Theranos founder and CEO Elizabeth Holmes speaking in San Francisco last year.The Edison machines were touted as revolutionary and were the main basis for the $9 billion valuation attained by the Palo Alto, Calif., company in a funding round in 2014.The company has told the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, voiding some results and revising others, according to the person familiar with the matter.In response to questions from The Wall Street Journal about the blood-test corrections, Theranos spokeswoman Brooke Buchanan said: Excellence in quality and patient safety is our top priority and we ve taken comprehensive corrective measures to address the issues CMS raised in their observations.As these matters are currently under review, we have no further comment at this time.CMS also has threatened to revoke the California lab s federal license and impose fines against Theranos.
Troubled startup Theranos has voided two years' worth of blood-test results from its flagship Edison machines, reports The Wall Street Journal.Those machines are Theranos' main claim to fame.CEO Elizabeth Holmes rose to prominence on the huge promise that, with Edison, Theranos can test for blood-borne diseases with only a pinprick of blood from a fingertip.But amid larger concerns over the accuracy and viability of the Edison technology, Theranos has told federal regulators that it's thrown out all results from 2014 and 2015.That includes tests that Theranos did with Edison, as well as the ones it performed with traditional lab equipment, according to The Journal's report.That means that anybody who got a Theranos blood test during that period may have gotten wrong results.The Journal report indicates that physicians in Phoenix have gotten corrected results from Theranos in recent weeks.In fact, one patient went to the emergency room in 2014 based on a Theranos blood-test result, says the report — a result that's now been amended.The move to throw the test results out is a sign that Theranos is trying to show government agencies that it can regulate its own shortcomings."We've taken comprehensive corrective measures to address the issues CMS raised in their observations.As these matters are currently under review, we have no further comment at this time," the company said, referring to the US Centers for Medicare and Medicaid Services.NOW WATCH: How NASA s groundbreaking work on human blood can predict your reaction to certain drugsLoading video...
Troubled bio-tech startup Theranos has told the Centers for Medicare and Medicaid Services CMS that it voided two years of results from the blood tests that it once staked its future on, reports the Wall Street Journal.According to the WSJ, Theranos also told the CMS—which is currently investigating the startup for compliance issues—that it has issued tens of thousands of corrected blood test reports to doctors and patients, with some results voided and others revised.TechCrunch has contacted Theranos and the CMS for comment.The WSJ spoke to several doctors near Phoenix, Arizona who said they had received corrected reports, including one physician who sent a patient to the emergency room based on erroneous results from Theranos.The CMS is just one of several federal agencies currently investigating Theranos for issues connected to its diagnostic tests and business operations.The CMS investigation revolves around compliance issues at Theranos main lab in Newark, California and may result in a two-year suspension from owning or running a lab for Elizabeth Holmes, the company s founder, and Sunny Balwani, its former president.
You have to wonder what other errors Theranos has that it s going to need to correct.The latest issue surrounding the troubled lab-technology company: It has voided the results of two years worth of blood tests that were done with Theranos Edison blood-testing devices.The Wall Street Journal reported that Theranos has re-issued thousands of test results that it has corrected.The company processed approximately 890,000 tests a year in its labs.You read that right: Two years of blood tests were basically stricken from the record.The company s valuation ended up being based on a technology that Theranos itself had given up on.All of that can t help Theranos case that the doors of its Palo Alto headquarters, and its testing labs, should be kept open.The Centers for Medicare and Medicaid services are still considering pulling Theranos license to operate labs in California, and have proposed kicking Theranos Chief Executive and founder Elizabeth Holmes out of the blood-testing industry for two years and fining the company, to boot, according to the Journal.Last week, Sunny Balwani stepped down from his president and chief operating officer posts at Theranos rather than face the possibility of a two-year ban from the blood-testing industry himself.Photo: Theranos CEO Elizabeth Holmes in 2014.
Theranos CEO and founder, Elizabeth HolmesAfter federal regulators threatened to revoke Theranos license to perform blood tests and ban its CEO and COO from the industry altogether, the company reportedly issued tens of thousands of corrections to blood tests it performed.Theranos has also voided all of the 2014 and 2015 results reported from its once-famed Edison blood testing machines, according to the Wall Street Journal.The Edison machines, which were said to be able to perform more than 200 medical tests with just a few drops of blood, were key to the young biotech company earning a whopping $9 billion valuation in 2014.Yet, in the wake of reports that the machines were inaccurate and unreliable and that employees were unqualified and failing to follow proper protocols and fix problems, the company acknowledged that it had completely stopped using the devices in June 2015.The unprecedented number of corrected lab results are just one of the steps Theranos is taking to try to appease the Centers for Medicare and Medicaid Services, which in March threatened to revoke the company s license and ban CEO and founder Elizabeth Holmes, and its president and COO, Sunny Balwani, from blood testing.Theranos has since hired new clinical laboratory advisors and it was announced last week that Balwani is leaving the company.
