2013, but Holmes and her scientists didn’t adequately answer their questions, nor did they let Walgreens inspect the Newark, California, lab. Still, Walgreens moved ahead with the deal for fear of losing Theranos to a competitor.

The same day, an Arizona man sues Theranos for consumer fraud as his attorneys move to make the case a class action, according to The Verge. At least seven more fraud suits have been filed against the company.

June 1, 2016: Forbes, which had called Holmes America’s richest self-made woman and the world’s youngest self-made female billionaire, revised Holmes’ net worth to zero, down from $4.5 billion. The publication pegged the valuation of Theranos at $800 million rather than $9 billion.

June 9, 2016: Now the story gets ridiculous. Hollywood publication Deadline reported that there’s a Theranos movie in development, and it’s going to star none other than Jennifer Lawrence as Holmes. Just who would be the protagonist, though?

June 12, 2016: Walgreens terminates its contract with Theranos, closing all 40 Theranos Wellness Centers in Arizona and depriving the testing company of its largest customer. A single Theranos Wellness Center in California had previously shut down.

July 7, 2016: In a press release sent out at 11:35 p.m. Eastern time, Theranos confirms that CMS has moved to terminate the company’s CLIA license for the California lab, bar Holmes for two years, pull Medicare and Medicaid billing privileges and impose an unspecified civil fine. The sanctions are due to take effect 60 days later, and don’t fully shut down hematology services.

July 8, 2016: In another press release, Theranos talks like it has no intention of going out of business and hints that it may appeal the CMS decision. According to the statement, “the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes.” Theranos also shares the sanction letter from CMS.

July 10, 2016: The Wall Street Journal reports that Holmes wants Hollywood to tell her own version of the Theranos story. “She has also been talking with Jason Blum, who was executive producer of HBO’s ‘The Jinx: The Life and Deaths of Robert Durst,’ about a potential documentary that would chronicle her life and career, people familiar with the matter said.”

July 19, 2016: Theranos is sued by an Arizona man who claimed that an inaccurate blood test resulted in medical decisions that triggered a heart attack. The plaintiff seeks class-action status.

July 21, 2016: Theranos shuffles the deck again, hiring Dave Wurtz as VP of regulatory and compliance efforts and Daniel Guggenheim as chief compliance officer. The company’s board also creates a Compliance and Quality Committee. What took them so long?

Theranos: REBOOT AND REPERCUSSIONS

Aug. 2, 2016: Holmes pulls what at least one observer called called a “bait and switch” at the American Association for Clinical Chemistry Annual Scientific Meeting in Philadelphia. Her long-anticipated address was supposed to include peer-reviewed data on Edison, but instead, Holmes previewed an entirely new product, a lab in a box called miniLab. The move is widely seen as an attempt to reboot Theranos.

Aug. 25, 2016: Theranos says it will appeal the CMS sanctions imposed in July. The company keeps the Newark lab shut.

Aug. 30, 2016: The Journal reports that Theranos has withdrawn a request for emergency FDA clearance of a test for the Zika virus. An FDA investigation apparently turned up sloppy research practices. Still, Theranos tries to put on a happy face to the public.

Sept. 6, 2016: Another national publication gets in on the investigative action. Vanity Fair publishes an in-depth piece that got inside Theranos’ culture of secrecy. The article paints Holmes as a control freak who kept employees siloed by department, has a personal secuirty detail, won’t let outsiders write peer-reviewed research on Theranos technology and who convinced her employees that Carreyrou got the story wrong. Holmes just stuck to her “narrative,” facts and human feelings be damned.

Sept. 20, 2016: Vanity Fair special correspondent Nick Bilton, who wrote the exposé two weeks earlier, gives a peek into the sausage-making of putting together an investigative report. It’s a fascinating behind-the-scenes look that describes how current and past employees were so willing to talk to Bilton. It also suggests Holmes didn’t want to give up her spot on the A List so soon: “In recent weeks, despite these federal investigations, she has been spotted at affluent dinner parties in Silicon Valley, and in photos on social media, grinning at a Fashion Week party while hanging out with Serena Williams, Uncle Jxm and D.J. Jubilee.”

Sept. 22, 2016: Despite the CMS sanctions that took effect Sept. 5, the Scottsdale lab remained open while Theranos appealed the decision, the Arizona Republic reported.

Oct. 5, 2016: Holmes announces that the embattled company was shutting down its clinical labs and direct-to-consumer blood testing services — the core of what Holmes has been working on since she dropped out of Stanford University in 2004. Instead, Theranos would focus on the miniLab, the product Holmes unveiled in July.

Oct. 10, 2016:  Hedge fund Partner Fund Management, which had invested $96.1 million in 2014, sues Theranos, claiming securities fraud. The suit said Theranos overstated the scope of its submissions for FDA approval and its ability to meet the obligations with Walgreens.

Oct. 20, 2016: The Wall Street Journal publishes a feature story about “agnonized patients” hurt or misled by inaccurate Theranos test results.

Nov. 8, 2016: Walgreens sues Theranos for $140 million, claiming breach of contract. The filing was placed under court seal.

Nov. 15, 2016: A federal judge in Delaware releases a heavily redacted version of the Walgreens suit, and the document paints a picture of incompetency and deception. Like an R-rated movie shown on broadcast TV, a lot of the good parts were cut out.

Nov. 18, 2016: The Journal outs the Theranos whistleblower, former employee Tyler Shultz. He just happens to be the grandson of George Shultz, and he was the first to report shortcomings to regulators, in this case, New York state’s public health lab. “In early 2015, Mr. Shultz began speaking to a Journal reporter as a confidential source,” Carreyrou wrote, in a highly unorthodox move by a journalist. It has caused a rift in the Shultz family, but the grandson reportedly continued to cooperate with federal prosecutors.

Nov. 29, 2016: Now it gets good. Consumer rights law firm Hagens Berman Sobol Shapiro announced it filed a class-action suit on behalf of Theranos investors, but that isn’t even the biggest news of the day. The Journal named several key Theranos investors, including Rupert Murdoch, who put in $100 million. Murdoch happens to control News Corp., owner of the Wall Street Journal.

Dec. 1, 2016: Theranos says it intends to do away with the vanity Board of Counselors as of Jan. 1. That means Kissinger, Shultz, Nunn, Frist, Perry and the like will be cut loose.

Dec. 2, 2016: President-elect Donald Trump chooses Mattis, a Theranos board member, to be secretary of defense in the new administation. That same day, the Washington Post reports that it has obtained emails between Holmes and Mattis. The correspondence showed that Holmes asked the general in 2012 to intervene in an effort to get Theranos testing equipment deployed to the battlefield, despite a military reviewer warning the FDA that Theranos wanted to distribute uncleared technology. Fortune reports that Mattis intends to stay on the board.

Dec. 5, 2016: More emails come out, courtesy of the Wall Street Journal, as do the names of dozens of investors because Theranos forgot to use “BCC:” in a message sent a few days earlier. Recipients included representatives of the Walton family (of Walmart fame), New England Patriots owner and Trump confidant Robert Kraft, an executive of a company founded by Mexican multibillionaire Carlos Slim and an investment firm tied to diamond company De Beers. Other emails indicated Holmes had forecast 2016 profits of $505 million on revenues approaching $2 billion when soliciting investors in 2014 and 2015.

Photo: Wikimedia Commons

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