TAG:
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 Frederick Kiechle, MD, Molecular Pioneer, Dies at 78
By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue
Clinical pathology lost one of its greatest practitioners when pathologist Frederick L. Kiechle, MD, PhD, FCAP, of Cooper City, Fla., died on July 30, 2024, at the age of 78. …
Hurdles Continue When Labs Request Genetic Test Coverage
By Virchow | From the Volume XXXI, No. 13 – September 23, 2024 Issue
…
New Type of Competition from Investor-Owned Labs
By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue
CEO SUMMARY: More investor-funded lab companies see robust future growth in serving what The Washington Post calls “a booming online wellness market that aims to leave the doctor’s office behind. ” This is a new market driven by younger health care-minded consumers who turn to …
May 20, 2024, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
Last month, members of a class action lawsuit against Theranos and other defendants received settlement checks. Members of the class included TDR’s Editor-in-Chief, Robert Michel, and his wife, Deborah. On behalf of The Dark Report, the Michels had investigated the actual laborator…
Feds Bar Elizabeth Holmes from Government Health Programs
By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue
ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …
Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…
December 4, 2023, Intelligence: Late-Breaking Lab News
You may have thought that the long-running saga of the now-defunct Theranos had ended. But no, there is continuing litigation in the Grand Canyon State. A class action suit—In re Arizona Theranos, Inc., Litigation, Case No. 2:16-cv-2138—continues to move forward in …
September 11, 2023, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXX, No. 13 – September 11, 2023 Issue
Here’s another twist in the saga of Theranos, the defunct and discredited lab testing company. Consumers who received inaccurate results from Theranos’ blood tests may get some measure of justice. Walgreens Boot…
Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare
By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue
CLINICL LABORATORY AND ANATOMIC PATHOLOGY PROFESSIONALS have another reason to shake …
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. …
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
Topics
- Anatomic Pathology
- Clinical Chemistry
- Clinical Laboratory
- Clinical Laboratory Trends
- Digital Pathology
- Genetic Testing
- In Vitro Diagnostics
- IVD/Lab Informatics
- Lab Intelligence
- Lab Marketplace
- Lab Risk & Compliance
- Laboratory Automation
- Laboratory Billing
- Laboratory Compliance
- Laboratory Equipment
- Laboratory Information Systems
- Laboratory Management
- Lean Six Sigma
- Managed Care Contracts
- Molecular Diagnostics
- Pathology Trends
- People
- Uncategorized
The Dark Report • 21806 Briarcliff Dr • Spicewood, TX 78669
Phone: 512-264-7103 • Toll Free Number: 800-560-6363
Email: info@darkreport.com
© 2024 The Dark Report. All rights reserved.