Theranos' business model is built on the idea that it can offer more than 100 simple blood tests directly to patients at a much lower cost than traditional blood labs, ideally using its own technology to test that blood with only a finger-prick.But it has faced accusations about the validity of its technology since last year, and in January the Centers for Medicare and Medicaid Services found problems with its Northern California lab in January, saying some of its practices "pose immediate jeopardy to patient health and safety.Its founder Elizabeth Holmes said in a TV interview recently that, "we stopped testing and have taken the approach of saying, 'Let s rebuild this entire lab from scratch so that we can ensure it never happens again.Take a consumer genetics test, for example: Rather than making an appointment at the doctor, sitting for an array of expensive genetic tests, waiting days for the results and then having to trek back to the office to discuss them at your physician's convenience, the company offered a simple, straightforward alternative: Spit in a tube, mail it in, and get results online in a visual, simple-to-understand format.Theranos has been doing something similar, but with blood instead of spit."We've taken comprehensive corrective measures to address the issues CMS raised in their observations.Many "disruptive" Silicon Valley health companies have run into this regulatory problem as well.But because Theranos focuses on blood tests, which provide information that the average person could act on, like diagnosing a sexually transmitted disease or monitoring an existing diagnosis, Theranos faces an additional scrutiny.For example, a patient who had gotten a blood test through Theranos went to the emergency room in 2014 after a blood-test result that showed abnormally high results, The Journal reported."Holmes then went on to explain, in veiled terms, a bit about how the company runs its tests in an attempt to dispel some claims about dilution methods.
Photo: Jeff Chiu/APTroubled start-up Theranos has voided some two years' worth of blood-test results from its flagship Edison machines, reports The Wall Street Journal.But amid larger concerns over the accuracy and viability of the Edison technology, Theranos has told federal regulators that it's thrown out all results from 2014 and 2015.The move to throw the test results out is a sign that Theranos is trying to show government agencies that it can regulate its own shortcomings.That's important because Theranos is facing a criminal investigation and it's trying to prevent further problems."We've taken comprehensive corrective measures to address the issues CMS raised in their observations.As these matters are currently under review, we have no further comment at this time," the company said, referring to the US Centers for Medicare and Medicaid Services.
This same technology helped Theranos raise hundreds of millions of dollars from investors.And, combined with the company s marketing and its cut-rate prices, brought in business from millions of customers.To investors, Theranos is probably starting to look less like a glimmering unicorn and more like a nightmare.Not only has the Journal s relentless, year-plus investigation exposed the company s technological stumbling and lab protocol bumbling, it brought down investigations from several federal and state agencies, including the Securities and Exchange Commission and the Department of Justice.The SEC is looking for evidence of investor fraud, by subpoenaing documents from Theranos and the venture capitalists who gave the company money.Venture capital is risky even when it doesn t involve a company imploding in slow motion.
Witness the debacle that has dogged Theranos Inc. and its promise of being able to run multiple blood tests based on very small samples using its proprietary Edison device.Now, the WSJ is reporting that Theranos has 'voided' two years of Edison blood tests.It underscores the fact that Theranos has been unable to meet standards for accuracy advertised by Edison, a fact revealed during an FDA inspection of the company's facilities that showed substantial documentation of the product's failure.Needless to say, a blood testing device that cannot produce reliable results is potentially disastrous to individuals and medical practioners seeking to make treatment or lifestyle decisions based on the data provided by Theranos.The company's founder and CEO Elizabeth Holmes is facing a potential ban on providing blood testing services for as long as two years from federal regulators, as is recently-departed executive Sunny Balwani.Edison tests were available primarily through Walgreens pharmacy locations, which is a partnership that also looks to be in doubt as regulatory agencies circle Theranos in a bid to shut down its operations.
ASSOCIATED PRESSThe Theranos saga hit another low last week when the company informed regulators that it was voiding two years of tests from its Edison blood testing devices and sending of tens-of-thousands of revised tests results to doctors.Sadly, we have seen too much of this in the technology world — ethical lapses and lack of disclosure to shareholders.Look for leaders who engage in debate with people who understand the core technology and may fortify or enhance the original concept.Beware of leaders who hide behind the cloaks of marquee names.When they join a board, venture capitalists have a fiduciary duty to represent the interests of all shareholders, not only their funds.Their prominent governance apologists celebrated e-board governance, a self-righteous term replacing traditional diligent governance.
