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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.
Pathologist Sues Hulu Over Depiction in Theranos TV Series
By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue
THERE IS AN INTRUGUING NEW TWIST IN THE LONG-RUNNING SAGA of the now-defunct Theranos. Pathologist and former Theranos CLIA lab director Adam Rosendorff, MD, is taking Hulu to court. …
Elizabeth Holmes’ Appeal Questions Competence of CLIA Lab Director
By Scott Wallask | From the Volume XXX No. 4 – March 6, 2023 Issue
TANTALIZING DETAILS ABOUT FORMER THERANOS CEO ELIZABETH HOLMES’ purchase of a one-way plane ticket to Mexico prior to her conviction grabbed headlines following the filing of a motion to appeal her conviction. However, for clinical labo…
2022’s Top 10 Lab Stories Confirm Challenging Times
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
Holmes, Balwani Get Lengthy Prison Terms for Theranos Fraud
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
SENTENCING OF ELIZABETH HOLMES AND RAMESH “SUNNY” BALWANI in federal court caps the strange, yet captivating, saga of Theranos and its flawed blood testing technology. For laboratory professionals, the four years of legal wranglings that surrounded the Theranos fraud case may be remembered …
Ex-Theranos CEO Elizabeth Holmes Awaits Ruling on New Trial Request
By Scott Wallask | From the Volume XXIX, No. 15 – October 31, 2022 Issue
Keeping with the unexpected and odd circumstances surrounding Theranos, a federal judge heard arguments on Oct. 17 about whether convicted company founder Elizabeth Holmes’ should get a new trial. That hearing stemmed from the government’s star witness in Holmes’ 2021 tr…
How Genomic Testing Labs Can Improve Their Relationships with Payers
By Robert Michel | From the Volume XXIX, No. 14 – October 10, 2022 Issue
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Important Court Rulings & Pending New Federal Law
By R. Lewis Dark | From the Volume XXIX, No. 10 – July 18, 2022 Issue
IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…
Balwani Guilty! Sentencing Is Next for Theranos Execs
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
CEO SUMMARY: The trial of former Theranos President and Chief Operating Officer Ramesh “Sunny” Balwani ended with convictions by a jury on 12 counts of wire fraud and conspiracy. Now all eyes are looking ahead to the sentencing of Balwani and Elizabeth Holmes, the founder and fo…
Problems at Theranos Described in Balwani Trial
By Robert Michel | From the Volume XXIX, No. 6 – April 25, 2022 Issue
CEO SUMMARY: Former Theranos President and COO Ramesh Balwani is now being tried in federal court in San Jose, Calif. As with the earlier trial of Elizabeth Holmes, questions will arise about whether executives or clinical lab directors bear ultimate responsibility for lab test resu…
California Agency Problems Deepened Valencia Branch Laboratory Saga
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: Adding a new twist in the ongoing saga of the CLIA compliance failures at the Valencia Branch Laboratory in California are insights from a former clinical laboratory director familiar with the industry in California. He observed that problems at California’s Laborator…
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