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Theranos
Theranos was a failed blood analysis company that became notorious for gaining a $10 billion valuation without actually having proven, functional technology.
Theranos was founded by entrepreneur Elizabeth Holmes. Its name is a combination of therapy and diagnosis. Holmes founded the company in 2003, dropping out of Stanford University as a sophomore to do so.
The company announced that it would leave the clinical laboratory business in 2016 after becoming the target of a major expose by the Wall Street Journal, CMS sanctions, and numerous lawsuits. Theranos was ultimately dissolved in 2018 by David Taylor, its CEO at the time.
Theranos claimed it could perform hundreds of laboratory tests using a finger-stick collection and a micro-specimen vial instead of a needle and several vacutainers of blood. The company said it could return results in four hours for about half of the typical Medicare Part B lab test fees. This would have been exponentially less painful, faster, and cheaper than conventional blood testing performed by clinical laboratories. Theranos partnered with Walgreens in late 2013, with 41 Walgreens testing centers participating in this partnership at one point.
Theranos problems began with an in-depth investigative report by The Wall Street Journal in October 2015. This report was the result of information provided by whistleblowers whose concerns were ignored by both Holmes and Theranos’s President and Chief Operating Officer, Ramesh “Sunny” Balwani.
The Journal’s report revealed aspects of Theranos that the secretive company had kept from public view. Based on interviews with several employees and others with knowledge of events at Theranos, the Journal disclosed that the company ran only a handful of tests using its proprietary technology, relying on traditional testing for most of its specimen work. Following this exposé, Theranos quickly lost its role as the darling of the media and Silicon Valley.
In July 2016, the U.S. Centers for Medicare and Medicaid Services applied the most stringent sanctions it could to Theranos for problems it reported at the company’s lab in Newark, Calif., including a two-year prohibition on Holmes owning any CLIA-certified lab.
As a result of in-depth investigations, the U.S. Security and Exchange Commission (SEC) filed charges on March 14, 2018, stating that Theranos, Holmes, and Balwani allegedly raised more than $700 million from investors through an elaborate, years-long scheme that involved exaggerating or making false statements about the company’s technology, business, and financial performance.
To settle the SEC’s charges, Holmes agreed to pay a $500,000 fine and to surrender almost 19 million shares of Theranos stock and voting control of the company, the SEC said. Also, she was barred from running a public company for 10 years. At the time, Holmes did not admit to nor deny the charges. Balwani said he would contest the charges.
Three months later, the federal U.S. Department of Justice filed indictments against Holmes and Balwani.
Holmes’ trial was delayed multiple times due to the COVID-19 pandemic and her pregnancy. On January 3, 2022, Holmes was found guilty on three counts of defrauding investors and one count of wire fraud. She is scheduled to be sentenced in September 2022.
Balwani’s trial concluded on July 7, 2022, with him being found guilty on two counts of conspiracy and ten counts of wire fraud. Balwani is scheduled to be sentenced in November 2022.
March 14, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 4 – March 14, 2022 Issue
Telehealth proved to be popular with Medicare patients during the SARS-CoV-2 pandemic. The federal U.S. Department of Health and Human Services (HHS) reported telehealth visits for Medicare beneficiaries increased in 2020 by an incredible 63 times—from approximately 840,000 in 2019 to 52.7 m…
Newsmaker Interview
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
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Jury Finds Elizabeth Holmes Guilty in Four of 11 Criminal Counts
By Robert Michel | From the Volume XXIX, No. 1 – January 10, 2022 Issue
THERANOS’ FOUNDER ELIZABETH HOLMES received four convictions out of 11 charges in her blockbuster trial, which likely means a federal prison sentence for the former CEO. The guilty verdicts arrived Jan. 3 after months of testimony and jury deliberations…
2021’s Top 10 Lab Stories Highlight Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
This is an excerpt of a 3,075-word article in the December 20, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab stories for 2021. Beyond…
2021’s Top 10 Lab Stories Confirm Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
Theranos Lost $585 Mil. in 2015, Had Revenue of Just $500,000
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
AMONG THE BEST-KEPT SECRETS at Theranos during its glory days of 2013, 2014, and 2015—when the news media hailed now-disgraced founder and ex-CEO Elizabeth Holmes as a business genius to match Apple founder Steve Jobs—was the actual revenue the company was generating from its clinic…
In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role
By Robert Michel | From the Volume XXVIII, No. 16 – November 29, 2021 Issue
CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys question…
Third CLIA Lab Director Testifies in Trial of Elizabeth Holmes
By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
SOMETHING NEW AND UNEXPECTED SEEMS TO POP UP EACH DAY in testimony taken during the federal criminal trial of Elizabeth Holmes, founder and ex-CEO of Theranos, the defunct and discredited clinical laboratory company. Last Thursday, a third indivi…
CLIA Lab Director Testimony Shows Risks to Pathologists
By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…
Former Theranos Lab Director Makes News at Elizabeth Holmes Trial
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
This is an excerpt of a 1,867-word article in the October 18, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: During the trial, a pathologist who was a former Theranos lab director testified about the little…
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