Walgreens was considering a partnership with Theranos Inc. when founder Elizabeth Holmes arrived at Johns Hopkins University in the spring of 2011.The results were actually really good, but I was never allowed to go into the lab.In a bid to avoid stiff government sanctions, Theranos recently told regulators it has issued tens of thousands of corrected blood-test reports to doctors and patients.Walgreens was founded in Chicago in 1901 and had about 7,500 drugstores in 2010 when it decided to jazz up its image and find new technology.Mr. Balwani, whose resignation from Theranos was announced this month, couldn t be reached.Despite their limited access, Walgreens executives decided to keep working on an agreement.
Things keep getting worse for Theranos.A new lawsuit accuses Thernos of misleading customers about the accuracy of its blood tests, a week after the embattled Palo Alto company reportedly admitted to voiding two years of results.The class-action lawsuit filed in San Francisco federal court on Wednesday claims Theranos breakthrough product, which was supposed to provide a revolutionary way to conduct tests with just a few drops of blood taken from a patient s finger, didn t work.As a result, tens of thousands of patients may have been given incorrect blood-test results, been subject to unnecessary or potentially harmful treatments, and/or been denied the opportunity to seek treatment for a treatable condition, the complaint states.The Edison machines, used at Walgreens Pharmacies in California and Arizona to conduct the finger-prick tests, have caused Theranos significant headaches.The Wall Street Journal reported last week that the company told federal regulators it threw out all Edison test results for 2014 and 2015.The Centers for Medicare and Medicaid services are considering pulling Theranos licenses and banning founder Elizabeth Holmes from the industry.The lawsuit, brought on behalf of an Arizona man, claims Theranos told patients its tests were accurate and validated by the FDA and other bodies, when in reality the company was in hot water with regulators over its lack of compliance.In February 2015, an Edison device testing hormone levels failed 87 percent of quality-control checks, according to the complaint.The suit also claims Theranos misled the public by claiming it was using the Edison devices for certain tests, when it really wasn t.The suit seeks to represent thousands of people who purchased Edison blood tests.Photo: Elizabeth Holmes spoke about Theranos vision at the company s headquarters in Palo Alto in 2014.Karl Mondon/Bay Area News Group Tags: Theranos
Theranos CEO and founder Elizabeth Holmes.Apparently, Walgreens also feels hoodwinked.Currently, Theranos runs 45 wellness centers in Arizona and California, including 40 in Walgreens stores.Prior to signing the deal, Walgreens executives and consultants made several attempts to look over Theranos shoulder and check that its famed Edison blood testing devices worked as the company said.But the machine only spit out test results such as low and high so that Walgreens couldn t compare the results to standard blood testing equipment.Those broken promises and the risks they posed to patient health spurred two Theranos patients to file lawsuits against the company Wednesday and Thursday, respectively.
Last year, Elizabeth Holmes, the founder of troubled blood-testing company Theranos, was at the top of Forbes Richest Self-Made Women list with an estimated net worth of $4.5 billion, making her the first youngest self-made female billionaire.Forbes wrote that its estimate was based solely on her 50 percent ownership in Theranos, which was valued at $9 billion in 2014.Without it, Holmes s net worth looks quite different:Forbes spoke to a dozen venture capitalists, analysts and industry experts and concluded that a more realistic value for Theranos is $800 million, rather than $9 billion.It also represents a generous multiple of the company s sales, which Forbes has learned about from a person familiar with Theranos finances.Last week, Theranos announced it had voided two years of blood test results because of potential inaccuracies.Because Theranos investors own preferred shares, Forbes explains, they would get reimbursed before Holmes, who owns common stock.
Theranos CEO Elizabeth Holmes speaks during the Clinton Global Initiative s annual meeting in New York on Sept. 29, 2015.That, plus new information indicating Theranos annual revenues are less than $100 million, has led FORBES to come up with a new, lower estimate of Theranos value.But little is known about the company s future, Forbes noted, and so far the firm seems at best badly managed and at worst a calamitous ruse.In March, federal health regulators proposed banning Holmes from the blood-testing industry for two years.Theranos spokeswoman Brooke Buchanan told The Huffington Post in an email that people shouldn t put too much stock in the Forbes report.The whole affair underscores the problems that come from valuing the net worths of startup executives whose assets are not easily converted into cash, as Fortune s Dan Primack noted in his morning newsletter.
Theranos CEO Elizabeth Holmes is worth exactly $0, according to Forbes, the go-to publication for assessing the wealth of the world's billionaires.Last month Theranos, the troubled blood-testing startup, voided two years' worth of blood-test results from its flagship Edison machines.This is just the latest in a series of blows for the company, which began with a high-profile exposé from The Wall Street Journal last year that called the company's underlying technology into question.How did Forbes arrive at the $0 number?Here is the methodology:FORBES spoke to a dozen venture capitalists, analysts and industry experts and concluded that a more realistic value for Theranos is $800 million, rather than $9 billion.That gives the company credit for its intellectual property and the $724 million that it has raised, according to VC Experts, a venture capital research firm.It also represents a generous multiple of the company s sales, which FORBES learned about from a person familiar with Theranos finances.Based on this, Forbes concluded that Holmes' 50% stake in Theranos is worth nothing.This is because she owns common stock, and would get paid out after investors who own preferred shares, according to VC Experts.So even if Theranos were liquidated, she wouldn't likely see any of that $800 million.NOW WATCH: There s an incredible new workout on water where you run on floating matsLoading video...
MoreTheranos Chief Executive Officer Elizabeth Holmes speaks on stage at the Glamour Women of the Year Awards where she receives an award, in the Manhattan borough of New York November 9, 2015.REUTERS/Carlo Allegri Reuters - Forbes magazine on Wednesday reduced its estimate of the net worth of Elizabeth Holmes, the founder and chief executive of health technology company Theranos Inc, to zero from $4.5 billion last year.Theranos spokeswoman Brooke Buchanan responded to the report saying, "As a privately held company, we declined to share confidential financial information with Forbes.Explaining why it reduced its estimate of Holmes' wealth for the same list this year, Forbes said her fortune was based entirely on her 50 percent stake in Theranos, a stake that has suffered in value amid questions over the company's diagnostic capabilities.If that were to happen, participating preferred investors would get their money back and more before Holmes gets a cent."Holmes founded Theranos in 2003 and it promised ground-breaking methods that would allow quick results for a wide range of tests with just one drop of blood.
Theranos CEO and founder Elizabeth Holmes.With bunk blood tests and medical equipment, possible federal sanctions, a criminal probe, voided patient reports, and possible class action lawsuits, Theranos has taken quite the hit.On Wednesday, Forbes put dollar values to that hit.The business magazine reported that the company s valuation—based on a dozen venture capitalists, analysts and industry experts —has been downgraded from its $9 billion estimate 2014 to just $800 million now.In a statement, Theranos spokesperson Brooke Buchanan fired back at the new valuations, saying: As a privately held company, we declined to share confidential information with Forbes.Forbes gave three reasons that Theranos has lost value: too many questions about its work remain; it s have failed to deliver data on its tests and machines; and it s unlikely to outdo its competitors.
Elizabeth Holmes, the once celebrated founder of Theranos, sat at number one on Forbes list of richest self-made women last year but has taken quite the tumble – the media outlet has since revalued her net worth to zilch.Holmes, 31, comes from a family with powerful political connections – both parents held important government positions in Washington – which helped her get her start and Holmes was reportedly worth $4.5 billion in stock for her blood analysis company.As a privately held company, we declined to share confidential information with Forbes, Theranos spokesperson Brooke Buchanan told TechCrunch.As a result, the article was based exclusively on speculation and press reports.She launched it out of stealth more than 10 years later, with backing from DFJ, Henry Kissinger, and others but came under scrutiny after several damning investigative pieces in the Wall Street Journal.The company now faces charges from the SEC and federal regulators could revoke its operating license or oust Holmes if Theranos fails to adhere to certain terms.
Out of all the federal regulations turmoil, questionable test results and threats to oust her from her own company, Theranos founder Elizabeth Holmes is getting a silver screen lining – Jennifer Lawerence will play her in an upcoming movie.Deadspin reports The Big Short director Adam McKay will be making the film about the 32-year-old founder and her one drop medical startup once valued at $9 billion.Forbes recently downgraded Holmes portion of the company from $4.5 billion to zero after a series of unfortunate events read false advertising about its technology and a few government investigations left the company on shaky ground and valued it closer to $800 million – including the $724 million of capital raised.It might seem too soon for Theranos to get some Hollywood screen time but movies have been made out of much less before and this is one company that seems to have plenty of drama with the kind of strong female lead JLaw is keen to play.The film project is in the very early stages – no other actors have been attached to the film yet, there s no title or released date either, according to reports.Featured Image: Gage Skidmore/Flickr UNDER A CC BY 2.0 LICENSE